Computer Systems Assurance (CSA)

Focus on functionality, patient safety, product quality, and data integrity, increasing the overall quality and reducing overall risk.

Computer Systems Assurance (CSA) takes a science and risk-based approach to validating computerized systems. PSC Biotech® consultants are experts in CSA configuration and implementation. Maintain compliance and save time on validating using CSA.

As a global leader specializing in Computer Systems 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 30 countries demonstrate the quality of PSC Biotech® professionals.

For more information on CSA vs CSV, request our white paper here

Computer Systems Assurance Specialties:​

Top 5 CSA Facts:

1. Risk is based on the impact on patient safety, product quality, and data integrity measured against requirement complexity.

2.  Computer Systems Assurance calls for documentation that adds value to the validation.

3. CSA reduces paperwork with unscripted and ad-hoc testing.

4. CSA results in fewer issues encountered in production.

5. The FDA and ISPE support Computer Systems Assurance not only for medical device manufacturing but also for pharmaceutical and biotech companies.

Computer System Assurance CSA PSC Biotech CSV

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 using our contact form online below to start building your custom CSA solution. For more information about CSA vs CSV, request our white paper here

How Can We Help You?

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.”

Download Our CSV vs CSA White Paper

Related Projects

CRM & Vault Modules Projects

Cross-regional CRM and Vault Module CSV & OQ Test Scripts, IOQ Protocols, and Traceability Matrices Projects.

Remediation Transition Validation & Compliance

Validation and compliance project for the transition of computerized systems from the previous system.

Commissioning and Qualification Projects

Equipment Qualification, Computerized Systems Validation, IT, QA, & More.