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.