Computer System Validation
This guide aims to suggest the tools and strategies necessary and appropriate for use in the validation of computerized systems for (human and veterinary) Pharmaceutical Industries, Pharmaceutical Chemicals (APIs and excipients), and Medical Devices, used in activities related to compliance with Good Practices (GxP), activities include:
- Manufacturing / Production (GMP)
- Clinics (GCP)
- Laboratory (GLP)
- Good Distribution Practices (GDP)
- Storage (GWP)
- Data Integrity.
- Documentation (GDP)
It provides a suitable approach to compliance with all types of computer systems, according to national and international regulations; based on the guidelines established in the GAMP® 5 Guide ISPE, providing an understanding of the logics of work, definition of scope, and selection of the validation strategy that best suits the system to validate.
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