Validation Testing

All versions of ProCal software are internally validated before release. Whether you choose the GAMP4 or GAMP5 approach, our IQ/OQ protocols combined with ProCal Subject Matter Experts guarantee the most economical method to meet regulatory compliance.

Whether you need to comply with FDA, GMP/GAMP, ISO 17025, ISO 9001, ISO 14001, ISO 13485, ISO/TSI 16949, AS9100, NIST, Mil Spec , ANSI or others, ProCalV5 delivers reliable, robust performance. Prime Technologies’ proven development and testing practices are routinely audited and approved by leaders in the Life Sciences and other regulated industries. Our experienced team of product specialists and technical writers are available to support your project with the following Validation and Testing Support Services:

  • Validation strategy document
  • Risk assessment
  • cGMP compliant Test plan
  • Installation validation protocol development, IQ
  • Operation & Performance Qualification Protocol, OQ, PQ
  • Supervision and execution of validation and UAT
  • Validation summary documents

Request Examples of Validation Protocols

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