With continued data integrity issues occurring during cGMP inspections, the FDA recently issued a new draft guidance to help the Pharmaceutical industry.
The guidance includes 18 questions and answers on data integrity, alongside well-defined terms on data as they relate to current good manufacturing practice (cGMP) records. It also includes recommendations on when workflows on computer systems need to be validated, and how to ensure electronic master production and control records are monitored, and can only be used by authorized personnel.
“The FDA expects that data be reliable and accurate. cGMP regulations and guidance allow for flexible and risk-based strategies to prevent and detect data integrity issues. Firms should implement meaningful and effective strategies to manage their data integrity risks based upon their process understanding and knowledge management of technologies and business models,” the guidance says.
The Updated Guidance
The FDA defines data integrity as “the completeness, consistency, and accuracy of data. Complete, consistent, and accurate data should be attributable, legible, contemporaneously recorded, original or a true copy, and accurate. A useful acronym has been formulated to help in understanding the principles of data integrity – ALCOA. Broughton Software, a leading supplier of LIMS systems to facilitate regulatory compliance, has produced an ALCOA pocket guide. Please see: http://www.broughtonsoftware.com/alcoa-pocket-guide.
Electronic data generated to fulfil cGMP requirements, which is one of the focal points of many of FDA’s warning letters, should include relevant metadata, according to the 13-page guidance, which defines metadata as “the contextual information required to understand data.”
FDA also makes clear that there must be a good reason why certain data exclusions are made and raises concerns about shared logins to computer systems, which have also been documented in warning letters. “To exclude data from the release criteria decision-making process, there must be a valid, documented, scientific justification for its exclusion,” the guidance notes.
And even if companies are still using paper-based records, the requirements for record retention and review do not differ.
As for audit trails, which the FDA defines as “a secure, computer-generated, time-stamped electronic record that allows for reconstruction of the course of events relating to the creation, modification, or deletion of an electronic record,” the agency says the trails should capture changes to critical data and 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 change history of finished product test results, changes to sample run sequences, changes to sample identification, and changes to critical process parameters.”
Electronic signatures, often used in LIMS systems, can be used instead of handwritten signatures. However, the appropriate controls need to be in place and documented to ensure the ability to identify the specific person who signed the records electronically.
A LIMS system, designed to facilitate regulatory compliance, can aid in meeting the data integrity regulations. Broughton Software is a LIMS developer specialising in regulated markets. If you would like to learn more about how LabHQ LIMS can help please go to: http://www.broughtonsoftware.com/labhq-lims-software
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