Validation

Evolution Scientific provides a full scope of validation services for Manufacturing and Process Equipment, Equipment Processes, Facilities and Utility Equipment, Analytical and Laboratory Equipment, and Computer and Software systems.

Our team of validation engineers is familiar with current FDA requirements for validation and has the expertise to ensure your facility and processes are compliant with all applicable regulations.

Computer Validation

The computer validation team at Evolution Scientific can assist in all of your computer validation needs. We are thoroughly familiar with the GAMP guidelines for software validation and have experience in validating or qualifying networks, operating system software, instrument software, and equipment software. Our computer validation package can include the following:

  • Validation Master Plan
  • User Requirement Specifications (URS)
  • Functional Requirement Specifications (FRS)
  • Installation Qualification (IQ)
  • Operation Qualification (OQ)
  • Performance Qualification (PQ)
  • Gap Analysis
  • Traceability Matrix
  • Risk Assessment
  • Validation Summary Reports

Equipment Validation

Evolution Scientific is experienced in the qualification or validation of a wide variety of manufacturing and analytical equipment. Our team of engineers can guide you through the process of developing a design qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) that meets your needs and complies with regulations.

Evolution Scientific can validate all type of manufacturing and analytical equipment including the following:

  • Environmental Chambers
  • Refrigerators/Freezers
  • Incubators
  • Autoclaves
  • Centrifuges
  • Washers
  • Tablet Presses
  • Depyrogenation Ovens
  • HPLC
  • Gas Chromatography Systems
  • Atomic Absorption
  • Ion Chromatography Systems
  • Cryogenic Freezers
  • Bioreactors
  • pH meters
  • Polarimeters
  • Titrators
  • ... and much more!
Process Validation

Evolution Scientific can assist in your process validation needs. Our team of specialists will develop a process and validation protocol ensuring consistency and reliability with specifications that are attainable under typical and challenged conditions. We will identify critical process parameters and develop in-process and final product specifications that guarantee a reliable, risk free process.

Evolution Scientific offers our customer’s a turnkey approach to validating computers systems, equipment, and processes. The goal of Evolution Scientific is to provide the customer with a service that will lead to effective business risk management, improved product quality, and a “value added resource” to their organization.