Equipment Qualification

1. Title field – Enter a clear and descriptive title for the equipment qualification.
2. Description field – Enter a brief description of the reason, scope, or trigger for the equipment qualification.

In the General section update the following fields:

1. Display Identifier field – Select system-generated identifier for the Equipment Qualification; format EQ-0001 with configurable prefix.
2. Title field – Enter the title of the Equipment Qualification.
3. Business Priority field – Select business priority: Critical, High, Medium, or Low.
4. Functional Area field – Select department or business function associated with the equipment qualification.
5. Due Date field – Select due date for the Equipment Qualification.
6. Description field – Enter the overview of the equipment qualification request; provide detailed background and intent.

In the Equipment Details section update the following fields:

1. Equipment Name field – Enter the name of the equipment being qualified.
2. Equipment ID field – Enter the unique equipment identifier used for traceability.
3. Equipment Type field – Select type or category of equipment associated with the qualification.
4. Other Equipment Type field – Enter the specify the equipment type when Equipment Type is Other.
5. Manufacturer field – Enter the manufacturer of the equipment.
6. Equipment Model Number field – Enter the equipment model number.
7. Serial Number field – Enter the manufacturer serial number for the equipment.
8. Equipment Location field – Enter the facility, room, zone, or location where the equipment is installed or used.
9. Intended Use field – Enter the describe the intended GMP use of the equipment.
10. GMP Impact field – Select gMP impact classification: Direct Impact, Indirect Impact, No Impact, or Not Assessed.
11. Equipment Criticality field – Select indicates whether the equipment is critical to product quality, patient safety, data integrity, or GMP operations.

In the Participants section update the following fields:

1. Initiator Company Business Name field – Select business name of the Initiator Company.
2. Initiator Company Identifier Type field – Select identifier type of the Initiator Company.
3. Initiator Company Identifier Value field – Select identifier value of the Initiator Company.
4. Assignee Company Business Name field – Select business name of the Assignee Company.
5. Assignee Company Identifier Type field – Select identifier type of the Assignee Company.
6. Assignee Company Identifier Value field – Select identifier value of the Assignee Company.
7. Assignee User Email field – Select email address of the person to whom the Equipment Qualification is currently assigned.
8. Assignee User Name field – Select name of the person to whom the Equipment Qualification is currently assigned.
9. Owner Qualification Lead Email field – Select email of the primary qualification owner from the Owner Company.
10. Owner Qualification Lead Name field – Select name of the primary qualification owner from the Owner Company.
11. Partner Qualification Lead Email field – Select email of the primary qualification partner from the Partner Company.
12. Partner Qualification Lead Name field – Select name of the primary qualification partner from the Partner Company.

In the Intended Use and Design Requirements section update the following fields:

1. User Requirements Summary field – Enter the summarize user requirements, process needs, functional expectations, and quality requirements.
2. Functional Expectations field – Enter the describe expected equipment functions, operating ranges, process capabilities, and user interactions.
3. Design Expectations field – Enter the describe design expectations, materials, configuration, utilities, interfaces, and controls.
4. Controls and Alarms Required field – Enter the identify required controls, alarms, interlocks, setpoints, limits, and displays.

In the Operational and Lifecycle Requirements section update the following fields:

1. Calibration Points Identified field – Enter the identify instruments, sensors, measurement points, and calibration expectations.
2. Maintenance Requirements Identified field – Enter the identify preventive maintenance, spare parts, service requirements, and routine checks.
3. Cleaning and Contamination Considerations field – Enter the describe cleaning, contamination control, material compatibility, or carryover considerations.

In the Quality and Risk Assessment section update the following fields:

1. Data Integrity Assessment field – Enter the describe data integrity risks, records, audit trails, security, access controls, and backup expectations.
2. Equipment-Related Risk Assessment field – Enter the assess product quality, patient safety, data integrity, cleaning, contamination, utility, and operational risks.

In the Design Review and Conclusion section update the following fields:

1. Supplier Specifications Reviewed field – Select confirm supplier specifications, drawings, manuals, certificates, and technical information have been reviewed.
2. Design Gaps or Requirement Conflicts field – Enter the document design gaps, requirement conflicts, open questions, and required resolutions.
3. Design Suitability Conclusion field – Enter the document the conclusion that equipment design is suitable for intended use.
4. Requirements and Design Attachment field – Select upload URS, design review, supplier specification, drawings, manuals, risk assessment, or technical records.

In the Scope Details section update the following fields:

1. Qualification Scope Summary field – Enter the describe the equipment, intended use, operating environment, and scope of qualification.
2. Product Impact field – Select identify whether equipment may affect product quality.
3. Process Impact field – Select identify whether equipment may affect process execution or process control.
4. Data Impact field – Select identify whether equipment impacts regulated data or data integrity.
5. Regulatory Expectations field – Select applicable regulatory standards associated with the qualification.
6. Applicable Procedures and Standards field – Enter the identify SOPs, standards, validation procedures, quality procedures, and site requirements.
7. Plan and Scope field – Select upload the qualification plan, scope document, role alignment document, or planning checklist.

In the Installation Review - Site readiness section update the following fields:

1. Equipment Received field – Select confirm equipment has been received.
2. Equipment Identification Verified field – Select confirm equipment name, ID, model, serial number, and tag are verified.
3. Installation Location Verified field – Select confirm installation location matches approved requirements.
4. Utilities Verified field – Select confirm required utilities are available and connected.
5. Environmental Conditions Verified field – Select confirm environmental requirements are met.
6. Components Verified field – Select confirm required components, accessories, and assemblies are present.
7. Manuals and Drawings Available field – Select confirm manuals, drawings, and supporting technical documentation are available.
8. Certificates Available field – Select confirm certificates, material documentation, or supplier records are available.

In the Installation Review - System Sign Off section update the following fields:

1. Instruments Verified field – Select confirm required instruments and measurement devices are installed.
2. Connections Verified field – Select confirm mechanical, electrical, network, utility, and process connections are verified.
3. Critical Instruments Calibrated field – Select confirm critical instruments are calibrated and traceable to approved standards.
4. Safety Features Verified field – Select confirm guards, stops, alarms, labels, safety features, and interlocks are installed where applicable.
5. Installation Discrepancies field – Enter the describe installation-related discrepancies and their resolution status.
6. Installation Verification Conclusion field – Enter the summarize installation verification results and readiness for operational testing.
7. Installation Verification Attachment field – Select upload installation checklist, IQ protocol, installation report, calibration certificates, photos, drawings, or discrepancy records.

In the Operational Review - Functional Testing section update the following fields:

1. Operational Verification Protocol field – Select upload the approved operational verification protocol or test script.
2. Functional Conditions Tested field – Select confirm expected functions were tested.
3. Operating Ranges Tested field – Select confirm equipment was tested across defined operating ranges.
4. Setpoints Verified field – Select confirm setpoints and tolerances were verified.
5. Sequences Tested field – Select confirm operational sequences were tested.
6. Displays Verified field – Select confirm displays, indicators, and user interfaces were verified.
7. Automation / Software Verified field – Select confirm automation, software, user access, records, security, and data integrity expectations were verified when applicable.

In the Operational Review - Exception testing section update the following fields:

1. Controls Challenged field – Select confirm controls were challenged as applicable.
2. Alarms Challenged field – Select confirm alarms were challenged as applicable.
3. Interlocks Challenged field – Select confirm interlocks were challenged as applicable.
4. Boundary Conditions Tested field – Select confirm operating limits and boundary conditions were tested where applicable.
5. Failure Responses Tested field – Select confirm equipment response to failures or abnormal conditions was tested where applicable.
6. Operational Verification Result field – Select operational verification outcome: Pass, Pass with Open Items, Fail, or Not Executed.
7. Operational Deviations field – Enter the document operational test deviations, discrepancies, troubleshooting, and resolutions.
8. Operational Verification Conclusion field – Enter the summarize operational verification results and readiness for performance confirmation.
9. Operational Verification Attachment field – Select upload OQ protocol, test results, screenshots, automation evidence, deviation records, or troubleshooting evidence.

In the Performance Review section update the following fields:

1. Performance Confirmation Protocol field – Select upload the approved performance confirmation or PQ protocol.
2. Intended Use Conditions Confirmed field – Select confirm testing was performed under actual or representative intended-use conditions.
3. Trained Personnel Used field – Select confirm trained personnel executed or supported performance activities.
4. Approved Procedures Used field – Select confirm approved procedures were used during performance confirmation.
5. Appropriate Materials Used field – Select confirm appropriate materials, samples, product, media, or representative materials were used.
6. Acceptance Criteria Defined field – Select confirm approved performance acceptance criteria were defined before execution.
7. Critical Parameters Monitored field – Select confirm critical process, product, equipment, environmental, or output parameters were monitored.
8. Performance Results Summary field – Enter the summarize performance results and evidence.
9. Performance Deviations field – Enter the document deviations, investigations, conclusions, and follow-up actions.
10. Performance Confirmation Result field – Select performance confirmation outcome: Pass, Pass with Open Items, Fail, or Not Executed.
11. Procedure Readiness Confirmed field – Select confirm procedures are ready for routine operation.
12. Training Readiness Confirmed field – Select confirm routine operation training is ready or complete.
13. Maintenance Readiness Confirmed field – Select confirm the maintenance plan is ready for routine operation.
14. Calibration Readiness Confirmed field – Select confirm the calibration program is ready for routine operation.
15. Performance Confirmation Conclusion field – Enter the summarize whether performance evidence demonstrates suitability for routine GMP use.
16. Performance Confirmation Attachment field – Select upload PQ protocol, performance results, trend data, run records, parameter reports, deviation records, or approval evidence.

In the Closure Summary section update the following fields:

1. Closure Status field – Select final qualification outcome: Qualified, Qualified with Conditions, Not Qualified, or Withdrawn.
2. Next Review Date field – Select date on which the equipment qualification should be reviewed again.
3. Closure Notes field – Enter the final remarks and sign-off summary.
4. Qualification Review and Release Attachment field – Select upload the final qualification report, traceability matrix, deviation summary, approval evidence, release memo, or GMP release record.
5. Date Closed field – Select auto-populated date and time when the record is closed.
6. Closed By field – Select auto-populated user who transitions the record to Closed.

In the Filters panel, fill in one or more of the following fields to filter the results:

1. Display ID field – Display Identifier of the Equipment Qualification can be used for search.
2. Title field – Allows the user to search with complete or part of the title string.
3. State field – Workflow state of the Equipment Qualification: Draft, To Do, In Progress, or Done; customized substates are available through the derived currentState field.
4. Creation Time field – Timestamp when the Equipment Qualification was created.
5. Initiator Company field – Search by business name and identifier.
6. Assignee Company field – Search by business name and identifier.
7. Due Date field – Filter by target completion date.
8. Equipment Name field – Search by equipment name.
9. Equipment ID field – Search by equipment identifier.
10. Equipment Type field – Filter by equipment type.
11. Business Priority field – Search by business priority.
12. Last Modified field – Timestamp when the Equipment Qualification was last modified.

Select Apply.
All Equipment Qualifications matching the filter criteria are displayed.