Process Stream is an industry leader in validation services for regulated fields, providing organizations like yours with the tools to effectively test your system implementations while mitigating your risk and managing your liability. This indispensable layer of ensuring system validity with your process and the regulatory environment helps ensure compliance at every level.

Our team of qualified, GxP-experienced quality experts and validation professionals work closely with you to develop a validation solution tailor-fit to your business, your industry, and your project, ensuring maximum compliance protection from end to end.

Process Stream’s validation solutions meet the specific needs (and risks) of every project, and include:

  • Comprehensive documentation and procedures for the full suite of Validation Deliverables
  • Test script authoring and execution
  • Integration testing
  • Regulatory Impact (Determine GxP vs. Non-GxP)
  • GxP Risk Assessment (Determine Validation Effort)
  • Validation Plan
  • Requirements Specification
  • Installation Qualification (IQ)
  • IQ Summary
  • Design Specification
  • Author Test Plan
  • Author Test Scripts
  • Requirements Traceability Matrix
  • Execute Test Scripts
  • Author Test Summary Report
  • Validation Summary
  • Training Plan
  • Release For Use
  • Deployment Plan

Process Stream consultants provide rigorous and systematic validation procedures to guarantee maximum control and compliance every time, and because we keep our finger on the global pulse of the quality systems and control space, we’re always up to date with the latest regulatory changes. That means that we can support keeping  your validation processes current – and compliant.

Process Stream validation services are designed to align with the 21 Code of Federal Regulations (21 CFR) and FDA guidelines for pharmaceutical, biotech, and medical device manufacturers.