For research-based pharmaceutical companies, effective information storage and records management is essential but challenging. Research and product development data; sales, marketing, manufacturing and financial records; and other informational assets are voluminous and ever expanding. The FDA, FTC, SEC, IRS, and other bodies, and their foreign counterparts, all impose strict records retention requirements, as well as penalties for non-compliance. Additionally, companies have a duty to preserve all information relevant to pending or anticipated litigation (whether related to, for example, intellectual property, product liability, or any other claims) or when on notice of a criminal investigation (e.g., investigations concerning antitrust, false claims, or FCPA). The 2006 amendments to the Federal Rules of Civil Procedure now make clear that electronically stored information is subject to discovery. Moreover, these information retention needs must be understood in the context of a world in which technology is rapidly advancing and communication practices are changing. Adding further complexity, privacy laws may place restrictions on the retention and use of records containing personal data.

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An organization’s approach to records and information management must be driven by its specific regulatory and business needs. Regulatory obligations pharmaceutical companies must comply with are particularly complex, and large pharmaceutical companies are continuously involved in litigation and e-discovery. The Pharmaceutical Records and Information Management Organization (PRIMO) works to address these challenges and improve information governance within the pharmaceutical industry by conducting benchmarking, developing compliance tools and good-practice approaches to records and information management, and promoting workable RIM standards.