Confirmation by examining and providing objective evidence that computer system specifications conform to user needs and intended uses, and that all requirements can be consistently fulfilled.
Glossary
Computer Systems Validation
02.27.12
Related Compliance:
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Biologics, Proteins, Vaccines | cGMP Manufacture | Clinical Trial Materials | Collaborations & Alliances | Industry News | Scale-up/Technology Transfer
Merck, Stelis Open First Joint Process Scale-Up Lab in Bengaluru
Combines Stelis' bioprocess development capabilities with Merck's bioprocessing equipment
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Aseptic Processing | Breaking News | Clinical Trial Materials | Collaborations & Alliances | Fill/Finish | Industry News
BioTechnique Launches Phase Two of Manufacturing Partnership
Will manufacture a commercially-available vaccine product in a new, shelf-stable dosage form
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Logistics | Validation
CMO Systems
A CMO system includes four aspects of the product lifecycle: regulatory, technical, compliance, and operations.Philip K. Burns, CRO Consulting
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Bioassay Development | Breaking News | Capsules | Chemistry | Drug Delivery | Drug Development | Industry News | Methods Development | Process Development | Solid Dosage/Semi-solids | Toxicology | Vials
Evoke Achieves Manufacturing Milestone
Completes production of a commercial scale lot of EVK-001 in accordance with CMC
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Validation
