You’re a Quality, IT, or Operational manager working for a Pharmaceutical / Medical Device company, responsible for the computer systems used in-house. Working in the Pharmaceutical / Medical Device industry, means that regulators such as the FDA and TGA will scrutinise the use and validation of these business critical systems.
To perform effective Computer System Validation (CSV) in your industry, one must:
- Perform a risk assessment on your Computer Systems and focus on the critical elements that affect your patients and your business as a whole.
- Understand the current computer system industry standards for security, data transfer, and audit trails
- Have a thorough understanding of best industry practice and guidelines e.g. Good Automated Manufacturing Practices (GAMP)
- Address the types of, and elements of, System Development Life Cycles (SDLC) as applicable to your computer systems
- Appreciate the compliance, risk and regulatory consequences of using Computer Systems
Companies are becoming ever reliant on computer systems, and with the emergence of newer technology platforms and a push from regulators to query your “Data Integrity” it is imperative to have a holistic understanding of the approach towards Computer Systems Validation.
Contact us for expert guidance and hands-on assistance with your CSV activities, based-on our vast experience assisting companies similar to yours within the Asia-Pacific region.
Or you may be interested in our Computer System Validation training.