The high costs of compliant content management
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.
Microsoft has partnered with industry-leading solution providers to deliver secure, compliant and collaborative document management systems -- right out of the box.
Existing ECM systems provide document control -- but at the expense of efficiency and ease of use. Because outside collaborators have trouble accessing these systems, the pace of research suffers. The systems are not intuitive, so even internal users become frustrated.
Add to that the inability of existing systems to store metadata -- filing tags such as authors and dates and other important contextual information -- within documents. Critical information becomes unavailable whenever a document is checked out of the system. Besides crippling the document search process, these systems make managing the "corporate truth" impossible.
These systems are expensive, yet offer little benefit over paper records. They impede collaboration -- and waste precious time as critical patent protections run down.
Compliant collaboration
Life sciences firms need ECM systems that satisfy the requirements of 21 CFR Part 11. Systems must provide audit trails, electronic signatures, strict access control, accurate copies, and proper storage of all document versions. They must be validated to produce reliable, accurate information. But the needs of business exceed FDA regulations. A system must be intelligent and easy to use, so team members around the globe can upload, store and search documents that preserve content with its valuable associated metadata
Microsoft and partner solutions
Microsoft has partnered with industry-leading solution providers to deliver secure, compliant and collaborative document compliance systems -- right out of the box.
Our combined solutions are intuitive. They leverage a common interface that integrates familiar office applications with line-of-business systems.
Our compliant technologies extend to the Web, allowing remote users to collaborate in real time from anywhere in the world. This easy-to-understand system lets users access and store documents within the familiar office business applications they rely on to create and modify content.
Even better, our system automatically captures and uploads metadata stored within the document itself and makes it available for searching within the ECM system. This valuable information is always available -- even when a document is checked out of the system.
Our ECM systems are delivered in environments that can be validated for regulatory authorities. Our solutions use the power of the Microsoft platform to provide an easy to use ECM system that allows customers to keep the total cost of ownership down while driving adoption up. This is in stark contrast to the traditional ECM vendors.
Faster time to market
Microsoft's technology platform 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.
Our partner solutions seamlessly integrate compliance procedures and metadata storage. Metadata is automatically updated and stored every time a document is checked into the system. No time is wasted on manually entering new metadata upon check-in.
And because the metadata is complete, document searches are more productive.
Microsoft can help your 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.
Microsoft can help reduce the time and expense of getting drugs to market -- improving your business and worldwide health.
Efficiencies that scale
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.
