In the extremely competitive and highly regulated pharmaceutical industry, records management is a critical requirement.  Whether it’s tracking intellectual property files, or providing a central repository to manage electronic records and drug research notebooks, Accutrac provides a powerful solution for the demanding pharma sector.

21 CFR Part 11

In 1991, members of the pharmaceutical industry met with the U.S.  Food and Drug Administration (FDA) to see how they could accommodate paperless records under the current good manufacturing process (CGMP) regulations. The FDA created a Task Force on Electronic Identification/Signatures to develop a uniform approach by which the agency could accept electronic signatures and records in all program areas. As a result, in the Final Ruling, Part 11 (21 CFR part 11) provided that electronic records can be used in lieu of any paper records, and that electronic signatures shall be equivalent to handwritten signatures.  The Accutrac XE™ records management platform provides an enterprise class records management system that can manage both physical and electronic records throughout their lifecycle to support these requirements.

Multi-Media

The pharma industry must track a vast array of item types. Records may include research reports, lab notebooks, emails, trial results in many formats, and other complex statistical information. With a robust multi-level hierarchy in addition to unlimited item types, Accutrac® provides flexible solutions to meet demanding pharmaceutical Records Management requirements.

Security is Critical

Security is a major requirement for pharmaceutical organizations to meet stringent guidelines.  Rest assured knowing that Accutrac® XE™ is certified by the U.S. Department of Defense (DOD 5015.2 certification) for optimal security and retention.  With robust control and access features, our clients can leverage existing network authentication protocols while providing options for deployment to end users via Internet server options. Security can be applied to users, groups as well as items while supporting Legal Holds management to support compliance and mitigate risk.

Corporate Legal Records

Accutrac® has built a great reputation over the years with law firms.  As such, companies looking to get a better handle on their internal Legal records have called upon Accutrac to do the same for their organizations.  Often times, corporate Compliance in the pharma environment have critical needs to track intellectual property records (Patents, copyrights, trademarks, critical dates) as well as highly regulated product development records. Initiatives tend to start with the General Counsel’s office where the need to more effectively manage Legal records of the organization becomes critical to meet corporate compliance objectives, improve records discovery in the face of audits and litigation, and to mitigate risk.  Accutrac XE™ offers a powerful scaleable system to support everything from legal departmental records tracking, to global complex records management deployments.

Open Systems

Accutrac XE™ provides a robust platform that facilitates integration with corporate and legacy systems, like electronic signature applications in the pharmaceutical industry that supports a central database repository while providing options to link to federated databases and other systems.  This facilitates deployments in complex IT environments while improving productivity of records management staff. And to aid deployment to remote users and offices, Accutrac® provides a Web Server product to facilitate access to the application while maintaining security parameters.