About Valkit.ai

Empowering Validation Through Innovative Digital Solutions

Our founding partners have been creating innovative Life Science software solutions for the last 20 years, founding and exiting one of the premier global Life Science validation services organizations.

Through that experience, we realized that legacy Digital Validation tools were built for a bygone era. We knew we could do better—and we have. Valkit.ai maximizes quality and productivity in validation teams while dramatically reducing CQV, CSV, and CSA timelines.

Guided by a board of senior leaders with deep domain expertise in Life Science technology and Artificial Intelligence, Valkit.ai is revolutionizing digital validation workflows for life science companies—accelerating compliance and operational efficiency across the industry.

Our Mission: To streamline and digitize validation processes, enabling life science organizations to meet global regulatory requirements swiftly and accurately.

What We Do:
  • Commissioning and Qualification (C&Q)
  • Computer System Validation (CSV)
  • Computer Software Assurance (CSA)
  • Instrument Validation
  • Lab Validation
  • Cleaning Validation
Our solution ensures compliance with major regulatory bodies worldwide, including:
  • US Food and Drug Administration (FDA)
  • Chinese National Medical Products Administration (NMPA)
  • UK Medicines and Healthcare products Regulatory Agency (MHRA)
  • European Medicines Agency (EMA)
  • World Health Organization (WHO)
  • Australian Therapeutic Goods Administration (TGA)
  • Saudi Food and Drug Authority (SFDA)
Why Choose Valkit.ai:
  • Efficiency: Accelerate validation processes and reduce time-to-market.
  • Accuracy: Minimize human error through digitization.
  • Compliance: Stay current with evolving global regulations.
  • Flexibility: Adaptable to various validation needs across life sciences.
  • Cost-effectiveness: Streamline resources and reduce validation expenses.

Our Vision: We aim to set the global standard for digital validation in life sciences, empowering companies to bring life-changing innovations to market faster and more efficiently.

Experience the future of validation with Valkit.ai—where compliance meets innovation.