Due to international market requirements, retroactive validation is required for a module in a laboratory information system for entering microbiological samples and results. To enable this, user documentation, brief instructions and a glossary are created for the functions of this module.
Supplement
The Adobe Framemaker 7.2 author system is applied for the user documentation. A help file and user manual (in the form of a PDF document) are created from a single source file. Webworks Publisher for Framemaker is used to create the help file.
Subject description
Within the framework of ISO14971, which requires controlled risk management for medical applications (medical devices, IVD), documentation for user guidance is a required standard that must be available at the market launch for a piece of software.