Aoife Plunkett attended a session discussing the FDA’s Case for Quality, the challenges of CSV, and the requirement for critical thinking across all business departments and processes.

On 29th July 2020, Veratrak’s Quality Assurance Manager, Aoife Plunkett, attended a session on GAMP®5, FDA CSA, and the Future of Computer Systems Validation, hosted by ISPE.

During this talk, industry experts discussed the FCD CDRH Case for Quality, and how GAMP® supports this focus on quality over compliance, by encouraging the use of innovative technologies, and the application of effective good practices.

ISPE’s Specific Interest Groups (SIGs) were discussed. These SIGs are responsible for researching and publishing reports on new technologies, and include GAMP® Blockchain, GAMP® Cloud Computing and GAMP® Data Integrity, which tie in with our product at Veratrak and our process for developing new features.

The final section of the discussion demonstrated how critical thinking, knowledge management, quality culture and maturity, and data governance are all essential for effective Computerised System Validation.

Key takeaways from the webinar:

  • Critical thinking and risk based approaches should be prioritised, rather than documentation and compliance.
  • Increased investment in automation, and utilising cutting edge computerised tools, allows companies to proactively manage risks to quality, resulting in a more productive environment and overall lower quality related cost.
  • Organisations need to establish a strong quality culture, throughout all business departments and processes, spearheaded by senior management.
  • Quality Risk Management is at the heart of Computerised Systems Validation approach.
  • Veratrak is a quality focused company, committed to continuous improvement, and has incorporated learnings from this discussion into our company strategy. Get in touch to find out how we can improve collaboration, security, and visibility outside the walls of your business.


    Who are we?

    Veratrak's documentation management and collaboration platform allows Pharmaceutical Supply Chain companies to better collaborate, increasing security and efficiency. Our practical use of blockchain technology provides a rock solid audit trail of documentation handovers for our customers.