21 CRF Part 11 is a section of the Code of Federal Regulation (CFR) which was established by the United States FDA details the criteria for electronic records and signatures. While the 21 CFR relates to Pharmaceuticals and Medical Devices, Part 11 of the regulation is specifically concerned with electronic records and electronic signatures. The regulation permits and authenticates the wide use of electronic technology, compatible with FDA’s requirements to protect public health records. The regulation considers electronic records and signatures to be equivalent to paper records and handwritten signatures. The CFR Part 11 outlines requirement that ensures the authenticity of electronic data and provides guidance to US companies on how they can submit documentation in an electronic form and electronic signatures in alignment with FDA regulation. The CFR Part 11 Compliance encourages organizations to conduct business digitally and ensures the authenticity of electronic data and signatures.
Conduct an initial study of the business to understand the business processes, the environment and accordingly consolidate the scope.
Our team spends significant time with your team to determine IT systems and controls that need to be secured and audited.
Assess your organization's current compliance status against the CFR Part 11 standard to identify areas that need to be addressed.
Identify your sensitive data and assets, and classify them to create an asset inventory.
Our team conducts a comprehensive Risk Assessment to identify weak areas that could be exploited and lead to an incident of the breach.
Our team helps you build strategies and appropriate Risk Treatment measures to help bridge gaps and strengthen security systems. We also assist you in developing and implementing a data breach management response that can blend with your existing Incident Response Plan.
Our team assesses your product/application against the standard requirements to ensure CFR11 compliance.
Our team of experts will conduct User Training programs for all personnel covered in scope on their specific CFR 11 Compliance responsibilities. Training materials for future use shall be provided.
Develop effective documentation for your organization as per the CFR Part 11 requirements.
We will help you build and rollout effective policies and procedures for your organization, pertaining to CFR Party 11 Compliance.
After a reasonable gestation period, a separate team of experts conducts a Pre-assessment of your setup and ensures all measures are implemented.
Our team will provide you complete support and assistance in helping you achieve certification from external auditors.
If required we can extend our continual support by offering you Managed Compliance Services to help your organization stay certified.
The purpose of establishing CFR Part 11 is to ensure the authenticity of electronic data and signatures and make them equivalent to paper records and handwritten signatures.
The 21 CFR Part 11 applies to clinical research organizations, pharmaceutical, and medical device companies, who are conducting FDA-regulated research. Any organizations conducting clinical research in the U.S, or submitting their drugs and devices to the FDA for approval, need to comply with CFR Part 11. Every tech or medical device used in clinical research must be compatible with the CFR Part11.
The 21 CFR Part 11 applies to any records that are required by the FDA and are being maintained electronically instead of in a physical format. This includes any electronic document records required by the FDA and mentioned in the Predicate Rule.
The FDA considers electronic signatures equivalent to handwritten signatures but requires the electronic signatures to include the printed name of the signer, date and time of the signature executed, unique user ID, digital adopted signature, and meaning of the signature with labeled signing reason.