Release Documents¶
All release documents are provided prior to a project initialisation. These documents describe RMS, certify validation and refer to the qualification documents.
| Validation Plan (VP): RMS-VP-Vxxx-EN.pdf |
Rotronic procedure and planning of a software validation, including releases. |
|---|---|
| Validation & Compliance Declaration: RMS-CD-Vxxx-EN.pdf |
Rotronic certification of validation: Rotronic AG certificate. |
| eCompliance White Paper (WP): RMS-WP-Vxxx-EN.pdf |
FDA 21 CFR Part 11 & EU Annex 11: USA & EU instructions. How RMS fulfils the statutory requirements. |
| Functional Specification (FS): RMS-FS-Vxxx-EN.pdf |
Description of all RMS software functions. Individual parts of this FS are used in the system validation. This document can be used for creation or review of the User Requirements Specification (URS). |
| Change Log (CL): RMS-CL-Vxxx-EN.pdf |
Description of all modifications made to the RMS software. |
| Validation Schedule (VS): RMS-VS-Vxxx-EN.pdf |
Description of the schedule required to carry out a system validation, including roles and responsibilities. |
| eCFR — Code of Federal Regulations, U.S. Government Publishing Office: Code of Federal Regulations (Link) |
FDA 21 CFR Part 11: USA instructions. |
| EudraLex The Rules Governing Medicinal Products in the European Union: annex11_01-2011_en.pdf |
EU Annex 11: European instructions. |
| Comparison of FDA’s Part 11 and the EU’s Annex 11: Comparison of FDA Part 11 and EU Annex 11.pdf |
Comparison of FDA 21 CFR Part 11 and the EU Annex 11. |