Automated document control configuration for audit readiness in regulated environment

PLM Oracle Agile PLM
, , , , , , , ,
1

We recently implemented an automated document control system in Agile 9.3.4 to support our ISO 13485 and FDA 21 CFR Part 11 compliance requirements. The goal was to eliminate manual routing errors and ensure complete audit trails for all controlled documents. I wanted to share our implementation approach and results.

Our pharmaceutical device division was facing recurring audit findings related to document review completeness and approval timing. Manual routing meant reviewers were sometimes skipped, approval sequences weren’t always followed, and we had gaps in our audit trail documentation.

We configured automated document routing workflows using PX extensions to dynamically assign reviewers based on document type, affected products, and change impact. The system now automatically determines the review path and enforces sequential approval requirements.

// Simplified PX logic for dynamic reviewer assignment
String docType = document.getValue("Document_Type");
IUser[] reviewers = getReviewersByDocType(docType);
workflow.assignReviewers(reviewers);

The implementation took about 4 months including validation. We’re now seeing 100% review completion, average approval cycle reduced from 12 days to 6 days, and zero audit findings for document control in our last two regulatory inspections.

2

What document types are you managing through this system? We have technical documents, SOPs, work instructions, and validation protocols - each with different routing requirements. Did you create separate workflows for each type or use a single configurable workflow with conditional routing?

3

I’m curious about the PX implementation details. How do you determine which reviewers are required for each document type? Is this configured in lookup tables, or do you have more complex logic that considers multiple factors? Also, how do you handle situations where the routing rules need to change - can admins modify the reviewer assignment logic without code changes?

4

From a validation perspective, how did you approach qualifying this automated system for FDA compliance? Did you need to perform IQ/OQ/PQ, and how did you demonstrate that the PX logic correctly assigns reviewers in all scenarios? We’re considering a similar implementation but our validation team is concerned about the effort required to qualify custom code.

5

This is really impressive. How do you handle situations where a required reviewer is unavailable due to vacation or leave? Do you have an automatic escalation or substitute reviewer assignment built into the workflow?

6

The audit trail piece is critical for us too. Are you using Agile’s standard audit reporting or did you build custom reports to show the complete review and approval history? Our auditors want to see not just who approved, but when each person was notified, how long they took to respond, and any comments or rejections along the way.

7

Thanks for all the great questions. Let me provide a comprehensive overview of our implementation addressing the key focus areas:

Automated Document Routing Implementation: We implemented a single master workflow with conditional routing logic rather than separate workflows per document type. This reduces maintenance overhead and ensures consistent behavior. The workflow uses a decision matrix stored in custom tables within Agile:

Document_Type → Review_Roles_Required → Sequence_Order

For example:

  • SOP → Quality Manager → Regulatory Affairs → Department Head (sequential)
  • Work Instruction → Subject Matter Expert → Supervisor (parallel) → Quality (final)
  • Validation Protocol → Validation Engineer → Quality Engineer → QA Manager (sequential)

The PX logic queries these tables at workflow initiation and builds the routing path dynamically. Here’s the enhanced code structure:

// Enhanced reviewer assignment with escalation
String docType = document.getValue("Document_Type");
String[] impactedProducts = document.getAffectedProducts();

List<ReviewerAssignment> assignments = new ArrayList<>();
for (String role : getRequiredRoles(docType)) {
    IUser primary = getUserByRole(role, impactedProducts);
    IUser backup = getBackupUser(primary);
    assignments.add(new ReviewerAssignment(primary, backup, role));
}

workflow.setReviewSequence(assignments);
workflow.enableAutoEscalation(48); // hours

The routing configuration is maintained through Admin Console lookup tables, so business users can modify reviewer assignments without code changes. We created a custom “Reviewer Matrix” page class that provides a UI for managing the routing rules.

PX Reviewer Assignment Logic: Our reviewer assignment considers multiple factors:

  1. Document Type - primary routing determinant
  2. Affected Product Lines - assigns product-specific SMEs
  3. Change Impact Level - determines approval authority required
  4. Regulatory Scope - adds regulatory reviewers when applicable
  5. Document Classification - handles confidential/export controlled docs

The PX uses a weighted scoring algorithm to determine the minimal required review set while ensuring all necessary perspectives are included. For cross-functional documents, it automatically assembles a review team spanning relevant departments.

Escalation and Availability Handling: We implemented a three-tier backup system:

  1. Primary Reviewer - assigned based on role and expertise
  2. Backup Reviewer - designated alternate from user profile
  3. Role-based Escalation - manager of the role if both unavailable

The workflow monitors task assignment and automatically escalates after 48 hours without action. Escalation triggers email notifications to the backup reviewer and the primary’s manager. Users can delegate their review tasks through the Agile UI, which updates the workflow routing in real-time.

For planned absences, we added an “Out of Office” function where users can designate a substitute reviewer who automatically receives all assignments during the absence period. This is configured through user preferences and integrated with our corporate calendar system.

Audit Trail Completeness: Audit trail was our most critical requirement for FDA compliance. We implemented comprehensive tracking:

Standard Agile Audit Features:

  • All workflow state changes logged with timestamp and user
  • Document field changes tracked with before/after values
  • Electronic signatures captured with meaning and timestamp
  • File attachment history maintained

Custom Audit Enhancements:

  • Notification delivery confirmation (email receipt tracking)
  • Time-in-task metrics (how long each reviewer held the document)
  • Reviewer comments categorized by type (technical/editorial/regulatory)
  • Rejection reasons coded and tracked
  • Parallel review completion order recorded

We created three custom audit reports:

  1. Document Review History - Complete timeline of all review activities
  2. Reviewer Performance - Time-to-review metrics by user and document type
  3. Compliance Summary - Regulatory checklist completion status

These reports pull data from Agile’s audit tables plus our custom tracking attributes. The reports are validated as part of our 21 CFR Part 11 compliance and are used during regulatory inspections.

Validation Approach: For FDA qualification, we followed the GAMP 5 software validation framework:

IQ (Installation Qualification):

  • Verified Agile 9.3.4 installation per Oracle documentation
  • Confirmed PX deployment and configuration
  • Validated lookup table data integrity
  • Checked user role and permission setup

OQ (Operational Qualification):

  • Tested all routing paths with representative documents (45 test cases)
  • Verified reviewer assignment logic for each document type
  • Confirmed escalation and backup reviewer functionality
  • Validated audit trail capture and reporting
  • Tested boundary conditions and error handling

PQ (Performance Qualification):

  • Executed real-world document workflows in production environment
  • Monitored system performance over 30-day period
  • Verified audit trail completeness for all transactions
  • Confirmed integration with email and calendar systems

For the custom PX code, we created a detailed specification document that mapped business requirements to code functions. Each function was unit tested, and we maintained a traceability matrix linking requirements → code → test cases → results.

The validation effort was approximately 200 hours spread across QA, IT, and Regulatory. We treated the PX as a Category 4 (configured system) under GAMP 5, which required moderate validation rigor.

Results and Benefits: After 8 months of operation:

  • 100% review completion rate (previously ~85%)
  • Average approval cycle: 6.2 days (from 12.4 days)
  • Zero missed reviewers or sequence errors
  • Audit trail completeness: 100% verified in last two FDA inspections
  • User satisfaction: 4.2/5 (improved from 2.8/5 with manual routing)
  • Regulatory findings: Zero document control issues (previously 2-3 per audit)

The system now manages 850+ controlled documents and processes approximately 120 document changes per month. The automation freed up about 15 hours per week of document coordinator time, which was redirected to quality improvement initiatives.

Key Success Factors:

  1. Extensive stakeholder engagement during design
  2. Phased rollout starting with one document type
  3. Comprehensive user training on new workflows
  4. Clear documentation of routing rules and escalation procedures
  5. Regular review and optimization of reviewer assignments

The most challenging aspect was getting organizational buy-in for the rigid sequential routing required for compliance. We addressed this through training that emphasized the audit trail benefits and reduced cycle times.

Happy to discuss any specific aspects in more detail!