Case study

QA & Compliance for Pharmaceutical Fortune 500


Million $ Facility


Pieces Qualified

Our feature

Laboratory Buildout & SOPs

Our feature

Equipment Validation

Quality control laboratory buildout – commissioning and qualification of a newly built gene therapy lab from construction to release.

lab documentation

Quality Control Laboratory Buildout

  • Commissioning and qualification of a newly built gene therapy laboratory from construction to release
  • Required a full time, dedicated project manager, fully staffed validation and computer system validation resources.
  • ANSA was tasked with providing full project schedule for timelines of deliverables and resource loading.
  • $120 million gene therapy manufacturing facility
  • Resources worked with system owners to develop URS, Config Spec, IQ, OQ, PQ, Trace matrix, Summary Reports and full validation project plan.
  • Worked with client team to produce processes that were not developed at the time of qualification, so we provided consulting on quality of validation processes, risk assessment processes, csv processes, IT security processes, and system admin processes. 
  • Qualified over 70 pieces of equipment and instrumentation, including complex systems, enterprise systems and simple systems.
  • Worked on implementing work station back up solutions for the site
a line up of microscopes in a lab


laboratory documentation on digital device

Provided Technical Writing Support for the LIMS Implementation Project

  • Admin Standard Operating Procedures (SOP)
  • General Use (SOP)
  • EM (SOP)
  • Wis
  • Training Material (PPT)
  • On the Job Training (OJT) Forms

Validation Documents

  • URS
  • System Risk Assessment
  • Configuration Specifications
  • Trace Matrix
  • Data Integrity Assessment
  • Validation Summary Reports
  • Validation Plans
  • Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) documents
  • Installation/Operational Qualification (IOQ) Addendums
  • Discrepancy Report Forms (DRF)
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