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European Biopharmaceutical Review

A Guiding Light




In 2017, data integrity issues were cited in 65% of all FDA warning letters. The main reason was incomplete data. In the pharmaceutical and biotechnology industries, this can be prevented by ensuring the trustworthiness and reliability of electronic records, a process that is also known as compliance with data integrity. The highest risks, when not working in a compliant manner, lie in import bans, product recalls, or even the closing of production plants.

The FDA defines the criteria under which electronic records and electronic signatures are considered trustworthy, reliable, and equivalent to paper records in Title 21 of the Code of Federal Regulations (21 CFR) Part 11.

By becoming FDA 21 CFR Part 11 compliant, organisations benefit from:
• Reduced costs by removing manual and paper processes while improving workflow processes
• Reduced costs of managing and documenting their entire record lifecycle, from routing and approval workflow, version control, and comparison to audit trails and reports
• Improved traceability – e-records are simpler for gathering, filtering, and presenting information for internal use or FDA audits
• Stronger controls over users’ ability to design, amend, and approve forms
• Better management of global data, including product data, symbols, graphics, and languages
• Compliance with data integrity requirements

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Angela Bazigos is the CEO of Touchstone Technologies Silicon Valley, a firm dedicated to providing expert compliance consulting and support services to pharma, biotech, medical devices, CMOs, and CROs. Angela is a co-author and prototype contributor of 21 CFR Part 11 guidance with the FDA. She continues to collaborate with the FDA on new guidance documents.

Shweta Nair is the Senior Product Manager, Biotechnology portfolio, at Advanced Instruments, a manufacturer of scientific analysers that serves the biotech and pharma industries. The company recently launched a portfolio of osmometers that include data integrity features in support of 21 CFR Part 11 and EU Annex 11 compliance.
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Angela Bazigos
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Shweta Nair
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