validation

Validation Process

The Challenge

  • Developing a Global Product Authentication System introduces (1) totally new processes; (2) new equipment; (3) processes and equipment which have been altered to suit changing priorities; and (4) processes where the end-product could potentially be an unreliable indicator of product quality (e-coding/serialization and traceability/e-pedigree).
  • Because of the above, validating a Global Product Authentication System becomes an integral part of quality assurance and involves the systematic study of all related systems, facilities and processes. It is aimed at determining whether they perform their intended functions adequately and consistently as specified.
  • Corporate Health Initiatives Consulting (CorpHI) draws on its regulatory portfolio and extensive documentation expertise in meeting state, federal and international requirements to address the client's specific needs. Our expert associates will work closely with the client's team to design a compliance strategy that will enhance client employees' knowledge and client company's bottom line.
    • CorpHI associates regularly develop both site Master Plans and project-specific Validation Master Plans.
    • CorpHI plans guide the entire project team toward the identified goals related to a facility that can be validated in compliance with all applicable regulations.

The Opportunity

  • CorpHI is proficient in writing and performing Installation Qualification (IQ) Protocols to ensure that the equipment received is in good condition, as designed, and properly installed in the manufacturing environment. CorpHI works together with its clients to develop and execute Operational Qualification (OQ) Protocols that ensure process equipment and ancillary systems are capable of operating within established limits and tolerances. CorpHI's validation associates have extensive experience with Performance Qualifications (PQ) of laboratory, manufacturing and packaging facility systems.

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