Helmer Net Industrial Automation

FDA GMP / 21 CFR PART11

Effective. Reproducible. 100% tailor-made for your company

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.

FDA GMP / 21 CFR PART 11 Helmer Net

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Our services

  • • Central documentation for continuous monitoring
  • • Transparency at all times through periodic documentation
  • • No need for manual readout increases productivity
  • • Climatic conditions at a glance
  • • Internal and external quality requirements are met
  • • Everything traceable at all times
  • • Good Manufacturing Practice in medical technology
  • • Reduction of the effort required to achieve and maintain conformity
  • • use of innovations and new techniques
  • • Introduction of effective procedures for change and configuration management
  • • Validation Audit trails Document control Access protection
  • • Electronic records with digital signature
  • • Cleanroom operations
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