CQV
Commissioning, Qualification, and Validation
End-to-End Solutions
- Project Planning
- Validation Master Plans (VMP)
- Integrated Commissioning and Qualification (ICQ)
- User Requirements Specifications (URS)
- Standard Operating Procedures (SOPs)
- Risk Assessments
- Protocols
- FAT
- SAT
- Validation Protocol Format
- Design Qualification (DQ)
- Installation Qualification (IQ)
- Operational Qualification (OQ)
- Performance Qualification (PQ)
- Good Automated Manufacturing Practice (GAMP)
- Current Good Manufacturing Practice (cGMP) Review
- Summary Reports
- Traceability Matrixes
- Calibration Matrix
- Continued Process Verification (CPV)
- Pre-Operational Verifications
- Commissioning and Startup
- Technical Audits and Due Diligence
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PSC Biotech® provides end-to-end solutions for commissioning, qualification, and validation.
Our team of professionals supports life science companies in all aspects of the CQV lifecycle. We facilitate a timely and cost-effective solution tailored to your company’s budget and requirements.
Our Expertise
PSC Biotech® is one of the largest providers of Commissioning, Qualification, and Validation services in the life science industry. The PSC Biotech® CQV team consists of seasoned experts in validating facilities, utilities, equipment, computer systems, processes, cleaning, test methods, and more. Our team of professionals can support your company in the entire CQV lifecycle. We facilitate a timely and cost-effective solution curated for your company. By outsourcing your CQV needs, you can focus on other aspects of your company while also accelerating your business. While working with PSC Biotech®, your organization will continuously gain insightful knowledge to grow your company.
Facilities Equipment
Utilities Equipment
Processes
Cleaning Validation
Test Method Validation
Greenfield CQV Projects
New Production Site Commisioning
Decommissioning
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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® Commissioning, Validation, and Qualification consultants work to your project needs. To start the process of gaining a PSC Biotech® CQV consultant to design, validate, implement, optimize, review, investigate, audit, or otherwise assist in commissioning, qualification, and validation, contact us today! See our project success pages for examples of our CQV projects with life science companies.
Examples of routine projects for PSC Biotech® CQV engineers include equipment validation and qualification of chambers, autoclaves, tunnels, lyophilizers, packaging, shipping, related process equipment, and associated document generation and revision.
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.
We accelerate with our trusted partners
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Streamlined Validation & Commissioning: PSC Biotech® Experts at Your Service
PSC Biotech® has the experts you need for services ranging from creating a validation protocol format, a validation master plan (VMP), training, technical audits, and due diligence to software validation, paperless validation, and more.
PSC Biotech has commissioning engineers to assist you in projects large or small. PSC Biotech® engineers readily facilitate greenfield facility startup services and facility remediation services with integrated commissioning and qualification (ICQ), Good automated manufacturing practice (GAMP), Continued process verification (CPV), Pre-Operational Verifications, Validation and Verification (V&V), Processed Analytical Technology (PAT) capabilities.
We provide end-to-end solutions with expertise in project planning, CQV master planning, requirement specifications, risk assessments, commissioning, decommissioning, FATs, SATs, installation qualifications, operational qualifications, performance qualifications, summary reports, traceability matrixes, calibration, temperature and humidity mapping services, and more. Our consultants have access to our global Subject Matter Experts and training materials 24/7 and guarantee quality when delivering your projects.
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WHITEPAPER
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OUR projects
Related Project
Computer System Validation for a Pharmaceutical Client
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.
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
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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