Aspects of this philosophy spilled over to some analytical instrument qualification, mirroring the interpretation of FDA process validation — testing a parameter once at OQ stage and three times at PQ ...

This is followed by process mapping, PK performance qualification protocol development, and system validation. After completing qualification phases, system management, represented by ASP, will be ...

The author explores differences between two qualification documents, the draft guidance from FDA "Process Validation: General Principles and Practice" and the ASTM E2500-7 standard "Guide for ...

FDA states that validation of computer systems is a documented, formalized procedure used for testing computer systems and software needed by Federal Regulations (21 CFR 11.10.a).

CSI IP Reliability Testing: In addition to ISO 26262 compliance, reliability testing is crucial to ensuring the long-term performance and durability of CSI IP products. Reliability testing helps ...

Dublin, Aug. 15, 2023 (GLOBE NEWSWIRE) -- The "Process Validation Guidance Requirements course (FDA and EU Annex 15: Qualifications and Validation) Course" training has been added to ...