Validate Software Used in GMP Data Acquisition Systems

Always Validate Software Used for Data Acquisition in GMP

Remember: Any software system used for capturing GMP data must be validated to ensure accuracy, reliability, and regulatory compliance.

Why This Matters in GMP

In modern pharmaceutical manufacturing, electronic systems are commonly used to acquire, store, and report critical GMP data. Unvalidated software may contain errors, produce inaccurate data, or lack necessary audit trails. This undermines product quality and regulatory compliance. Software validation ensures the system performs as intended, under all operating conditions, and protects against data corruption. It is a cornerstone of data integrity and compliance with ALCOA+ principles. If the system fails or is manipulated, batch release decisions and product safety may be compromised. Hence, validation must cover the entire system lifecycle—from design to decommissioning.

Also Read: Conduct Periodic Pest Control Audits in GMP Storage Areas

Regulatory and Compliance Implications

FDA 21 CFR Part 11 and EU GMP Annex 11 require computerized systems used in GMP processes to be validated. WHO GMP and Schedule M also mandate validation of software for data collection and product release decisions. During audits, inspectors review validation protocols, risk assessments, qualification records, and change control logs. Lack of software validation can result in data integrity observations, 483s, or product holds. Regulators expect documented evidence that systems are tested, secure, and compliant with intended use requirements.

Implementation Best Practices

Develop a software validation plan covering user requirements, functional specs, and risk assessment.
Execute IQ/OQ/PQ protocols and retain all documentation in validation files.
Control access to validated software and maintain complete audit trails.
Revalidate systems upon upgrades, configuration changes, or extended usage.
Train QA, IT, and end-users on software validation and data handling protocols.

Also Read: Avoid Operating Equipment Without Completing Logbook Entries

Regulatory References

FDA 21 CFR Part 11 – Electronic Records and Electronic Signatures
EU GMP Annex 11 – Computerized Systems
WHO GMP – Validation of Computerized Systems
Schedule M – Validation and Electronic Data Systems