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.
Praxis Validation Center
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.
Recent updates
| Title | Updated |
|---|---|
| Validation and Part 11 Compliance Apply to Servers Too | 05/20/2013 - 17:55 |
| The New 21 CFR Part 11 | 05/20/2013 - 15:31 |
| How Much Validation is Enough? It Depends. | 05/20/2013 - 15:30 |
| Quality Risk Management the ICH Way | 05/20/2013 - 15:28 |
| The Validation Center™ Blog | 05/20/2013 - 15:26 |