For decades, paper-based quality management has been the mainstay in medical manufacturing. As reporting requirements tighten, however, Regulatory agencies want companies to replace aging methodologies with solutions that assure much tighter data and process integrity. Mandatory updates may be close at hand.

Are you ready for what’s coming next?

Many forward-looking small and mid-sized companies understand this development and are preparing now for a new way to manage changes. An integral component of their corporate compliance strategy is Reaction.

Reaction is an intuitive, easily deployable application that provides full quality support for the entire life of Changes, Packaging Changes, CAPAs, Deviations, OOS, and Claims — from request through approval, implementation, verification, and closure. The application allows the presiding Quality System Director and Regulatory Office to easily manage Changes, Claims, OOS, and Deviations lists required for Annual Reports.

Reaction creates a central, secure repository for all workflow and related documents, reducing the time required to complete flow-related operations. Reaction’s built-in archive and search engine also accelerate the retrieval of information related to completed operations.

Reaction is in compliance with FDA 21 CFR part 11, EU EudraLex Vol 4 annex 11 Computerised Systems. PIC/S annex 11

For a more detailed explanation of Reaction’s features and functionality, click here to download the product brochure. Or click here to schedule a live demo session.