Tag: Validation principles for software for pharma and medical devices manufacturing

Pharma Software Validation Pharma medical devices manufacturing

Pharma Software validation principles for the validation of software for pharmaceutical and medical device manufacturing. REQUIREMENTSA documented software requirements specification provides a baseline for both validation and verification. The software validation process cannot be completed without an established softwarerequirements specification (Ref: 21 CFR 820.3(z) and (aa) and 820.30(f) and (g)). DEFECT PREVENTION Software quality assurance needs […]

Pharma software validation medical devices pharmaceuticals

Medical devices and pharmaceutical software verification and validation benefits of software validation Software validation is a critical tool used to assure the quality of device software and softwareautomated operations. Software validation can increase the usability and reliability of the device,resulting in decreased failure rates, fewer recalls and corrective actions, less risk to patients and users, […]

Pharma Software validation Regulatory Requirements definition

Regulatory Requirements for Pharma software validation definition. In pharmaceutical and medical device industry many manufacturing process depend on computer software( Also see 21 cfr part 11) in early times there were many cases found, where the medical deices were recalled just because of software malfunction,  later it was found that those faults were caused due to improper implementation […]

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