A major provider of supply chain and transport solutions in the Pharmaceutical and Medical Device Industry engaged with SeerPharma to deliver a workshop on Computer System Validation (CSV) to their Global Quality Team in Hong Kong. The workshop focused on CSV as it relates to Good Distribution Practices (GDP), looking to address the Why and How of CSV, and provided an appropriate approach to CSV for GDP Systems.
The workshop addressed an inherent need for the Global Quality Team to be better equipped in handling the compliance requirements for the IT infrastructure used within their operations.
To solve this issue, SeerPharma specifically targeted and provided the following as part of the workshop:
- An understanding of common terms and definitions of Computer Systems Validation
- An understanding of the types of, and elements of System Development Life Cycles (SDLC)
- An overview of Good Automated Manufacturing Practices (GAMP)
- An understanding of what is critical for data integrity in the eyes of GxP regulators
- An understanding of how computer systems are regulated in PIC/S and FDA environments
Contact us if you’d like to learn more about Computer System Validation (CSV) and how best to approach it for your operations within the Pharmaceutical/Medical Device Industry.
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