Electronic Document and Record Compliance for the Life Sciences
Organizations dedicated to the life sciences have the conflicting needs of ever shorter development cycles, while maintaining strict compliance to US and International regulations. The need for speed and efficiency is driven by competitive market demands; the failure to meet compliance standards can result in costly delays and even penalties.
In order to maintain compliance, organizations are put under intense pressure to process vast amounts of paper and electronic data. This information is related to each minute phase of the development, testing, and submission phases of product development, and extend fully to the end-of-life of the product.
In addition, if the flow of information is not efficient, the organization can be exposed to huge litigation risks. This risk is often engendered by a lack of proper management of the massive volumes of information.
To avoid or minimize these risks, life sciences organizations should adopt new information management strategies. The clear and proven path is the electronic record and document content management system. These systems enable the organization to manage their information throughout project inception, creation, review, processing, transmission, storage, as well as the archiving and dissemination phases. This approach offers a systematic and procedurally sound approach to the unique needs of product development and life cycle management in the life sciences.
N2 Workflow and Document Content Management from Solusoft is a proven, state-of-the-art solution for information management in the life sciences.

N2 from Solusoft
The objective of the paper is to show how N2 can meet 21CFR Part 11 Compliance. The 21 CFR Part 11 is defined as records in electronic form that are created, modified, maintained, archived, retrieved, or transmitted under any records requirements set forth in FDA regulations. The technical and procedural controls for 21 CFR Part 11 Compliance enforce controls on information access, change management, tracking, notification, training, work flow and administrative controls on authentication, authorization and integrity of records.

Benefits of Compliance

1. Authentication: Authorized users allowed access to electronic information

2. Authorization: Only authorized individuals can access certain or complete parts of the information universe

3. Change Control: Ability to track changes to electronic and printed document records (i.e., changes were made by: who, what, when, and why?)

4. Retrieval Tracking: Monitor and track the retrieval of the information

5. Workflow: Proactively manage the information life cycle from inception, creation, review, process, transmission, storage, archiving, and dissemination

6. Record Authenticity: Digital signature provided to maintain document authenticity and integrity

7. Long Term Storage: Provide archiving, retention and purge capability

8. Protected Transmission: Information transmitted from authors to CRO, to technicians, to reviewers, and to consultants is protected via encryption

Business Benefits

1. Elimination and minimization of regulatory risks, fines and process delays

2. Increase in credibility due to regulatory compliance

3. Minimization or elimination of patent violations

4. Organization and management of structured and unstructured information

5. Enforcement of the best practices to protect the intellectual property of the organization