For the Record

Life Sciences Series: GxP compliant records management

regulatory compliance and risk - the need for a centralized approach

Regulatory Compliance and Regulations

Regulatory compliance is one of the biggest challenges facing pharmaceutical companies today. The sector has seen a huge increase in regulatory requirements and heightened scrutiny in recent years. In this climate, compliance teams need to keep ahead of complex and ever-changing national and international regulations, as well as a regular schedule of audits. Added to this, siloed departments within company structures can create inefficiencies and challenges in coordination.

Efficient recordkeeping and records management is a central part of demonstrating GxP compliance. The pharmaceuticals industry continues to rely heavily on managing and retaining a large volume of physical records. Typically, most companies are relying on legacy tools from vendors that are no longer updating their software; on custom-developed systems that are difficult to maintain; or on spreadsheets. The hidden costs of this are profound. Staff time is wasted on manually entering information on multiple systems, and it can take a long time to track down records as they change custody. 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.

Centralized View of Records Management

Centralizing information on the physical records and electronic data managed by the Quality, IT and Records Management departments can provide Compliance Committees with greater visibility into the overall volume of records created and retained by the company; the ability to centrally manage who is able to access specific records; and the ability to report on activity and respond to audits more quickly. Automatically capturing chain of custody information can also eliminate the need to manually enter information into multiple systems each time a record is submitted or retrieved. The ability to submit records requests and retrieve records quickly also enables analysts, researchers and product developers to work faster and more efficiently, thus enabling the company to focus more on innovation.