Praxis Validation Center

Based on years of real-world Software Quality Assurance (SQA) experience. Continuously updated with the latest regulatory and industry trends. Validation Center™ is your source for the information and tools you need to validate and maintain computer systems in companies where ICH, EMA, and FDA compliance is required.

SOP Templates

Don't have any policies specific to Computer System Validation or Part 11 Compliance?   Need to compare your policies against an independent framework and leverage ideas?  This section gets your SQA policies and procedures in place fast.

Deliverable Templates

Use the same Software Validation templates that Praxis uses to improve the productivity and consistency of your validation and software quality assurance work.  

Regulations and Guidance

Regulations affecting computer systems in the life sciences are spread over many different organizations and websites.  Here you can access all the software compliance regulations and guidance information you need from the U.S. and Europe in one spot.


Regulatory Actions

What actions is the FDA taking regarding computer systems? Each month we update this section with Warning Letters, 483s, and summaries of enforcement actions taken by the FDA related to computer systems and software. Learn what FDA compliance really means.

References

Industry websites, Praxis training materials and webinars  and other reference materials related to computer system validation and software compliance.

Training

Whether you are new to software validation or an experienced pro, our training workshops will give you the information, insight, techniques, and tools you need to be successful.