Quality Assurance

With Quality Engineers

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Quality Assurance is a PSC Biotech® core principle.

We focus on compliance, quality systems, process, and product design, quality control, and more. All PSC Biotech® consultants are trained in QA, and quality engineers can assist you with specialized QA requests.

Our Quality Assurance Expertise:

  • Change Control
  • Assessment of Change Request (ACR)
  • Risk Management
  • Deviations and Non-Conformance
  • Investigation Reports
  • CAPA – root cause investigation and implementation of corrective & preventative actions
  • Quality Agreements
  • Customer Complaints Documentation
  • Stability Reports
  • Regulatory Inspections
  • Regulatory Documentation
  • Staff Training
  • Review and Approval of Validation Documents
  • Internal audits
  • External audits
  • Audits planned
  • Audits executed
  • Reports issued
  • Vendor audit responses
  • Audit close-outs
  • Audit Reports including different levels (Critical, Major, Minor, or Observation)

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PSC Biotech® Industry Expertise

Cosmetics, Cannabis
Pharmaceuticals, Personalized Medicine
Medical Devices, Biotechnology
Tissue Products, Cell and Gene Therapy
Food & Beverages, Homeopathic, Nutraceuticals

PSC Biotech® Technical Writers work to your project needs. See our project success pages for examples. To start the process of gaining a PSC Biotech® Technical Writer to design, validate, implement, optimize, review, write or otherwise assist in technical writing, contact us today!

LIFE SCIENCE EXPERTISE ON DEMAND

What makes PSC Biotech® the partner of choice for leading life science companies? It’s our full-service approach to ensuring your facilities, equipment and processes meet regulations set by leading regulatory bodies. Access the full spectrum of software and service solutions your company needs to thrive. Contact a PSC expert today.


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Related Project

Commissioning of the new manufacturing science and technology (MSAT) lab.
Commissioning Project Summary Qualification Validation

Commissioning of the new manufacturing science and technology (MSAT) lab.

PSC Biotech experts were assigned to commission the architectural finish and mechanical completion of the Manufacturing Science and Technology (MSAT) Laboratory. The commissioning took place parallel with the final construction process. This helped our CQV experts to directly start and complete the project.

Commissioning Of The New Apheresis Inspection And Processing Spaces
Commissioning Project Summary Qualification Validation

Commissioning Of The New Apheresis Inspection And Processing Spaces

The commissioning team successfully completed the modifications to the air handling system according to the client’s specifications and design. They checked the changes to the supply and return ductwork, as well as the new and existing variable air volume boxes.

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