What Is 21 CFR Part 11?
21 CFR Part 11 states that electronic records and electronic signatures are to be are equated with paper records and handwritten signatures. Regulated companies having any documents or records in electronic format must comply with the regulation. 21 CFR Part 11 simplifies records can be management and signing processes by allowing the use of the digital technology for these quality are have very main or important functions. FDA-regulated companies will naturally benefit from greater speed and better efficiency, which can be achieved with the right Quality Management System (QMS).
FDA 21 CFR Part 11 Compliance Requirements
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Master Control Document
Complies with Subparts A, B and C, Section 11.3 by providing time-stamped audit trail, reporting and electronic signature capabilities. Security features include double passwords for document approval. It also has password expiration, encryption and authentication. Account lockout prevents unauthorized users from gaining system access.
Master Control Validation Excellence Tool (VXT)
Subpart B complies with Clause 11.10 by providing a risk-based approach to testing and software adoption. This drastically cuts down on testing time and reduces the overall verification burden, allowing companies to conduct complete verifications in just a few days or hours.
master Control change control
Complies with Sub-Part B, Section 11.10 by automating every step of change control processes, allowing you to achieve faster turnaround times. The optimization report shows the real-time status of change control functions and the entire quality system.
master Control Training
Complies with Subpart B, Section 11.10 by automating the management of all training processes. Easily route, follow-up and enhance training. Provide online exams, allow group sign off and automate the sequencing of training tasks.