Validation and Testing

End-to-end Quality Assurance and Regulatory Compliance


Process StreamTM provides our clients with the tools necessary to develop and maintain compliant IT systems and applications, and having excellent validation processes is a vital part of that; not only does validation mitigate your risks and manage your liability, providing a valuable layer of protection for both you and consumers, it reduces unnecessary testing and costs by providing a consistent, coherent, and integral system for defining and applying standards. An indispensable process in numerous highly-regulated industries, particularly pharmaceutical, biotechnology, and medical devices, our validation services are tailored to your business, your industry, and your project for maximum compliance protection.

Process StreamTM 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.

Our team of qualified and GxP experienced validation professionals work with you to develop a unique and specially-tailored validation package which meets the specific needs and risk of every project, including comprehensive and tested documentation and procedures running from validation plan to validation summary, constructed according to a formal set of standards for templates. Our resources are highly experienced in providing validation services that make use of electronic testing methods including HPQC and HPALM, as well as validating any integration or web service components of a TrackWise® implementation.

Process Stream’sTM validation processes are rigorous and systematic, and applies to the range of testing environments, including:

  • Test scripts
  • Regression testing
  • Integration testing

Process StreamTM can create, modify, or execute all critical protocols for end-to-end quality assurance:

  • Installation Qualification (IQ)
  • Operation Qualification (OQ)
  • Performance Qualification (PQ)

Process StreamTM is a leader in validation services for regulated industries, and our experience and expertise can help manage your risks and protect your business. We make sure we’re always up-to-date with regulatory changes, which means you’re always able to keep your validation processes current and optimized.


 
Shionogi
Johnson And Johnson
Abbott
Baxter
Applied Materials
Therakos
Tandem Diabetes Care
convaTec
Alexion
Green Mountain Coffee
CareFusion
Mylan
P And G
Allergan
Sanofi
Merck
Purdue
Novartis
Johnson And Johnson