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21 CFR Part 11 is the FDA guideline defines the criteria under which electronic records and electronic signatures considered to be trustworthy, reliable and equivalent to paper records. Part 11, as it is commonly known and was introduced in 1997, applies to FDA-governed industries that choose to store their primary, authoritative records electronically. It stipulates guidelines and rules for storage, copying, access & permissions, audit logs & tracking. It also identifies version control of electronic records and application of electronic signatures to them.
What is QMS (Quality Management System) Software? QMS Management qms system
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What is an EDMS or Electronic Document Management System? An EDMS or Electronic Document Management System is a software lets you create, edit, process, revise, and store documents in text, images, video, and audio files with scanning and printing features. edms
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CAPA Management Software to Identify, Analyze and Prevent risks description: CAPA management software enables you to identify and investigate non-conformance and discrepancies caused in a system for a faster rectification of problem. corrective action software
Best cloud-based highly recommended and rated QMS Software ComplianceQuest QMS Software is 100% cloud-based best QMS software which is highly recommended and rated by top quality management experts. Compare why cheap QMS Software compared to others. best quality management solution
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What is CAPA - Corrective and Preventive Action? CAPA or Corrective and Preventive Action is a way to improve the company’s processes by taking a series of actions that eliminate the recurring events and causes of non-conformities. capa quality management system