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.
- 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
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.
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!
PSC Biotech® Industry Expertise
Pharmaceuticals, Personalized Medicine
Medical Devices, Biotechnology
Tissue Products, Cell and Gene Therapy
Food & Beverages, Homeopathic, Nutraceuticals
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.
Download Our CSV vs CSA White Paper
What Our Clients are Saying
“During the past year, our company has been working with PSC™ on various activities within the development and implementation of a new medical device product. PSC™ offers high quality services, and we can say that we have always been satisfied by their work.”
“The skillsets that PSC™ provides in regulatory support helped us overcome a large obstacle in particular. The regulatory support that we had from PSC™ was very independent and if we had an issue, PSC™ consultants were willing to work cross-functionally to meet our needs. No micromanaging required. Great communication. Minimal supervision. I don’t think we would have been as successful without them. The expertise and the connections we’ve created with PSC™ are beyond our expectations. I’ve never had that relationship with a company like I’ve had with PSC™. Just phenomenal! It made my life easier.”
“This is to certify that PSC Biotech® (PSC™) has done a good job for our company in the range of auditing and consultancy. Their work was remarkably distinguished as auditors. As consultants, their work was successfully handled and enabled based on the level of expertise of their team in the U.S. and abroad.”
CRM & Vault Modules Projects
Remediation Transition Validation & Compliance
Validation and compliance project for the transition of computerized systems from the previous system.