Records Management

informationA mid-size biotechnology company needed to address specific information governance and technology issues that impeded its ability to comply with FDA and legal litigation requirements. Areas of concern included the inability to quickly provided content and documents during an e-discovery process and the significant work effort necessary to file timely FDA regulatory documents of almost any nature or type. In addition, repeated breakdowns in content processes resulted in contempt-of-court judgments and late and inaccurate FDA filings for NDA’s, ANDA’s and other critical FDA materials. These problems were exacerbated by the rapid growth of the company and its planned growth of 1,000% within 3 years.

The problems were traced to a number of historical factors, including:

  • Multiple content and document technologies were added over the years creating a patchwork of competing, inconsistent and disconnected information silos;
  • The organization had little understanding of its critical content and documents, their locations and ownership, and their operational status and recency;
  • Few, if any, content processes (automated or otherwise) were in use save for the most basic QA processes;
  • Records management efforts had been stalled without any cohesive approach developed or management buy-in achieved; and
  • Content and documents supporting IP, FDA and scientific and clinical processes were scattered across thousands of folders, dozens of servers, hundreds of repositories and over ten different content technologies.

Content systems needed to be either aggregated or sunsetted. Mission critical documents and content needed to be identified and transitioned. Comprehensive information governance policies and procedures needed to be created, approved and implemented. Personnel needed to be assigned to specific roles and duties and measured accordingly.

Working closely with client personnel, InFuture LLC quickly helped the CIO make informed decisions about an updated ECM technology platform that met the company’s budget and growth requirements while also addressing the appropriate legal and compliance needs of the company. InFuture LLC also worked directly with General Consul to develop a records management approach and schedule that met e-Discovery and records management requirements while meeting the capabilities of the chosen technologies.

InFuture LLC redesigned the Quality Assurance document approach and workflow processes supported by the new system, greatly reducing mistakes and rework and improving compliance with 21 CFR Part 11 guidelines. Finally, information governance approaches and procedures were created and implemented using InFuture LLC’s experience and methodology and successfully rolled out to the organization’s personnel.