POET is not designed to serve as the system of record for regulated processes, therefore not subject to GxP requirements. It is designed to enable cross-organizational collaboration and process orchestration, while the system of record for each process remains within the respective enterprise systems.

Type = Technical Guides,; Topic = OPUS Solution Environment, Process Orchestration for Empowered Teams (POET), OPUS,;Persona = Solution Designer, Solution Partner, Technology Partner,; Orchestration = Logistics,; Function = Regulatory Affairs, Quality,

Site Readiness Assessments

Site Readiness Assessments enable pharmaceutical companies to initiate and manage structured readiness inspections or assessments for internal and external supply chain sites. The solution supports collaboration, evidence review, gap tracking, remediation, validation, and formal readiness completion.

What is a site readiness assessment

A Site Readiness Assessment is a structured process used to evaluate whether a supply chain site is operationally, regulatorily, and commercially ready before activation or release. Site Readiness Assessment records allow teams to capture scope, participants, assessment evidence, reporting outcomes, remediation details, and closure decisions.

The Site Readiness Assessment process typically includes the following steps:

  1. Initiation - A Site Readiness Assessment record is created in Draft state.
  2. Planning - Scope, stakeholders, dates, business priority, and site information are finalized.
  3. Site Assessment - Required documents and onsite or remote assessment details are reviewed.
  4. Reporting and Gap Analysis - Assessment results, identified gaps, and remediation requirements are documented.
  5. Remediation and Rectification - Corrective actions, rectification evidence, and validation notes are captured.
  6. Closure - The final readiness status is selected and the assessment is formally completed or canceled.

Types of site readiness assessments

  • Remote Assessment - A readiness assessment performed remotely using submitted documentation and supporting evidence.

  • Onsite Assessment - A readiness assessment performed at the site being evaluated.

  • Hybrid Assessment - A readiness assessment that includes both remote document review and onsite evaluation activities.

How to configure the site readiness assessment marketplace solution

Before using the Site Readiness Assessment marketplace solution, Solution Designers must first configure the solution in OPUS Solution Environment (OSE) by completing the following steps:

Solution Designers must first save the latest version of the marketplace solution from the marketplace catalog as a company solution.

  1. Select the Main Menu icon.
  2. Select OPUS Solution Environment.
  3. Select Catalog from the left menu.
  4. Select Marketplace Solutions.
  5. On the Search Solutions page, filter the list of solutions to find the required solution.
  6. Find the latest version of the solution and select the Solution Name to open the solution.
  7. On the Solution Details page, select Save As.
  8. On the Save As panel, fill in the following fields:
    1. Solution Name field – The name of the solution that will be saved as a company solution.
    2. Description field – (Optional) The description of the solution.
  9. Select Apply.
    The marketplace will be saved as a company solution in the Available tab on the left menu.

After saving the solution as a Company Solution, Solution designers must create a network for the solution from OPUS Administration.

  1. Select the Main Menu icon.
  2. Select Administration.
  3. Select Network and Apps from the left menu.
  4. Select New.
  5. In the Network Information section, fill in the following fields:
    1. Application drop-down – Select the application for which you want to configure the marketplace solution. For e.g. Process Orchestration for Empowered Teams.
    2. Network Name field – The name of the network being created.
    3. Network Description field – (Optional) The description of the network being created.
  6. In the Solution section, fill in the following fields:
    1. Standard Solution toggle – This value must be no as the solution for which the network is being created is a marketplace solution.
    2. Company Solution field – Select the solution that you saved as a company solution in the previous procedure.
  7. Select Save.
    The new network is created and the solution is ready for use.

After creating a network for the solution, Solution Designers must define roles for accessing the network.

  1. Select the Main Menu icon.
  2. Select Administration.
  3. Select Users from the left menu.
  4. Select Network Members from the left menu.
  5. On the Search Network Members page, filter the list of network members by the network created in the previous procedure.
  6. Select the user email of the user who created the network.
  7. Select Edit.
  8. In the Roles section, select the role required to access the network.
  9. Select Save.
    The role to access the new network is configured.

Add a site readiness assessment

Add a site readiness assessment by entering the required details.

  1. Select the Main Menu icon.
  2. Select My Networks.
  3. Select a [POET Network] from the Select your Network drop-down in the header.
  4. Select a Partner or location from the Select your Partner or Location drop-down in the header.
  5. Select Go.
  6. Select Site Readiness Assessments from the left menu.
  7. Select New.
  8. In the General section fill in the following fields:
    1. Title field – The readiness title. This field is required.
    2. Description field – A summary of the Site Readiness Assessment record, including site context, readiness purpose, and background.
  9. Select Save.
    The Site Readiness Assessment is created in the Draft state.

Modify a site readiness assessment

Modify an existing site readiness assessment by updating the required details.

  1. Select the Main Menu icon.
  2. Select My Networks.
  3. Select a [POET Network] from the Select your Network drop-down in the header.
  4. Select a Partner or location from the Select your Partner or Location drop-down in the header.
  5. Select Go.
  6. Select Site Readiness Assessments from the left menu.
  7. Select the Display Identifier of the Site Readiness Assessment to edit.
  8. Select Edit.
  9. In the General section update the following fields:
    1. Business Impact field – Indicates whether the Site Readiness Assessment has business impact.
    2. Business Priority field – Business urgency. Select from Critical, High, Medium, or Low.
    3. Description field – Background context for the Site Readiness Assessment.
    4. Display Identifier field – The system-generated unique identifier for the Site Readiness Assessment record.
    5. Due Date field – The target completion date. This field is required.
    6. Planned End Date field – The target completion date. The planned end date must be on or after the planned start date.
    7. Planned Start Date field – The planned assessment start date. The date cannot be in the past.
    8. Site Readiness Reason field – The reason for the assessment. Select from Audit and Inspection Finding, Business Continuity and Risk Mitigation, Capacity Expansion, Certification Renewal and Expiry, Logistics Network Change, Manufacturing and Process Change, New Product Introduction, New Site, Partner Onboarding, Periodic Requalification, Regulatory and Market Expansion, Technology Transfer, or Other.
    9. Title field – The readiness title. This field is required.
  10. In the Participants section update the following fields:
    1. Assessment Coordinator Email field – The email for the assessment coordinator.
    2. Assessment Coordinator Name field – The name of the assessment coordinator.
    3. Assignee Company Business Name field – The business name of the assignee company.
    4. Assignee Company Identifier Type field – The identifier type of the assignee company.
    5. Assignee Company Identifier Value field – The identifier value of the assignee company.
    6. Assignee User Email field – The email for the assignee user.
    7. Assignee User Name field – The name of the assignee user.
    8. Initiator Company Business Name field – The business name of the initiator company.
    9. Initiator Company Identifier Type field – The identifier type of the initiating company.
    10. Initiator Company Identifier Value field – The identifier value of the initiating company.
    11. Site Lead Email field – The email for the site lead.
    12. Site Lead Name field – The name of the site lead.
  11. In the Assessment Scope section update the following fields:
    1. Assessment Acceptance Criteria field – The evaluation standards for the assessment.
    2. Assessment Success Criteria field – The minimum conditions required to consider the Site Readiness Assessment successful.
    3. Assessment Type field – The type of assessment. Select from Remote, Onsite, or Hybrid.
    4. Operational Scope field – The assessed areas and scope summary.
    5. Primary Site field – The functional classification of the site. This field is required.
    6. Regulatory Impact field – Indicates whether the assessment has regulatory impact.
    7. Secondary Site field – The functional site type based on the selected primary site.
  12. In the Site Assessment section update the following fields:
    1. Areas Assessed field – The areas reviewed during the assessment. This should align with the operational scope.
    2. Document Assessment Summary field – The summary of documents submitted for assessment. This is editable by the Partner only in the Assessment state.
    3. Document Submission Date field – The date documents were submitted. This field is auto-populated on submission.
    4. List of Documents field – Documentation evidence required for assessment.
    5. Onsite Assessment Summary field – The summary of site assessment observations. This is editable by the Owner only in the Assessment state.
    6. Overall Assessment Lead field – The Owner or assessment lead preparing the combined summary.
    7. Overall Assessment Summary field – The summary of document and onsite assessment results. This is editable by the Owner in the Assessment state.
    8. Readiness Observations field – Observations for facility or infrastructure, equipment or system, personnel or training, quality or compliance, and operational readiness.
    9. Report Due Date field – The report due date.
    10. Scheduled On Date field – The date of the onsite assessment. This is required if the assessment type is Onsite or Hybrid.
    11. Supporting Documents field – Supporting documents for the document assessment or onsite assessment.
  13. In the Reporting and Gap Analysis section update the following fields:
    1. Assessment Report Summary field – The summary of the assessment outcome. This is editable by the Owner in the Assessment state.
    2. Gap Analysis Report field – The supporting assessment or gap analysis report.
    3. Gap Analysis Summary field – The consolidated summary of gaps from document validation and onsite assessment.
    4. Gap Category field – The type of gaps identified. Select from Data Integrity, Documentation, Equipment, Facility, Process, Quality, Regulatory, Storage, Temperature Control, System, Training, or Other.
    5. Overall Assessment Report field – The overall assessment report attachment.
    6. Remediation Due Date field – The target date for remediation completion. This is required if remediation is required.
    7. Remediation Required field – Indicates whether remediation must be performed. This defaults to Yes if gaps are identified.
    8. Report Prepared By field – The Owner or assessment lead responsible for the assessment report.
  14. In the Site Remediation and Rectification section update the following fields:
    1. QA Validation Notes field – Validation remarks. This field is editable by QA only.
    2. Rectification Completion Date field – The completion date for rectification. This date cannot exceed the closure date.
    3. Rectification Evidence field – Proof uploaded by the Partner.
    4. Rectification Summary field – The summary of corrective actions entered by the Partner.
    5. Remediation Completion Date field – The completion date for remediation. This date cannot exceed the closure date.
    6. Remediation Summary field – The summary of corrective actions.
    7. Remediation Type field – The type of remediation suggested. Select from CAPA, Change Request, License Review, Risk Assessment, SOP, or Others.
    8. Supporting Document field – Supporting documentation.
  15. In the Site Readiness Closure section update the following fields:
    1. Closed By field – The responsible approver. This field is for the Owner only.
    2. Closure Report field – The formal closure document.
    3. Closure Summary field – The final summary. This is editable in the Closure Review state.
    4. Date Closed field – The formal closure date. This field is auto-populated on transition to Closed.
    5. Final Readiness Status field – The final determination. Select from Site Ready, Ready with Minor Findings, or Not Ready. This field is required.
  16. In the Comments and Attachments section update the following fields:
    1. Attachments field – Files attached to the comment.
    2. Comment field – The text of the comment.
    3. Comment Author field – The user name of the user who entered the comment.
    4. Last Modified field – The date and time when the comment was last modified.
  17. In the Followers section review the following fields:
    1. Followers field – The list of users who follow the Site Readiness Assessment.
  18. Select Save.

Workflow

The workflow defines the lifecycle of a Site Readiness Assessment record from creation to completion. Each state represents a stage in the collaboration process between Owner and Partner organizations.

Base State Workflow State Description
Draft Draft Site Readiness is being authored.
To Do Planning Scope and stakeholders are finalized and readiness planning is initiated.
In Progress Site Assessment Site evaluation and gap identification are underway.
In Progress Reporting and Gap Analysis Assessment reporting and gap analysis are performed.
In Progress Remediation and Rectification Identified gaps are being addressed.
Done Completed Site Readiness is formally concluded.
Done Canceled The readiness program is discontinued.

Monitor site readiness assessments

Monitor site readiness assessment records using dashboards and search to track progress, monitor key activities, and analyze performance.

  1. Select the Main Menu icon.
  2. Select My Networks.
  3. Select a [POET Network] from the Select your Network drop-down in the header.
  4. Select a Partner or location from the Select your Partner or Location drop-down in the header.
  5. Select Go.
  6. Select Site Readiness Assessment.
  7. Select Dashboards.
Metric Description
Current Trends
Site Readiness Assessments by Status – Open Total number of Site Readiness Assessments categorized by Status, such as Draft, To Do, In Progress, Assessment, Remediation, Rectification, Closure Review, etc.
Site Readiness Assessments by Business Priority Number of Site Readiness Assessments of Status Draft, To Do, In Progress, or other open states categorized by Business Priority: Critical, High, Medium, Low.
Site Readiness Assessments by Site Readiness Reason Number of Site Readiness Assessments categorized by Site Readiness Reason, such as New Site, Partner Onboarding, Capacity Expansion, Regulatory and Market Expansion, Technology Transfer, etc.
Site Readiness Assessments by Primary Site Number of Site Readiness Assessments categorized by Primary Site, such as Manufacturing Sites, Storage & Distribution Sites, Supplier Sites, Quality & Testing Sites, etc.
Site Readiness Assessments by Assessment Type Number of Site Readiness Assessments categorized by Assessment Type: Remote, Onsite, Hybrid.
Due Date Monitoring
Site Readiness Assessments Overdue Total number of Site Readiness Assessments with Due Date less than the current date/time categorized by Status.
Site Readiness Assessments Due in Next 24 Hours Total number of Site Readiness Assessments with Due Date within the next 24 hours categorized by Status.
Site Readiness Assessments Due in Next 7 Days Total number of Site Readiness Assessments with Due Date within the next 7 days from the current date categorized by Status.
Site Readiness Assessments Due in Future Total number of Site Readiness Assessments with Due Date greater than 7 days from the current date categorized by Status.
Network Performance
Site Readiness Assessments by Assignee Company Total number of Site Readiness Assessments categorized by Assignee Company and Status.
Site Readiness Assessments by Assessment Coordinator Total number of Site Readiness Assessments categorized by Assessment Coordinator and Status.
Site Readiness Assessments by Site Lead Total number of Site Readiness Assessments categorized by Site Lead and Status.
Organizational Performance
Site Readiness Assessments by Final Readiness Status Total number of Site Readiness Assessments in Closed state categorized by Final Readiness Status: Site Ready, Ready with Minor Findings, Not Ready.
Average Time to Close Site Readiness Assessments by Final Readiness Status Average duration from creation to Date Closed categorized by Final Readiness Status.
Average Time to Close Site Readiness Assessments by Assessment Type Average duration from creation to Date Closed categorized by Assessment Type.
Site Readiness Assessment Reports Overdue Total number of Site Readiness Assessments where Report Due Date has passed and reporting is not yet completed.
  1. Select the Main Menu icon.
  2. Select My Networks.
  3. Select a [POET Network] from the Select your Network drop-down in the header.
  4. Select a Partner or location from the Select your Partner or Location drop-down in the header.
  5. Select Go.
  6. Select Site Readiness Assessment.
  7. Select Dashboards.
Metric Description
Current Trends
Site Readiness Assessments by Status – Open Total number of partner-assigned Site Readiness Assessments categorized by Status.
Site Readiness Assessments by Business Priority Number of partner-assigned Site Readiness Assessments categorized by Business Priority: Critical, High, Medium, Low.
Site Readiness Assessments by Site Readiness Reason Number of partner-assigned Site Readiness Assessments categorized by Site Readiness Reason.
Site Readiness Assessments by Primary Site Number of partner-assigned Site Readiness Assessments categorized by Primary Site.
Site Readiness Assessments by Assessment Type Number of partner-assigned Site Readiness Assessments categorized by Assessment Type.
Due Date Monitoring
Site Readiness Assessments Overdue Total number of partner-assigned Site Readiness Assessments with Due Date less than the current date/time categorized by Status.
Site Readiness Assessments Due in Next 24 Hours Total number of partner-assigned Site Readiness Assessments with Due Date within the next 24 hours categorized by Status.
Site Readiness Assessments Due in Next 7 Days Total number of partner-assigned Site Readiness Assessments with Due Date within the next 7 days categorized by Status.
Site Readiness Assessments Due in Future Total number of partner-assigned Site Readiness Assessments with Due Date greater than 7 days from the current date categorized by Status.
Network Performance
Site Readiness Assessments by Assignee User Total number of partner-assigned Site Readiness Assessments categorized by Assignee User and Status.
Site Readiness Assessments by Site Lead Total number of partner-assigned Site Readiness Assessments categorized by Site Lead and Status.
Organizational Performance
Site Readiness Assessments by Final Readiness Status Total number of closed partner-assigned Site Readiness Assessments categorized by Final Readiness Status: Site Ready, Ready with Minor Findings, Not Ready.
Site Readiness Assessment Reports Overdue Total number of Site Readiness Assessments where Report Due Date has passed and reporting is not yet completed.
Site Readiness Assessment Remediation Plans Overdue Total number of partner-assigned Site Readiness Assessments with overdue Remediation Due Date.
Average Time to Close Site Readiness Assessments by Final Readiness Status Average duration from creation to Date Closed categorized by Final Readiness Status.
Average Time to Close Site Readiness Assessments by Assessment Type Average duration from creation to Date Closed categorized by Assessment Type.
  1. Select the Main Menu icon.
  2. Select My Networks.
  3. Select a [POET Network] from the Select your Network drop-down in the header.
  4. Select a Partner or location from the Select your Partner or Location drop-down in the header.
  5. Select Go.
  6. Select Site Readiness Assessments from the left menu.
  7. Select Filter.

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

    1. Assignee Company field – Search by assessed company or partner.
    2. Business Priority field – Filter by business priority. Select from Critical, High, Medium, or Low.
    3. Display Identifier field – Search by Site Readiness Assessment ID.
    4. Due Date field – Filter by target completion date.
    5. Final Readiness Status field – Filter by final readiness status. Select from Site Ready, Ready with Minor Findings, or Not Ready.
    6. Initiator Company field – Search by owner company.
    7. Primary Site field – Filter by primary site. Select from Clinical & Research Sites, Logistics & Transportation Sites, Manufacturing Sites, Packaging & Labeling Sites, Quality & Testing Sites, Storage & Distribution Sites, or Supplier Sites.
    8. Site Readiness Reason field – Filter by readiness reason. Select from Audit / Inspection Finding, Business Continuity / Risk Mitigation, Capacity Expansion, Certification Renewal / Expiry, Logistics Network Change, Manufacturing / Process Change, New Product Introduction, New Site / Partner Onboarding, Periodic Requalification, Regulatory / Market Expansion, Technology Transfer, or Other.
    9. State field – Filter by derived current state. Select from Draft, To Do, In Progress, or Done.
    10. Title field – Search by partial or full title text.

  9. Select Apply.
    All Site Readiness Assessments matching the filter criteria are displayed.

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