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FDA 21 CRF 11 & Annex 11
Title 21 CFR Part 11 is the portion of the Code of Federal Regulations that provides standards determined by the Food and Drug Administration (FDA) on electronic records and electronic signatures. With electronic records widely used in the Life Sciences industry, most companies will find FDA 21 CFR Part 11 applicable.
Regulated companies with documents or records in electronic format must comply with FDA 21 CFR part 11. Part 11 pertains to pharmaceutical companies, manufacturers of medical devices, biotechnology companies, CROs, biologics developers, and other companies regulated by the FDA.
Part 11 helps companies safely maintain data securely so that it is not lost or corrupted, ensures companies are implementing systems and software correctly, makes sure there are data-trace changes and prevents falsified records.
Modules include:
- Impact of 21 CFR Part 11 on the organization's computer systems, including Quality Management Systems
- Identification of the organization's computer systems and operating environment
- Hosting and interpretation of user interviews
- Review and consideration of organizational procedures
- Analysis of procedural documentation, validation, and audit data
- Regulatory significance of the computer systems
- Annex 11 for European Union compliance
FDA 21 CFR Part 11 Compliance Solutions
Compliance around these particular requirements are designed to ensure that electronic records and electronic signatures used meet FDA standards for reliability, validity, and security. They include document management systems, solutions to ensure that electronic signatures are as secure and valid as paper records, audit trails and automated record keeping, and of course, data security measures like encryption.
Part 11 is about streamlining the process of electronic record keeping for improved automation, efficiency, and security. It defines the criteria and standards needed for storage, access, and to transmit electronic records.
Why Choose Us
Continuum GRC offers all of the resources, guidance, and solutions required to be in compliance with FDA 21 CFR Part 11. We have the deep experience to do a thorough assessment of your current practices and bring them up to speed. Because this certification is primarily electronic records related, we’ll do a deep-dive into your processes and infrastructure and recommend improvements to make them more efficient and secure.
Our IT risk management solutions are used and trusted by the world’s leading companies. We understand the complexities involved in governance structures and requirements. Continuum GRC oversees each step of the process to simplify implementation.
FAQ
What is FDA 21 CFR Part 11 compliance?
This is designed to ensure that electronic records and electronic signatures used by industries regulated by the FDA (like medical device companies) are trustworthy, and equal to handwritten records. Electronic data must be verified, maintained, and stored in ways that ensure authenticity, confidentiality, and integrity.
What is the difference between 21 CFR Part 11 and Annex 11?
These guidelines are both focused on electronic records and signatures and how they’re handled. 21 CFR Part 11 governs electronic records and signatures around FDA activities like clinical trials and manufacturing.
Annex 11 are similar guidelines established by EU’s Good Manufacturing Practice (GMP), focused on broader computerized systems used in GMP-related activities.
Does my system need to be 21 CFR Part 11 compliant?
If your system is used to create, maintain, modify, or transmit records linked to FDA regulation, then, yes - your system needs to be compliant with these requirements. Also, if your system handles any kind of data used in FDA activities or regulated by the FDA, it needs to meet these compliance standards.
What is an FDA 21 CFR Part 11 compliant system?
It’s a computerized system following the regulations laid out by 21 Part 11 in the Code of Federal Regulations, specifically related to electronic records and signatures. The system should ensure the accuracy, consistency, and reliability of these respective electronic components as if they were the equivalent of paper records.
Can FDA 21 CFR Part 11 compliance be achieved without paper records?
Part 11 is designed to allow electronic records and signatures to be used in place of paper records. The requirements are meant to ensure that these electronic components are as trustworthy and reliable as paper documents. Part 11-compliant technology helps the organization reduce reliance on paper records.
What is the role of risk management in FDA 21 CFRPart 11 compliance?
Risk management processes include assessing potential risks to electronic data integrity, discrepancies between Part 11 requirements, and remediation plans around any vulnerabilities. It streamlines the process of pinpointing compliance issues and fixing them. Continuum GRC knows exactly what to look for and how to make remediation simpler.
What are you waiting for?
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Contact us using the form below or calling us at 1-888-896-6207 for immediate assistance.