Pharmaceutical Innovation & GxP Compliance: The Role of Records Management

pharmaceutical records management

Faster Innovation & Growth of Information in Pharmaceuticals

Pressure to bring new products to market faster has never been greater. At the same time, records and information management is growing more challenging by the day. Isn’t it time you upgraded your records management system?

For pharmaceutical companies, efficient recordkeeping and records management are a central part of demonstrating GxP compliance. Even as the use of electronic records grows, physical records continue to play a critical role in every stage of the product lifecycle. From R&D and clinical trials to regulatory approval, manufacturing, quality assurance, and sales and marketing — effective records management matters.

Many pharmaceutical companies rely on a combination of tools to track their records — using custom-developed software that is difficult to maintain; on legacy tools from vendors that are no longer updating their software; and/or on spreadsheets.

The hidden costs of this are profound. Too much staff time is spent manually entering information on multiple systems. It can also take a long time to track down records as they change custody. Furthermore, delays in tracking down and retrieving records can mean unnecessary delays in responding to regulatory audits, which can in turn trigger warnings and significant fines.

Streamlining Pharmaceutical Records Management

Looking up and finding the physical records you need should be as easy as finding your electronic documents. And with more staff spending more time working remotely, it saves time to be able to search for the physical records you need without having to send an email or submit queries in person each time. 

Modern pharmaceutical records management systems (RMS)  should enable the Records, Quality and Information Management teams to easily:

  • Centralize information on physical records and electronic information
  • Restrict access to information to authorized users only
  • Automatically track chain of custody
  • Capture a complete record of all activity
  • Manage and apply records retention schedules

Compliance Committees benefit from visibility into the overall health of your records management and information management program — not to mention the ability to respond to regulatory audits quickly. The ability to submit records requests and retrieve records quickly also enables analysts, researchers and product developers to work faster and more efficiently and focus on delivering innovation.