GxP SAP Validation: What Auditors Expect

When regulatory auditors review SAP systems in pharmaceutical, medical device, and biotech companies, they're looking for documented evidence that the system consistently performs as intended and meets all applicable regulatory requirements. Understanding what auditors expect is critical to avoiding findings, warning letters, and operational disruptions.

Complete Validation Documentation

Auditors expect a complete validation package that demonstrates your SAP system was validated according to a documented plan. This includes a validation master plan, validation protocols, test scripts with expected results, actual test results, deviation reports, and a validation summary report. Missing or incomplete documentation is one of the most common audit findings.

The validation documentation must be traceable from user requirements through design specifications to test cases and results. Auditors will select specific requirements and trace them forward to verify they were tested and met acceptance criteria. Any gaps in traceability raise red flags about the completeness and rigor of your validation approach.

Risk-Based Validation Approach

Modern regulatory guidance emphasizes risk-based validation. Auditors expect to see documented risk assessments that identify critical system functions, data integrity risks, and patient safety impacts. Your validation effort should be proportional to the risk level, with more rigorous testing and controls for high-risk functions.

The risk assessment should be documented, approved by quality, and used to drive validation scope and depth. Auditors will challenge validation approaches that appear to be one-size-fits-all or that don't adequately address identified risks. They want to see that you understand your system's impact on product quality and patient safety.

Change Control and Ongoing Validation

Initial validation is just the beginning. Auditors expect robust change control processes that maintain the validated state as the system evolves. Every change should be assessed for validation impact, and significant changes should trigger revalidation activities. The change control system must be documented, followed consistently, and integrated with your quality management system.

Auditors will review change records to verify that changes were properly authorized, tested, and documented. They'll look for evidence that validation impact assessments were performed and that appropriate revalidation occurred. Weak change control is a frequent source of audit findings and can undermine your entire validation program.

Data Integrity Controls

Data integrity is a top priority for regulatory agencies. Auditors expect SAP systems to have controls that ensure data is attributable, legible, contemporaneous, original, and accurate (ALCOA principles). This includes audit trails, electronic signatures, access controls, and backup/recovery procedures.

Your validation documentation should demonstrate that data integrity controls were tested and are functioning as intended. Auditors will review audit trail reports, test data modification scenarios, and verify that unauthorized changes are prevented. Any gaps in data integrity controls are considered serious findings.

Vendor Documentation and Qualification

While vendor documentation can support your validation, auditors expect you to have performed vendor qualification and to supplement vendor materials with company-specific validation evidence. You cannot simply rely on vendor test results or certifications. Your validation must demonstrate that the system works correctly in your specific configuration and use case.

Auditors will ask about your vendor qualification process, vendor audit results, and how you leverage vendor documentation. They expect to see that you've critically evaluated vendor materials and filled any gaps with your own testing and documentation.