Any data created as part of a CGMP record must be evaluated by the quality unit as part
of release criteria (see §§ 211.22 and 212.70) and maintained for CGMP purposes (e.g., §
211.180). Electronic data generated to fulfill CGMP requirements should include relevant
metadata. To exclude data from the release criteria decision-making process, there must
be a valid, documented, scientific justification for its exclusion (see the guidance for
industry Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical
Production, and §§ 211.188, 211.192, and 212.71(b)). The requirements for record
retention and review do not differ depending on the data format; paper-based and
electronic data record-keeping systems are subject to the same requirements.