Computer Systems Assurance (CSA)
Focus on functionality, patient safety, product quality, and data integrity, increasing the overall quality and reducing overall risk.
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Maintain compliance and save time on validating using Computer Systems Assurance (CSA).
CSA adopts a science and risk-based approach to validating computerized systems. PSC Biotech® CSA consultants are experts in computer software configuration and implementation for life science product manufacturing.
Our Expertise:
- Electronic Document Management Systems
- Laboratory Equipment Software
- Clinical Data Systems
- Data Integrity
- Facility Management Systems
- Adverse Events Systems
- Material Requirement Planning Systems
- Manufacturing Execution Systems
- Management Software Implementation
- Plant Maintenance Asset Management System Implementation
- Quality Management Systems
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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
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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Empowering Compliance: Elevating Computer Systems Assurance with PSC Biotech®
As a global leader specializing in Computer Systems Assurance consulting services, PSC Biotech® works to ensure life sciences companies’ processes are functional and fully compliant with FDA and EMA guidelines. With over 25 years of experience in engineering, auditing, quality, and compliance, PSC Biotech® is equipped and experienced to meet your CSA and CSV needs. Over 1000 clients in more than 50 countries demonstrate the quality of PSC Biotech® professionals.
PSC Biotech® CSA consultants work in accordance with international standards and local regulations. PSC Biotech® CSA consultants systematically follow the International Society of Pharmaceutical Engineers (ISPE) GAMP® 5 model and adhere to current GxP FDA guidance. Upgrading your computerized systems validation (CSV) to CSA techniques will improve your product safety and patient safety by prioritizing the identification of gaps and risks to safety in the validation process. CSA offers many benefits over traditional CSV. To assess the impact and method for upgrading to CSA, contact PSC Biotech® CSA consultants today!
Get Started Today!
Our goals are to provide tailored professional services, act as a seamless extension of life science companies, assist you in producing the highest quality products possible, and ensure processes are functional and in full compliance.
Email us at info@biotech.com/ or use our contact form online below to start building your custom CSA solution. For more information about CSA vs. CSV, request our white paper here.
WHITEPAPER
Download Our CSV vs CSA White Paper
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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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