CSV Support

Ensuring Compliance & Quality with CSV/CSA in Life Sciences

The life sciences industry is evolving rapidly, bringing groundbreaking advancements in medicine and patient care. To ensure patient safety, product quality, and data integrity, Computerized System Validation (CSV) and Computer Software Assurance (CSA) play a critical role in the production of safe medicines and medical products.

As digitalization continues to transform the life sciences sector, including pharmaceuticals, biotech, high-end food production, clinical trials, and medical devices (MD) regulatory compliance becomes more complex. Governments enforce strict regulations to maintain the highest standards, requiring companies to implement CSV/CSA frameworks.

Whether you're adopting traditional validation or shifting to a modern, risk-based CSA approach, we deliver:

  • Regulatory compliance 

  • Efficient, audit-ready documentation

  • Risk-based strategies to reduce cost and complexity

  • Expert support for cloud, SaaS, and agile environments

Pharmavalley can provide support related to validation of computerized systems throughout the entire system life cycle:

  • Initiation/ concept/selection phase

    execution/supervision of Initial qualification and validation  (project phase)

    changes/ requalification/validation during production phase

    System retirement phase