21cfr part 11 is used for validating records Adultfree chat
The QMS system serves as a system-of-record for the systems validation project.
All documents including SOPs, specifications and test plans are stored in its repository.
Such computer systems must be validated to ensure accuracy, reliability, consistent intended performance, and the ability to discern invalid or altered records.
This guidance is now being held up to the rest of the FDA-regulated world as an example of best practices in computer system validation.
To successfully manage compliance, each regulated system must be proven to operate in accordance with its intended use and design, and all documentation supporting that evidence must culminate in FDA-acceptable documentation.
The FDA’s General Principles of Software Validation - “Final Guidance for Industry and FDA Staff”, published jointly by CDRH and CBER was originally written with the medical device industry as its intended audience. This guidance describes how certain provisions of the medical device Quality System regulation apply to software and FDA’s current approach to evaluating a software validation system.
Hence, this requirement applies to any software used to automate device design, testing, component acceptance, manufacturing, labeling, packaging, distribution, complaint handling, or to automate any other aspect of the quality system.
In addition, computer systems used to create, modify, and maintain electronic records and to manage electronic signatures are also subject to the validation requirements.
Systems that maintain certain employee training records may even be subject to validation.
After the root cause has been identified, Corrective Action (CAPA) items are created.
When corrective actions are approved, appropriate changes are implemented in the environment through a change-control process and then the CAPA is closed out.