The European Medicines Agency has released a new Annex 11-Computerized Systems to its GMP Guide Chapter 4 on Documentation to account for the increased use of and complexity of computerized systems in ...
System documentation should include a system description, history, validation information, and references, according to Siegfried Schmitt, Vice President, Technical at Parexel. Q. Some 10 years ago, ...
Title 21 CFR Part 58 provides guidance on Good Laboratory Practice (GLP) for executing non-clinical laboratory studies that support applications for research permits for Food and Drug Administration ...
US FDA Electronic Records 21 CFR Part 11, Computerized Systems Health Canada Good Manufacturing Practices (GMP), Guideline GUI-0001 European Union EudraLex Good Manufacturing Practices Vol 4 PIC/s ...
Analytical equipment should be qualified and computer systems should be validated to demonstrate suitability for the intended use. Electronic records must comply with FDA Part 11 and EU/PICS GMP Annex ...
Computerized systems are those which comprise the components shown in Figure 1.1, namely, a computer system and a controlled function which is operating within its specified working environment. The ...
“This renewal of our validation is a significant achievement for GrowerIQ and our clients,” said Andrew Wilson, CEO of ...
Increasing adoption of CSV in regulated industries is a key factor propelling growth of the global computer system validation market. The use of computer systems can automate, accelerate and improve ...
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