VALIDATION SERVICES

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What are IQ OQ PQ and why are they critical?

We create all documents necessary for the computer system validation for you or together with you. From the validation plan to the validation report. We have been providing this service to our customers for twenty years - our documents have been used in countless audits. Computer system validation aka CSV enhances the reliability of system, resulting in fewer errors and less risk to process and data integrity.

It is intended to reduce long-term system and project costs by minimizing the cost of maintenance and rework. To achieve such long-term goals, it is necessary to implement processes.

CSV is a critical tool to assure quality of computer system performance. IQ OQ PQ or Installation Qualification, Operational Qualification and Performance Qualification are 3 independent and documented procedures used together to check and test that a mechanical, piping or software system is:

  • installed correctly
  • meets its design requirements and specifications
  • operates the way in which it was designed under load

Becoming Validated

During implementations, biomedion helps customers establish a focused validation methodology that facilitates the adoption of software upgrades while maintaining quality and addressing risk. As a standard part of practice, biomedion supports customers with planning, managing, testing, and preparing for validation. biomedion regularly hosts customer audits upon request.

Checklist

Validation Deliverables

  • Master Validation Plan (MVP)
  • Business Requirement Document
  • Installation Qualification (IQ) Protocol
  • Operational Qualification (OQ) Protocol
  • IQ Scripts and Results
  • OQ Scripts and Results
  • Trace Matrix (through OQ)
  • Validation Summary Report (VSR)

  • System Release Memo
  • Configuration Specification
  • Configuration User Requirement Specification (URS)
  • User Acceptance Testing (UAT) Protocol
  • UAT Scripts
  • UAT Summary Report
  • Trace Matrix (through PQ)

regulatory

Scripts

Test scripts defined in DevOps to cover platform and solution configuration

validation

Testing

Automated testing execution for all product updates (regression)

qualification

IQ/OQ

Automatic IQ/OQ execution output deliverables provided

performance

Performance Qualification

PQ test scripts provided for customer execution

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CONTACT US

For further information please contact us, we look forward to hearing from you.

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MORE SERVICES

We offer a variety of different services to help our customers with many aspects of the drug development process and document organization.

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Extraction of results from images of any kind. We use our years of experience in image computing to help you get the best results as quickly as possible.

 

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