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cfr 21 part 11 compliant software

cfr 21 part 11 compliant software

21 CFR Part 11 software systems meet the complex regulations that provides criteria for acceptance by the FDA of electronic records and signatures as equivalent to paper records and handwritten signatures.The use of software for electronic records for submission to FDA is voluntary. 21 CFR Part 11 is about electronic records and record keeping, while the second part governs electronic signatures.

The software provides sophisticated data encryption and storage, administrative and multi-level user security profiles, and tools for manipulating and retrieving data. We Medival Technology provide this service of cfr 21 part 11 compliant software to our clients in pune, navi mumbai, mumbai, thane, aurangabad, goa, maharashtra, karnataka over india and in European nations Hungary, Belarus, Austria, Serbia, Switzerland, Germany, Holy See, Andorra, Bulgaria, United Kingdom, Montenegro, Luxembourg, Italy, Denmark, Finland, Slovakia, Norway, Ireland, Spain, Malta, Croatia, Moldova, Monaco, Liechtenstein, Poland, Iceland, San Marino, Albania, Lithuania, North Macedonia, Slovenia, Romania, Latvia, Netherlands, Russia, Estonia, Belgium, Czech Republic, Greece, Portugal, Sweden.

cfr 21 part 11 compliant software

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