FDA 21 CFR Part 11
FDA 21 CFR part 11 is a set of guidelines established by the United States Food and Drug Administration (FDA) that defines the criteria under which electronic records and electronic signatures are considered to be trustworthy, reliable and equivalent to paper records. Specifically, these guidelines require drug makers, medical device manufacturers, biotech companies, biologics developers, and other FDA-regulated industries to implement various controls for software and systems involved in processing electronic data. These controls include audits and audit trails, system validations, electronic signatures and other documentation that is required to be maintained by various FDA regulations.
Impact
These guidelines affect medical device manufacturers, drug producers and other biotech organizations, and refers to all records in electronic form that are created, modified, maintained, archived, retrieved, or transmitted under any records requirements set forth in FDA regulations. Part 11 also applies to electronic records submitted to the agency under requirements of the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act, even if these records are not specifically identified in agency regulations.
Challenge
Many companies are managing quality risk assessment documents in disparate systems or even paper-based systems, making it difficult to ensure proper document control. Documents must be secure and follow a set system for document control, or they will be at risk of being unacceptable. In-house document control is an important aspect of meeting Part 11 guidelines – if faced with an audit, a proper audit trail, record retention and record copying must be proven. This is difficult to obtain without a quality system in place that can help manage risk assessment data in one place. Without an organized system for electronic documentation, organizations may be in danger of non-compliance.
The Dyadem Solution
Dyadem provides comprehensive Quality Risk Management (QRM) solutions that enable global Medical Device, Pharmaceuticals and other related companies to reduce risk management effort by 50%-80%. With Stature, the centralization of all risk assessments and related documents in a single database, allows searching and reporting across all risk analyses for post-market surveillance. Working as a document management system, Stature can provide action tracking, provide recommendations for future risks, and generate reports and dashboards to improve visibility across all divisions and departments. In addition to improved quality and reduction in compliance risks, Dyadem solutions can help ensure you successfully retain all records from risk assessments should you be faced with an audit of your electronic records and signatures, providing full traceability for FDA compliance.
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