Is infoRouter Document Management Software 21 CFR Part 11 compliant?
Active Innovations, Inc, provider of the infoRouter Integrated Document Management System, is committed
to partnering with our customers in meeting our mutual goal of the design and production of products of the
highest quality and reliability. Many of our customers in FDA-regulated industries, such as the design and
manufacturing of pharmaceutical and medical device products, rely on infoRouter as an integral software tool
within their Research and Development and Quality Assurance processes.
The infoRouter Enterprise Server aids organizations in their compliance efforts by meeting all of the
requirements of 21 CFR Part 11. Active Innovations, Inc., through its solution providers and in-house
Technical Services group, provides software validation services as part of the deployment of
infoRouter Enterprise Server.
infoRouter Document Management System provides an integrated document management system for the storage, approval and archiving of data, results, reports, SOPs and any other type of document. The infoRouter Document Management System satisfies all of the 21 CFR Part 11 requirements.
Pharmaceutical organizations can rely on InfoRouter Enterprise Server to perform the following functions in a manner that is compliant with the requirements in 21 CFR Part 11:
- Store and access documents for review
- Deliver information about clinical trials
- Track regulatory applications
- Manage records
- Communicate and assign tasks
- Monitor research and development
- Control workflows and processes
- Store and manage changes to SOPs
To read more about infoRouter 21 CFR Part 11 compliance click here.
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