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Data integrity, questions and answers

Data integrity is challenging and very hard to be managed. Sometimes is about the company culture, in other occasions is about a clear understanding of the requirements

Find below a few interesting Questions and Answers clarified by FDA

What are metadata?

Metadata is the contextual information required to understand data. A data value is by itself meaningless without additional information about the data. Metadata is often described as data about data. Metadata is structured information that describes, explains, or otherwise makes it easier to retrieve, use, or manage data.

When is it permissible to exclude CGMP data from decision making?

Any data created as part of a CGMP record must be evaluated by the quality unit as part of release criteria and maintained for CGMP purposes (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.

How often should audit trails be reviewed?

FDA recommends that audit trails that capture changes to critical data be reviewed with each record and before final approval of the record. Audit trails subject to regular review

should include, but are not limited to, the following: the change history of finished product test results, changes to sample run sequences, changes to sample identification, and changes to critical process parameters.

Can electronic signatures be used instead of handwritten signatures for master production and control records?

Yes, electronic signatures with the appropriate controls can be used instead of handwritten signatures or initials in any CGMP required record. While in some instance it is specified a “full signature, handwritten,” as explained in the Federal Register on September 29, 1978 (43 FR 45069), part of the intent of the full signature requirement is to be able to clearly identify the individual responsible for signing the record. An electronic signature with the appropriate controls to securely link the signature with the associated record fulfills this requirement. This comports with part 11, which establishes criteria for when electronic signatures are considered the legally binding equivalent of handwritten signatures. Firms using electronic signatures should document the controls used to ensure that they are able to identify the specific person who signed the records electronically.

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