21 CFR Part 11
MSB Docs recognizes the importance of complying with regulatory requirements specific to industries such as pharmaceuticals, biotechnology, and medical device manufacturing. In accordance with 21 CFR Part 11, we offer a comprehensive solution that meets the compliance needs of organizations operating in these highly regulated sectors.
21 CFR Part 11, issued by the U.S. Food and Drug Administration (FDA), establishes criteria for the use of electronic records and electronic signatures in lieu of traditional paper-based systems. Our document management platform is designed to adhere to the stringent requirements of this regulation, enabling organizations to transition to a more efficient and compliant digital environment.
With MSB Docs, you can generate, store, and sign electronic records with confidence, knowing that our solution complies with the specific controls and security measures outlined in 21 CFR Part 11. We have implemented robust access controls, audit trails, and data integrity mechanisms to ensure the authenticity, integrity, and reliability of electronic records and signatures.
Our platform offers features such as user authentication, electronic signatures, and version control, which are essential for maintaining compliance with 21 CFR Part 11. These features provide a secure and traceable system for document management, ensuring that records are accurate, protected against unauthorized access, and tamper-proof.
In addition to the technical safeguards, MSB Docs provides the necessary documentation and validation support to assist organizations in their compliance efforts. We offer comprehensive validation packages and documentation that align with the requirements of 21 CFR Part 11, easing the burden of compliance for our customers.
By choosing MSB Docs as your document management solution, you can confidently navigate the regulatory landscape governed by 21 CFR Part 11. Our platform empowers organizations to leverage the benefits of electronic records and signatures while ensuring compliance with the FDA’s stringent requirements. Focus on advancing your scientific endeavors and product development, knowing that your electronic records and signatures are secure, reliable, and compliant with 21 CFR Part 11.