Helmer Net Industrial Automation
VALIDATION OF PROCESSES
The objective here is to provide documented evidence that your process effectively and reproducibly delivers a product (result) that meets the specified quality requirements. With 21 CFR part 11, the FDA formulates requirements for electronic records and signatures that are also directed at medical device manufacturers.
Here, the law of the American health authority FDA 21 CRF Part 11, which has been in force since 1997, on “Electronic Records and Electronic Signatures” enables the transition from paper-based manual processes to computer-supported electronic processes.
We are happy to support you in this process and look forward to hearing from you.