Compliance exception incidents

Compliance exceptions allow supplier relationship managers, quality compliance managers, and manufacturing plant managers at companies that own or link to APT to collaborate with their internal locations and external Partners to record and report a variety of deviations for products throughout the supply chain. For example, a Dispenser in the US might receive a shipment of product with the tamper-proof foil seals broken. They can use the Compliance Exception incident process to alert relevant supply chain partners to the suspect product. Partners must be a member of the Owner company's network to collaborate with the Owner on a compliance exception incident.

Add a compliance exception

  1. Select a [Customer-defined APT Network] from the network drop-down in the header.
  2. Select a Team (e.g. your entire company or a Link to a specific Partner or internal location) in the header.
  3. Select the Compliance Exception Process in the header.
  4. Select the Go button in the header.
  5. Click Add in the Do menu.
  6. Fill in the following fields in the General section:
    1. Summary field – Required. A brief description of the incident (255 characters maximum).
    2. Description field – A detailed description of the incident (5000 characters maximum).
    3. Priority drop-down – Required. The urgency with which the issue must be resolved:
      • Low – The incident is low priority.
      • Medium – The incident is medium priority.
      • High – The incident is high priority.
      • Critical – The incident is critical.
    4. Resolution Due Date field – Required for Owners to submit the incident to the Partner or for Partners to add an incident. The date that the incident must be closed by.

    5.  Incident Category drop-down – The primary cause of the incident:

      • Data Issues – The product's data is incomplete or incorrect.
      • Damaged Product – The product was damaged during the packing, transportation, or filling process. This includes breakage, scratches, or particles resulting from damage.
      • Product But No Data – The product was received without the required supporting product details (e.g. lot number information).
      • Data But No Product – A product's details were received without also receiving the physical product.
      • Packaging – The product's packaging is inadequate or contains incorrect information, such as dosage or usage information.
      • Product Hold – The product's shipment was delayed or suspended due to quality concerns, safety issues, regulatory compliance, or other reasons.
      • Suspect Product – The product is believed to be potentially counterfeit, diverted, stolen, intentionally adulterated, the subject of a fraudulent transaction, or appears otherwise unfit for distribution.
      • Misalignment – There is a discrepancy between supply chain partners about the product (e.g. product specifications).
      • Tracing/Verification – The product's history cannot be properly traced or verified.
      • Other – The incident is caused by a user-defined problem.

    6.  Incident Sub-category drop-down – The subcategory of the selected incident category associated with the incident.

      • Non-Matching GLN – The GLN in the SOR (System of Record) does not match the GLN for the delivery.
      • GTIN Not Found – A GTIN in the delivery cannot be found in the SOR.
      • Incorrectly Formatted EPCIS – The delivery's EPCIS message is not formatted correctly.
      • Data Received/Barcode Data Misalignment – The delivery's data is present in the SOR, but it does not match the data retrieved from the delivery's physical barcode.
      • 004-Quarantine Product/No TL TI Data – The product in the delivery is in quarantine because the delivery’s transaction information is not present.
      • 005-Quarantine Product/Delivery Number/Barcode Mismatch – The product in the delivery is in quarantine because the delivery number or barcode does not match the information in the SOR.
      • 006-Quarantine Product/Product Number and Barcode Mismatch – The product in the delivery is in quarantine because a product number or barcode in the delivery does not match the information in the SOR.
      • 007-Quarantine Product/Misalignment Exception Amended – The product in the delivery is in quarantine because a misalignment occured.
      • Damaged Case or Case Label – The case or the case label for the product is damaged.
      • Damaged Each – An each-level container for the product is damaged.
      • 001-Quarantine Product/Damaged Barcode – The product in the delivery is in quarantine because the barcode is damaged.
      • 002-Quarantine Product/No Barcode – The product in the delivery is in quarantine because a product in the delivery does not have a barcode.
      • 003-Quarantine Product/Barcode Missing TI Data – The product in the delivery is in quarantine because the delivery’s transaction information is not present.
      • EPICS Sent But Not Received – The EPCIS message for the delivery was not received with the physical product.
      • Product Received But Serial Number Not Found/No PO or Delivery Number – The product is received but its serial number was not found or there is no PO number or delivery number for the product in the SOR.
      • Product Received But Serial Number Not Found/PO Exists – The product is received with an existing purchase order but its serial number was not found in the SOR.
      • Product Overage with Valid PO – The product has a valid purchase order but there is more product in the delivery than is present in the SOR.
      • Delivery to Right Company But Wrong DC – The product is delivered to the right company but to the wrong distribution center.
      • Delivery to Wrong Company – The product is delivered to the wrong company.
      • Serial Number Not Found Due to Aggregation or Overage During Pick/Pack/Ship – The product is received but its serial number was not found in the SOR due to an overage or aggregation error that occurred in the pick, package, and ship process.
      • Data Sent But Product Not Received (Possibly Due to Shortage) – A product’s data is received but the product is not received in the associated delivery, possibly due to a product shortage.
      • Data Received, Then Shipment Quantity Changed or Canceled – A product’s data is received but either the product is not received or the quantity of product received is incorrect.
      • Data Received, Shipment Refused or Undeliverable – A product’s data is received but the product is not received because the delivery was refused or was undeliverable.
      • Data Received, Shipment Lost or Stolen – A product’s data is received but the product is not received because the delivery was lost or stolen.
      • Scan On Receipt Product/Data Mismatch Due to Batch Labeling Issue – When the product is scanned on delivery, the information retrieved from the product label does not match the physical product.
      • No HRI of Serial Number On Label Upon Receipt – The product is received without a hierarchy of serial numbers on the label.
      • Serialized Shipping Container Code Damaged or Unusable – The product's SSCC is damaged or unusable.
      • 2D Barcode Will Not Scan, is Encoded Incorrectly or Has Incomplete Elements – The product's 2D barcode will not scan, is encoded incorrectly, or has incomplete elements.
      • No HRI Serial Number on Label at Pick/Pack/Ship – The product's hierarchy of serial numbers was not included on the label during the pick, package, and ship process.
      • EPCIS Events Out of Sequence, Do Not Match Product Status – The product is on hold because the events in the delivery's EPICS message are listed out of sequence or do not match the product’s current status.
      • Serial Number in Hold Status During Pick/Pack/Ship Due to Recall, Suspect, or Illegitimate Product – The product's serial number is updated to on hold during the pick, package, and ship process because the product is listed as recalled, suspect, or illegitimate.
      • Delayed Shipment – The product is on hold because its delivery is delayed.
      • Initial Notification – The product is being reported as suspect for the first time.
      • Follow-Up Notification – The product is being reported as suspect for at least the second time.
      • Request For Termination – The product is suspect and should be terminated.
      • Other – The incident is associated with an incident category not listed.
    7. Responsible User at Reporter Company field – Required. The user from the company that is accountable for the incident and is responsible for the incident's resolution (defaults to Unassigned if not entered).
    8. Reporter Company – The identifier for the company, company location, Partner company, or Partner company location that reported the incident and is responsible for the incident's resolution (defaults to Unassigned if not entered).

    9. Responsible Department at Reporter Company field – The business area of the company, company location, Partner company, or Partner company location responsible for the incident's resolution (defaults to the job function of the Responsible User at Reporter Company, if available):

      • Business Development – The user responsible for resolving the incident is part of a Business Development team.
      • Clinical Research – The user responsible for resolving the incident is part of a Clinical Research team.
      • Contract Management – The user responsible for resolving the incident is part of a Contract Management team.
      • Corporate Management – The user responsible for resolving the incident is part of a Corporate Management team.
      • Customer Service – The user responsible for resolving the incident is part of a Customer Service team.
      • Engineering – The user responsible for resolving the incident is part of an Engineering team.
      • Information Technology – The user responsible for resolving the incident is part of an Information Technology (IT) team.
      • Operations – The user responsible for resolving the incident is part of an Operations team.
      • Packaging – The user responsible for resolving the incident is part of a Packaging team.
      • Production or Manufacturing – The user responsible for resolving the incident is part of a Production team or Manufacturing team.
      • Project Management –The user responsible for resolving the incident is part of a Project Management team.
      • Purchasing – The user responsible for resolving the incident is part of a Purchasing team.
      • Quality Assurance, Control, or Validation – The user responsible for resolving the incident is part of a Quality Assurance (QA) team, Control team, or Validation team.
      • Research, Development, or Formulation – The user responsible for resolving the incident is part of a Research team, Development team, or Formulation team.
      • Sales or Marketing – The user responsible for resolving the incident is part of a Sales team or Marketing team.
      • Supply Chain – The user responsible for resolving the incident is part of a Supply Chain team.
      • Retail – The user responsible for resolving the incident is part of the Retail team.
      • Omnicare – The user responsible for resolving the incident is part of the Omnicare team.
      • Minute Clinic – The user responsible for resolving the incident is part of the Minute Clinic team.
      • Vanguard – The user responsible for resolving the incident is part of the Vanguard team.
      • Specialty Pharmacy / CarePlus – The user responsible for resolving the incident is part of the Specialty Pharmacy or CarePlus team.
      • Distribution Centers – The user responsible for resolving the incident is part of the Distribution Centers team.
      • PBM Mail Order – The user responsible for resolving the incident is part of the PBM Mail Order team.
      • PBM Specialty Mail – The user responsible for resolving the incident is part of the PBM Specialty Mail team.
      • Specialty Wholesale – The user responsible for resolving the incident is part of the Specialty Wholesale team.
      • Coram – The user responsible for resolving the incident is part of the Coram team.
    10. Current Assignees at Reporter Company field – Required. The users at the company that are accountable for the incident and are responsible for taking action to resolve the incident (defaults to Unassigned if not entered).

  7. Fill in the following fields in the Accountable Entity section:

    1. Accountable Entity field – The name and identifier of the company, company location, Partner company, or Partner company location that the incident is being submitted to. If a user at the Owner is adding the incident, the Partner must exist in Master Data Exchange and be linked to the current network. If a Partner user is adding the incident, this field displays the Partner company name.
    2. Responsible User at Accountable Entity field – Required. The user from the company that is accountable for the incident and is responsible for the incident's resolution (defaults to Unassigned if not entered).
    3. Current Assignees at Accountable Entity field – Required. The users at the company that are accountable for the incident and are responsible for taking action to resolve the incident (defaults to Unassigned if not entered).

  8. Fill in the following fields in the Delivery Information section:

    1. From Business field – The company that the product associated with the incident was ordered from.

    2. Shipped From Business field – The location that the product associated with the incident was initially shipped from.

    3. To Business field – The company that the product associated with the incident was ordered by.

    4. Shipped To Business field –The location that the product associated with the incident was shipped to.

    5. Notes field – General notes or comments about the entities associated with the incident.

  9. Fill in the following fields in the Attachment section:

    1. Attachments field – Drag and drop a file to attach or select the browse link to search for the file. The file name must not exceed 250 characters. For a list of supported file types, see What file types can I include in an attachment

  10. Fill in the following fields in the Impacted Product Details section:

    1. Product Name field – The name and Item or Packaging Code of the product affected by the incident, which must exist in the Owner's instance of Master Data Exchange.
    2. Product Details field – Read-only. High level product information (e.g. strength, dosage form, item code).
    3. Quantity Type drop-down – The state of the product in relation to its Purchase Order status.
      • Order
      • Item
      • Net
      • Gross
      • Pricing Unit
      • Committed
      • Damaged
      • Delivered
      • Delivery
      • Hold
      • In Transit
      • Invoice
      • Lading
      • Minimum Make to Order
      • Minimum Delivery
      • Minimum Order
      • On Hand
      • On Hold
      • On Order
      • Outstanding
      • Over
      • Packaged
      • Purchase Order
      • Questioned
      • Received
      • Rejected
      • Returned
      • Scrap
      • Shipped to Date
      • Short
      • Stock Keeping
      • Unusable
    4. Quantity Value field – The amount of product affected by the incident (12 characters maximum).
    5. Quantity Unit of Measure drop-down – The unit of measure associated with the product.
      • Ampoule – The product is measured in ampoules.
      • Bundle – The product is measured in bundles.
      • Bag – The product is measured in bags.
      • Bottle – The product is measured in bottles.
      • Box – The product is measured in boxes.
      • Bulk Box – The product is measured in bulk boxes.
      • Card or Blister – The product is measured in cards or blisters.
      • Centiliter – The product is measured in centiliters.
      • Capsule – The product is measured in capsules.
      • Case – The product is measured in cases.
      • Cubic Centimeter – The product is measured in cubic centimeters.
      • Cubic Feet – The product is measured in cubic feet.
      • Cubic Inch – The product is measured in cubic inches.
      • Cylinder – The product is measured in cylinders.
      • Centimeter – The product is measured in centimeters.
      • Can – The product is measured in cans.
      • Crate – The product is measured in crates.
      • Cartridge – The product is measured in cartridges.
      • Cubic Meter – The product is measured in cubic meters.
      • Carton – The product is measured in cartons.
      • Kilometer – The product is measured in kilometers.
      • Deciliter – The product is measured in deciliters.
      • Dispenser – The product is measured in dispensers.
      • Decimeter – The product is measured in decimeters.
      • Drum – The product is measured in drums.
      • Display – The product is measured in displays.
      • Dozen – The product is measured in dozens.
      • Each – The product is measured in eaches.
      • Fluid Ounce (US) – The product is measured in US fluid ounces.
      • Gallon (US) – The product is measured in US gallons.
      • Gaylord Box – The product is measured in gaylord boxes.
      • Gram – The product is measured in grams.
      • Gram or Liter – The product is measured in grams or liters.
      • Gross – The product is measured in grosses of product.
      • Hectoliter – The product is measured in hectoliters.
      • Kiloliter – The product is measured in kiloliters.
      • Kilogram – The product is measured in kilograms.
      • Kit – The product is measured in kits.
      • Pound (US) – The product is measured in US pounds.
      • Lot – The product is measured in lots.
      • Liter – The product is measured in liters.
      • Meter – The product is measured in meters.
      • Microgram – The product is measured in micrograms.
      • Microliter – The product is measured in microliters.
      • Milligram – The product is measured in milligrams.
      • Milliliter – The product is measured in milliliters.
      • Millimeter – The product is measured in millimeters.
      • Million – The product is measured in millions.
      • Ounce – The product is measured in ounces.
      • Pack – The product is measured in packs.
      • Package – The product is measured in packages.
      • Pair – The product is measured in pairs.
      • Pallet – The product is measured in pallets.
      • Piece – The product is measured in pieces.
      • Pint – The product is measured in pints.
      • Pouch – The product is measured in pouches.
      • Quart – The product is measured in quarts.
      • Roll – The product is measured in rolls.
      • Set – The product is measured in sets.
      • Sheet – The product is measured in sheets.
      • Square Centimeter – The product is measured in square centimeters.
      • Square Foot – The product is measured in square feet.
      • Square Inch – The product is measured in square inches.
      • Square Meter – The product is measured in square meters.
      • Tablet – The product is measured in tablets.
      • Thousand Piece – The product is measured in thousand pieces.
      • Thousand – The product is measured in thousands.
      • Tote – The product is measured in totes.
      • Tray – The product is measured in trays.
      • Tube – The product is measured in tubes.
      • Unit – The product is measured in units.
      • Vial – The product is measured in vials.
      6. Select the Add icon to add another Quantity Type, Quantity Value, and Quantity Unit of Measure.
    6. Serial Numbers field – The serial numbers of the impacted product.
    7. Lot Number field – The lot number of the product affected by the incident.
    8. Expiration Date field – The date that the impacted product expires.
      9. Select the Add icon to add another Lot Number and Expiration Date.

  11. Fill in the following fields in the Reference Transactions section:

    1. Reference ID Type drop-down – The type of shipping document that is associated with a delivery involved with the incident:

      • Bill of Lading – The transaction is identified by a Bill of Lading number.
      • Destruction Order – The transaction is identified by a destruction order number.
      • Invoice Number – The transaction is identified by an invoice number.
      • Nota Fiscal – The transaction is identified by a Brazil nota fiscal document number.
      • Packing Slip Number – The transaction is identified by a packing slip number.
      • PO Number – The transaction is identified by a purchase order (PO) number.
      • PRO Number – The transaction is identified by a PRO freight number.
      • Return – The transaction is identified by a return authorization number.
      • Sales Order Number – The transaction is identified by a sales order number.
      • Shipment Number – The transaction is identified by a shipment notification number.
      • Transfer Number – The transaction is identified by a transfer order number.
      • Other – The transaction is identified by another type of identification number.
    2. Value field – Conditionally required if a Reference ID Type is entered. The value of the selected Reference ID Type (72 characters maximum).
      3. Select the Add icon to add another Reference ID Type and Value.

  12. Fill in the following fields in the Suspect Product Details section:

    This section displays only if the Incident Category is Suspect Product.
    1. FDA Incident Number field – Conditionally required if an Incident Subcategory is Follow-up Notification. The incident number that has been provided by the FDA for the incident.
    2. Date of Initial Notification field – The date that the FDA was initially notified of the incident. The date selected cannot be more than 10 years before or after the current date.
    3. Illegitimacy Determined Date field – The date that the product associated with the incident was identified as illegitimate. The date selected cannot be more than 10 years before or after the current date.
    4. Notification Classification field – The reason the product was identified as illegitimate:
      • Counterfeit – The product is determined to be counterfeit or has a high risk of being counterfeit.
      • Diverted – The product is determined to be a diverted product or has a high risk of being a diverted product.
      • Stolen – The product is determined to be a stolen product or has a high risk of being a stolen product.
      • Intentional Adulteration – The product is determined to be intentionally adulterated such that use of the product has a high risk of resulting in serious adverse health consequences or death to humans.
      • Unfit for Distribution – The product appears unfit for distribution such that use of the product has a high risk resulting in serious adverse health consequences or death to humans.
      • Fraudulent Transaction – The product is determined to be or has a high risk of being the subject of a fraudulent transaction.
    5. Product Name on Label field – The name of the product as it is displayed on the physical label.
    6. Drug Composition field – The product's primary ingredients.
    7. Drug Use field – The intended type of end user for the drug:
      • Human – The product is intended to be consumed by humans.
      • Other – The product is not intended to be consumed humans.
    8. Drug Description field – The classification of drug:
      • Finished Prescription Drug – The drug is classified as a finished prescription drug.
      • Vaccine – The drug is classified as a vaccine.
      • Plasma Derivative (coagulation factors, immunoglobulins, albumin) – The drug is classified as a plasma derivative.
      • Allergenic (standardized and non standardized) – The drug is classified as an allergenic.
      • Multiple – The drug is classified in more than one way.
    9. Company Category field – The role of the company within the supply chain that identified the product as suspect:
      • Dispenser – The company responsible for dispensing the product identified it as suspect.
      • Manufacturer – The company responsible for producing the product identified it as suspect.
      • Repakager – The company responsible for repackaging the product identified it as suspect.
      • Wholesale Distributor – The company responsible for distributing the product identified it as suspect.
    10. Reason for Termination of Notification field – The reason that the previous incident notification submitted to a regulatory agency is void and is being withdrawn (5000 characters maximum).

    11. FDA Submission Method – The methods that were previously used to submit a suspect drug notification to the FDA for this product.

      • None switch – Indicates whether a drug notification was previously submitted to the FDA for this product.
        • Yes (default) – A drug notification was not previously submitted to the FDA for this product.
        • No – A drug notification was previously submitted to the FDA for this product.
      • BDPR switch – Indicates whether a drug notification was previously submitted to the FDA for this product using a Biological Product Deviation Report (BDPR).
        • Yes – A drug notification was previously submitted to the FDA for this product using a BDPR.
        • No (default) – A drug notification was not previously submitted to the FDA for this product using a BDPR.
      • FAR switch – Indicates whether a drug notification was previously submitted to the FDA for this product using a Field Alert Report (FAR).
        • Yes – A drug notification was previously submitted to the FDA for this product using a FAR.
        • No (default) – A drug notification was not previously submitted to the FDA for this product using a FAR.
      • Medwatch 3500 switch – Indicates whether a drug notification was previously submitted to the FDA for this product using the Medwatch 3500 form.
        • Yes – A drug notification was previously submitted to the FDA for this product using the Medwatch 3500 form.
        • No (default) – A drug notification was not previously submitted to the FDA for this product using the Medwatch 3500 form.
      • Medwatch 3500A switch – Indicates whether a drug notification was previously submitted to the FDA for this product using the Medwatch 3500A form.
        • Yes – A drug notification was previously submitted to the FDA for this product using the Medwatch 3500A form.
        • No (default) – A drug notification was not previously submitted to the FDA for this product using the Medwatch 3500A form.
      • Other switch – Indicates whether a drug notification was previously submitted to the FDA for this product using a method not listed here.
        • Yes – A drug notification was previously submitted to the FDA for this product using a method not listed here.
        • No (default) – A drug notification was not previously submitted to the FDA for this product using a method not listed here.
  13. Fill in the following fields in the Linked Processes section:

    1. Relationship field – The type of relationship the linked process has to the current incident:

      • Blocks – The linked process prevents the current incident’s resolution.
      • Blocked By – The current incident prevents the linked process's resolution.
      • Contains – The linked process is the parent of the current incident.
      • Contained By – The current incident is the parent of the linked process.
      • Dependent On – The linked process affects the current incident's resolution.
      • Dependency For – The current incident affects the linked process's resolution.
      • Relates To – The linked process is related to the current incident.
    2. Process ID field – The identifier or summary of another process related to the incident.
    Select the Add icon to add another linked process's Relationship and Process ID.

  14. Fill in the following fields in the Responses section:

    1. Internal Only switch – Required. Indicates whether team members from the Partner company associated with the incident can view the comments and attachments:
      • Yes – Only team members from the Owner can view the comments and attachments.
      • No – (default) Team members from the Partner associated with the incident can view the comments and attachments.
    2. Response Text field – Comments about the incident or explanations for the attachments (5000 characters maximum).
    3. Attachments field – Drag and drop a file to attach or select the browse link to search for the file. The file name must not exceed 250 characters. For a list of supported file types, see What file types can I include in an attachment
    Select the Add icon to add another row with the Internal Only, Response Text, and Attachments fields displayed.
    On the Search screen, select the icon in the row for the incident to open the Responses panel. The Responses panel shows a list of the last 3 comments on the compliance exception incident.

  15. Select Save (displays only if the user adding the incident has permission to submit incidents to the accountable entity).

    The compliance exception is saved.

    For Partners adding an incident on an Owner's network, selecting Save submits the compliance exception incident to the Accountable Entity. Partners cannot save a new compliance exception incident on the Owners network without submitting it to the Accountable Entity.

Partners who are on the Owner's TraceLink Network but do not use the Web UI can send compliance exceptions to the Owner's internal email (e.g. complianceexceptions@kendallpharma.com) in a format specified by the Owner.

To allow Partners to create compliance exceptions via email, the Owner must create an SMTP B2B connection in Extensible TraceLink Transfer, which generates a unique TraceLink email (e.g. apt_owner_6bba37c60eeb56@tracelink.com). The Owner must then automatically forward all compliance exceptions to the TraceLink-generated email. For more information about the configuration to receive compliance exceptions via email, see Configure Supply Chain Work Management.

Draft a compliance exception email

TraceLink suggests using the email format recommended by Healthcare Distribution Alliance. Supply Chain Work Management will create a compliance exception if the email has a subject line and description, but will not filter spam. A sample format for a compliance exception email is provided below:

Subject line - Buyer (or Distributor) | Seller (or Manufacturer) | Incident Category | Identifier.

Body - Include information about the problem, the company involved, the product, and also list the impacted serial numbers in a comma-separated format.

Modify a compliance exception

When a user assigned as the Responsible User at Reporter Company or a Current Assignee at Reporter Company is ready to submit the incident for investigation, that user submits the incident to the Accountable Entity so that they are alerted to the incident and can begin reviewing and investigating it.

  1. Select a [Customer-defined APT Network] from the network drop-down in the header.
  2. Select a Team (e.g. your entire company or a Link to a specific Partner or internal location) in the header.
  3. Select the Compliance Exception Process in the header.
  4. Select the Go button in the header.
  5. Click Search in the Do menu.
  6. Filter to find the incident.
  7. Select the Action icon in the row for the incident.
  8. Select View Incident.

  9. Select the Edit icon in the General section to fill in the following fields:

    1. Resolution Due Date field – Required. The date that the incident must be closed by.
    2. Select Save.

  10. Select the Edit icon in the Accountable Entity section to fill in the following fields:

    1. Accountable Entity field – Required. The name and identifier of the company, company location, Partner company, or Partner company location that the incident is being submitted to. If a user at the Owner company is adding the incident, the Partner must exist in Master Data Exchange and be linked to the current network. If a Partner user is adding the incident, this field displays the Partner company name.
    2. Select Save.

  11. Select Submit to Entity

    The incident is saved and submitted to the Accountable Entity specified for review. The incident Status is updated to Under Investigation and users at the Partner company are notified depending on their settings.

When the compliance exception's investigation is complete and an acceptable final response has been provided, any user with the Close permission can close the incident so that other users know the investigation is complete and the incident is resolved.

  1. Select a [Customer-defined APT Network] from the network drop-down in the header.
  2. Select a Team (e.g. your entire company or a Link to a specific Partner or internal location) in the header.
  3. Select the Compliance Exception Process in the header.
  4. Select the Go button in the header.
  5. Click Search in the Do menu.
  6. Filter to find the incident.
  7. Select the Action icon in the row for the compliance exception.
  8. Select View Incident.
  9. Select Closed from the Status drop-down in the top right of the screen.

  10. Fill in the following fields in the Close Compliance Exception [Exception ID] panel:

    1. Resolution Type drop-down – Required. The reason why the incident is being closed:

      • Resolved – The problem that caused the incident is resolved. This resolution type cannot be selected if the incident Status was changed from To Do to Closed.
      • Duplicate – An incident for the problem already exists.
      • Not an Issue – The incident was created in error and the investigation determined there was not actually a problem.
      • Other Resolution Type – If selected, fill in the text field that displays with the final outcome of the incident.
    2. Reoccurring Incident checkbox – Select this checkbox to indicate that the incident has previously occurred one or more times.

    3. Final Root Cause field – Required. The main issue that directly caused the incident to occur:

      • Documentation – The incident occurred due to a documentation issue.
      • Equipment – The incident occurred due to an equipment issue.
      • Material – The incident occurred due to a material issue.
      • Procedure – The incident occurred due to a procedural issue.
      • Process – The incident occurred due to a process issue.
      • Root Cause Not Attributed to Partner – The root cause of the incident cannot be attributed to the Partner.
      • Other Final Root Cause – If selected, fill in the text field that displays with the main issue that directly caused the incident to occur.
    4. Disposition Type field - The product action taken as a result of the incident:
      • Approve (release) – The compliance exception is within acceptable business standards. The product is approved for release.
      • Reject (OV return) – The compliance exception is not within acceptable business standards. The product is returned to an outside vendor.
      • Reject (NSR return) – The compliance exception is not within acceptable business standards. The product is returned as non-saleable.
      • Reject (other) – The compliance exception is not within acceptable business standards. The product is returned for an unspecified reason.
    5. Closing Statement field – Additional comments about the incident's closure (500 characters maximum).
    6. Attachments field – Drag and drop a file to attach or select the browse link to search for the file. The file name must not exceed 250 characters. For a list of supported file types, see What file types can I include in an attachment
  11. Select Close in the Close Incident [Incident ID] panel.
  12. Select Close in the confirmation dialog.

    The incident is closed by changing the Status to Closed.

If an incident is closed accidentally or the incident needs additional work after closing, a user can reopen the incident.

  1. Select a [Customer-defined APT Network] from the network drop-down in the header.
  2. Select a Team (e.g. your entire company or a Link to a specific Partner or internal location) in the header.
  3. Select the Compliance Exception Process in the header.
  4. Select the Go button in the header.
  5. Click Search in the Do menu.
  6. Filter to find the incident.
  7. Select the Action icon in the row for the incident.
  8. Select View Incident.
  9. Select Under Investigation from the Status drop-down in the top right of the screen.

  10. Fill in the following fields in the Reopen Incident [Incident ID] panel:

    • Comments field – Captures any comments about reopening the incident (5000 characters maximum).
    • Attachments field – Drag and drop a file to attach or select the browse link to search for the file. The file name must not exceed 250 characters. For a list of supported file types, see What file types can I include in an attachment

  11. Select Reopen in the Reopen Compliance Exception [Exception ID] panel.

    The incident is reopened by changing the Status to Under Investigation.

Monitor ongoing compliance exceptions

Monitor compliance exceptions at a high level to understand the state of all compliance exceptions that you have access to. For example, quality compliance managers might need to investigate the number of compliance exceptions that have been reported in the last 6 months.

  1. Select a [Customer-defined APT Network] from the network drop-down in the header.
  2. Select a Team (e.g. your entire company or a Link to a specific Partner or internal location) in the header.
  3. Select the Compliance Exception Process in the header.
  4. Select the Go button in the header.

    The dashboard has two tabs – Overview and Pending Actions. View the cards in each tab on the dashboard, which display pre-defined queries to demonstrate the state of all compliance exceptions at a high level. The labels on each card in the dashboard display a value as a link to the right. When selected, this link displays the table view of the compliance exceptions, filtered to the selected value. For example, if the value for Critical Incidents is selected, the table view displays with a filter applied to show only compliance exceptions with a Priority of Critical.

A summary of all compliance exceptions for the Network and Team selected in the header. A horizontal bar chart displays on this card with the following values, based on whether the user is assigned a role with expanded or standard access:

  • Total Open Incidents – The number of compliance exceptions with a Status of To Do or Under Investigation.
  • Critical Incidents – The number of compliance exceptions with a Priority of Critical.
  • No Activity This Week – The number of compliance exceptions that have not been updated in the last 7 days.
  • Closed This Week – The number of compliance exceptions that have been closed in the last 7 days.
  • Total Assigned To Me – The number of compliance exceptions that are currently assigned to the user.
  • Critical Incidents – The number of compliance exceptions with a Priority of Critical.
  • No Activity This Week – The number of compliance exceptions that have not been updated in the last 7 days.
  • Closed This Week – The number of compliance exceptions that have been closed in the last 7 days.

A summary of compliance exceptions for the Network and Team selected in the header based on their Incident Category. A list of the 4 most frequent incident categories among open compliance exceptions display on this card. 4 of the following values display:

  • Data Issues – The number of compliance exceptions with an Incident Category of Data Issues.
  • Damaged Product – The number of compliance exceptions with an Incident Category of Damaged Product.
  • Product But No Data – The number of compliance exceptions with an Incident Category of Product But No Data.
  • Data But No Product – The number of compliance exceptions with an Incident Category of Data But No Product.
  • Packaging – The number of compliance exceptions with an Incident Category of Packaging.
  • Product Hold – The number of compliance exceptions with an Incident Category of Product Hold.
  • Suspect Product – The number of compliance exceptions with an Incident Category of Suspect Product.
  • Misalignment – The number of compliance exceptions with an Incident Category of Misalignment.
  • Tracing/Verification – The number of compliance exceptions with an Incident Category of Tracing/Verification.
  • Other – The number of compliance exceptions with an Incident Category of Other.

A summary of compliance exceptions for the Network and Team selected in the header based on their Product Name. A list of the 4 most frequent products among open compliance exceptions display on this card.

A summary of all compliance exceptions for the Network and Team selected in the header based on their Priority. A list displays on this card with the following values:

  • Critical – The number of compliance exceptions with a Priority of Critical.
  • High – The number of compliance exceptions with a Priority of High.
  • Medium – The number of compliance exceptions with a Priority of Medium.
  • Low – The number of compliance exceptions with a Priority of Low.

A summary of all compliance exceptions for the Network and Team selected in the header based on their Status. A horizontal bar chart displays on this card with the following values:

  • To Do – The number of compliance exceptions with a Status of To Do.
  • In Review – The number of compliance exceptions with a Status of Under Investigation.

Displays only for Full Access users from the Owner if the Process is Compliance Exceptions. A view of all compliance exceptions for the Network and Team selected in the header based on the Partners or locations associated with the highest number of compliance exceptions with a Status of To Do or Under Investigation. A list displays on this card with the 5 entities that have the most open compliance exceptions.

A view of all compliance exceptions for the Network, Team, and Process selected in the header based on the last time they were updated. A list displays on this card with the following values:

  • Yesterday – The number of compliance exceptions that have been updated in the last 24 hours.
  • This Week – The number of compliance exceptions that have been updated in the last 7 days.
  • Last Week – The number of compliance exceptions that have been updated in the last 7 to 14 days.
  • More than 2 Weeks – The number of compliance exceptions been updated in more than 14 days ago.

. A summary of all compliance exceptions for the Network and Team selected in the header based on their Resolution Due Date. A horizontal bar chart displays on this card with the following values:

  • Past Due – The number of incidents that have not yet been closed with a due date prior to the current date.
  • This Week – The number of incidents that have not yet been closed and are due within the next 7 days.
  • Next Week – The number of incidents that have not yet been closed and are due in the next 7 to 14 days.
  • In 2 or More Weeks – The number of incidents that have not yet been closed and are due in more than 14 days.
  1. Select a [Customer-defined APT Network] from the network drop-down in the header.
  2. Select a Team (e.g. your entire company or a Link to a specific Partner or internal location) in the header.
  3. Select the Compliance Exception Process in the header.
  4. Select the Go button in the header.
  5. Click Search in the Do menu.
  6. Fill in one or more of the following fields to filter the results:

    • Exception ID field – The incident’s unique identifier.

    • Accountable Entity field – The name and identifier of the Partner company or location associated with the incident.

    • Status drop-down – The status of the incident:
      • To Do – Indicates that the incident is ready for review.
      • Under Investigation – Indicates that the incident has been created, reviewed, and submitted for investigation.
      • Closed – Indicates that the incident is closed.

    • Keyword field – A keyword which can be specified to retrieve results that include the specified keyword. The Keyword filter for Compliance Exceptions searches for matching entries against the Exception ID, Summary, Description, Incident Category, Incident Sub-Category, Serial Numbers, and Lot Numbers fields.

  7. Select Show Additional Filters and fill in one or more of the following fields to further filter the results:

    • Priority drop-down – The urgency with which the issue must be resolved:
      • Low – The incident is low priority.
      • Medium – The incident is medium priority.
      • High – The incident is high priority.
      • Critical – The incident is critical.
    • Product field – The product's name or identifier.
    • Current Assignees at Reporter Company field – The users at the company that is accountable for the incident and is responsible for taking action to resolve the incident.
    • Responsible User at Reporter Company field – The person from the company that is accountable for the incident and is responsible for the incident's resolution.

    • Responsible Department at Reporter Company field – The business area of the company, company location, Partner company, or Partner company location responsible for the incident's resolution:

      • Business Development – The user responsible for resolving the incident is part of a Business Development team.
      • Clinical Research – The user responsible for resolving the incident is part of a Clinical Research team.
      • Contract Management – The user responsible for resolving the incident is part of a Contract Management team.
      • Corporate Management – The user responsible for resolving the incident is part of a Corporate Management team.
      • Customer Service – The user responsible for resolving the incident is part of a Customer Service team.
      • Engineering – The user responsible for resolving the incident is part of an Engineering team.
      • Information Technology – The user responsible for resolving the incident is part of an Information Technology (IT) team.
      • Operations – The user responsible for resolving the incident is part of an Operations team.
      • Packaging – The user responsible for resolving the incident is part of a Packaging team.
      • Production or Manufacturing – The user responsible for resolving the incident is part of a Production team or Manufacturing team.
      • Project Management –The user responsible for resolving the incident is part of a Project Management team.
      • Purchasing – The user responsible for resolving the incident is part of a Purchasing team.
      • Quality Assurance, Control, or Validation – The user responsible for resolving the incident is part of a Quality Assurance (QA) team, Control team, or Validation team.
      • Research, Development, or Formulation – The user responsible for resolving the incident is part of a Research team, Development team, or Formulation team.
      • Sales or Marketing – The user responsible for resolving the incident is part of a Sales team or Marketing team.
      • Supply Chain – The user responsible for resolving the incident is part of a Supply Chain team.
      • Retail – The user responsible for resolving the incident is part of the Retail team.
      • Omnicare – The user responsible for resolving the incident is part of the Omnicare team.
      • Minute Clinic – The user responsible for resolving the incident is part of the Minute Clinic team.
      • Vanguard – The user responsible for resolving the incident is part of the Vanguard team.
      • Specialty Pharmacy / CarePlus – The user responsible for resolving the incident is part of the Specialty Pharmacy or CarePlus team.
      • Distribution Centers – The user responsible for resolving the incident is part of the Distribution Centers team.
      • PBM Mail Order – The user responsible for resolving the incident is part of the PBM Mail Order team.
      • PBM Specialty Mail – The user responsible for resolving the incident is part of the PBM Specialty Mail team.
      • Specialty Wholesale – The user responsible for resolving the incident is part of the Specialty Wholesale team.
      • Coram – The user responsible for resolving the incident is part of the Coram team.
    • Accountable Entity field – The name and identifier of the company, company location, Partner company, or Partner company location that the incident is being submitted to.

    • Resolution Type field – The reason why the incident was closed:

      • Resolved – The problem that caused the incident is resolved.
      • Duplicate – An incident for the problem already exists.
      • Not an Issue – The incident was created in error and the investigation determined there was not actually a problem.
      • Other Resolution Type – The user entered final outcome of the incident.
    • Disposition Type field - The product action taken as a result of the incident:
      • Approve (release) – The compliance exception is within acceptable business standards, the product is approved for release.
      • Reject (OV return) – The compliance exception is not within acceptable business standards, the product is returned to an outside vendor.
      • Reject (NSR return) – The compliance exception is not within acceptable business standards, the product is returned as non-saleable.
      • Reject (other) – The compliance exception is not within acceptable business standards, the product is returned for an unspecified reason.
    • Date Closed field – The date the incident was closed on.

    •  Incident Category drop-down – The primary cause of the incident:

      • Data Issues – The product's data is incomplete or incorrect.
      • Damaged Product – The product was damaged during the packing, transportation, or filling process. This includes breakage, scratches, or particles resulting from damage.
      • Product But No Data – The product was received without the required supporting product details (e.g. lot number information).
      • Data But No Product – A product's details were received without also receiving the physical product.
      • Packaging – The product's packaging is inadequate or contains incorrect information, such as dosage or usage information.
      • Product Hold – The product's shipment was delayed or suspended due to quality concerns, safety issues, regulatory compliance, or other reasons.
      • Suspect Product – The product is believed to be potentially counterfeit, diverted, stolen, intentionally adulterated, the subject of a fraudulent transaction, or appears otherwise unfit for distribution.
      • Misalignment – There is a discrepancy between supply chain partners about the product (e.g. product specifications).
      • Tracing/Verification – The product's history cannot be properly traced or verified.
      • Other – The incident is caused by a user-defined problem.
    • Resolution Due Date field – The date that the incident must be closed by.
  8. Select Apply.

    The filtered results display in the table.

From the filtered results, if you open a compliance exception and then navigate back to the Search screen using the breadcrumb trail, the search filters applied are retained.
  1. Select a [Customer-defined APT Network] from the network drop-down in the header.
  2. Select a Team (e.g. your entire company or a Link to a specific Partner or internal location) in the header.
  3. Select the Compliance Exception Process in the header.
  4. Select the Go button in the header.
  5. Click Search in the Do menu.
  6. Filter to find the incident.
  7. Select the Action icon in the row for the incident.
  8. Select Follow or Unfollow.

    If you are currently not  following the incident, you begin following the incident. If you are currently following the incident, you stop following the incident.

  1. Select a [Customer-defined APT Network] from the network drop-down in the header.
  2. Select a Team (e.g. your entire company or a Link to a specific Partner or internal location) in the header.
  3. Select the Compliance Exception Process in the header.
  4. Select the Go button in the header.
  5. Click Search in the Do menu.
  6. Filter to find the incident.
  7. Select the Action icon in the row for the incident.
  8. Select View Activity.

    View the previous actions taken on the incident, as well as who took the action and when.