Qualification and validation
according to the latest standards
We create your qualification documents (FDS, HDS, SDS, FMEA, RA) for the validation of machines for the pharmaceutical industry, taking into account your User Requirement Specification (URS) as well as FDA regulations, EC GMP guidelines and GAMP4.
- SL innovativ GmbH qualification principles
- DIN ISO 9001:2008
- FDA 21 CFR Part 210/211
- FDA 21 CFR Part 11
- EC GMP guidelines annex 15
- EC GMP guidelines annex 11
- GAMP4
- DIN EN IEC 62079 (VDE 0039) "Preparation of Instructions - Structuring, Content and Presentation"
- VDI 4500 "User information" with sheets 1, 2 and 3 (in preparation)
- Internal documentation guidelines