As electronic spreadsheets and text documents replace paper records, research-driven life sciences firms are turning to electronic content management (ECM) systems to control the flow of digital information. The Food and Drug Administration requires that these systems maintain the digital equivalent of a paper chain. Regulation 21 CRF Part 11 sets strict criteria for electronic signatures and documents. Non-compliance means fines and delays.
MAXLife for Microsoft Dynamics AX makes compliant document management intuitive, easy and accessible to any authorized user — from anywhere. Our technology delivers on the promise of efficiency without sacrificing security and necessary controls. With MAXLife, we can help your Life Sciences business become more competitive and agile. Our technology fosters collaboration among global teams in a secure, compliant environment. Users can easily create, store and find relevant documents in a central repository that meets FDA regulations.
Merit Solutions can help reduce the time and expense of getting drugs to market — improving your business and worldwide health. Benefits of MAXLife include:
- Satisfy 21 CFR Part 11 requirements for audit trails, electronic signatures, restricted access, accurate copies of records, and proper storage. Give remote workers intuitive access to compliant content management — straight from their desktop.
- Facilitate collaboration and role-based productivity.
- Create and store valuable metadata directly within the document — even when it’s checked out of the ECM system.
- Support workgroup collaboration, subscriptions, notifications, message boards and other tools in a secure environment.
- Control R&D costs and accelerate ROI.
- Help speed drugs to market, improving company performance and public health.
