Whether you’re running a biologics manufacturing plant, managing clinical trial data, or operating a quality management system, your computerized systems play a critical role in ensuring product quality and patient safety. But systems age, users change, processes evolve—and what worked flawlessly two years ago might be a compliance risk today.

That’s where periodic reviews come in.

What Is a Periodic Review?

A periodic review is a structured, documented assessment that confirms a GxP computer system continues to operate in a validated state, remains compliant with regulatory requirements (like FDA 21 CFR Part 11 or EU Annex 11), and is still fit for its intended use.

Think of it like a health check for your critical systems. You’re not necessarily retesting everything, but you’re verifying that the “system ecosystem”—software, procedures, training, data, change history—is in good working order.

Key Considerations in a Periodic Review

A well-executed periodic review should answer several key questions:

Is the Validation Still Current?

Start by reviewing the original validation and any revalidations or major changes since. Has the system changed? Were those changes validated properly? Are documents stored in a compliant document management system?

Example: A biotech lab’s LIMS (Laboratory Information Management System) was validated in 2021, but since then, there have been two major software updates and a module addition. Each change must be assessed for proper validation.

Who Has Access and Are They Trained?

Access control is a major component of GxP compliance. Review user access logs, deactivation of former users, and training records. Ensure only trained, authorized personnel can use the system.

Example: A new QA analyst was granted system access but had not completed their training module. This is a red flag during a regulatory inspection.

Change Management and Deviations

All changes should follow your formal change control process, with documented impact assessments and validation activities. Deviations and incidents should be reviewed for trends or unresolved issues.

Tip: Two or more similar deviations in the review period might signal an adverse trend—and require root cause analysis.

Data Integrity and Backup

Your system should have tested backup and restore procedures, audit trails, and disaster recovery plans. Regulators expect proof these processes are not just documented but tested and effective.

Support and Vendor Dependencies

Confirm that vendor support is still available and that service level agreements (SLAs) are current. If the vendor has discontinued support, you need a contingency plan.

Inspection and Audit History

Were there any audit or inspection findings related to this system? Have those findings been addressed and closed? This section often overlaps with change and deviation management but deserves specific attention.

Business Continuity

In biotech, even brief system outages can impact patient safety or data integrity. Periodic reviews should verify business continuity plans are up to date and tested.

Common Pitfalls to Avoid

  • “No Changes = No Review” Mentality: Even if nothing changed, systems still age. You may have obsolete documentation, expired training, or unsupported software.
  • Incomplete Documentation: A thorough review isn’t just checking boxes. Make sure observations, conclusions, and follow-up actions are well documented.
  • Missed Trends: Don’t just react to issues—analyze for patterns. Two minor issues with data backups might indicate a systemic flaw.

Best Practices

  • Use a Standardized Review Template: Ensure consistency across systems and sites.
  • Automate Notifications: Use tools like ValGenesis or CMMS to trigger reminders and track completion.
  • Cross-Functional Participation: Include business owners, QA, IT, and system users to get a full picture.
  • Don’t Wait for the Deadline: Plan reviews annually or based on system criticality. If a major change or incident occurs, consider conducting an ad-hoc review.

In biotech, periodic reviews are about more than ticking off compliance boxes. They’re about maintaining confidence in the tools that ensure your products are safe and effective. In an industry where lives are on the line, taking a few days each year to scrutinize your systems is time well spent. Regulators don’t just want to know your systems were validated. They want to see that they remain validated.