Salient CRGT has developed and employs award-winning enterprise IT methods and processes that deliver transformative results to federal agencies, the Department of Defense, and commercial enterprises. Our repeatable, Agile-based approach mitigates risk with proven engineering methods, tools, and frameworks. Our approach drives value and measurable results aligned with our customers’ goals.
Case Study: Enterprise Document Management Platform Support Services
The Food and Drug Administration (FDA)’s mission is to enforce the Federal Food, Drug, and Cosmetic (FD&C) Act and other laws that are designed to protect consumers’ health and safety. Several IT systems assist FDA personnel in tracking and managing cases throughout the regulatory workflow. Electronic Document Management at the FDA began in 1996 when the agency selected Documentum as the platform on which to build their document management applications. The Enterprise Content Management Server (ECMS) is an option available for FDA organizations to store business critical documents.
According to the Presidential mandate, by the end of 2016, federal agencies must manage both permanent and temporary email records in an electronic format. This must occur within a system that supports records management and litigation requirements with the ability to identify, retrieve, and retain the records indefinitely.
The goal of every records management (RM) program is to ensure that records receive proper handling, or disposition, based on the type of record. Permanent records are to be preserved in their original format for transfer to NARA for final preservation. It is important that temporary records be destroyed according to their disposition schedule so that they are not accessible past their intended availability. A robust records management program is important in supporting both FOIA and litigation collection. The suggested constraint in deploying a solution is to offer compliant RM capabilities as a service to the FDA user base as unobtrusively as possible. The goal is to provide an RM service that in no way affects the user communities’ existing work experience unless the service is utilized.
Over the last eight years, FDA’s document management system has seen steady growth of about 21% annually. Estimates show that within the next eight years FDA will surpass the 100 million mark for documents stored.
An effective records management solution requires a centralized records repository approach. Managing records within their native applications is highly ineffective. Selecting centralized systems to collect and manage records reduces the burden of trying to create and keep retention schedules up to date in disparate systems, makes the consistent application of retention schedules easier, and supports the practice of applying “holds” to records whose destruction is being suspended as part of a business activity.
As part of Enterprise Documentum, EMC Documentum Records Manager provides a complete records management solution compliant with the DoD 5015.2 Standard and Title 21 CFR, Part 11. Salient CRGT has successfully implemented the EMC Documentum Records Manager at FDA. The solution at the FDA included the creation of over 1,200 enterprise and business retentions. Customers can manage all records with a single set of policies that meet business needs and help with overall information governance. Documentum RM services enable the FDA to comply with the record keeping and leverage uniform policies regardless of the format of the electronic record (i.e. videos, documents, images).
Features of the solution include:
- Declare records directly from SharePoint document libraries and Microsoft Outlook with an added menu option.
- Manage both physical and electronic records, with strong support for converting physical documents into electronic form.
- Declare records from structured content found in Enterprise Business Systems, custom applications, and databases.
- FDA Records Managers manage retention policies and records efficiently in one place.
- Trusted Content Services and Information Rights Management Services identify the correct record, support digital shredding, provide access auditing, and enforce document disposal even after records are distributed outside of FDA.
The solution provides FDA with records that are:
- Visible by developing and registering standardized metadata.
- Accessible through web services with usable, standardized interfaces.
- Understandable through the availability and use of rich metadata describing the records and their context.
The ERM solution was also designed with the future in mind. Once FDA has transitioned the agency’s business process to full electronic document and record management, the volume of electronic documents will plateau at an estimated 250 – 300 million records — which is well within the capacity of the new ERM system.