Why You Need a GxP Archivist in Your Organisation

The moment the inspector steps through the door (e.g. let’s say from the MHRA), the pulse of a Life Sciences company quickens. It’s not just another routine visit, it’s a high-stakes assessment that can make or break reputation, operations, and even the future of a product. The pressure is substantial, and the consequences can be profound. In the world of Pharmaceutical and Biotech, an inspection from the MHRA isn’t just a tick box exercise; it’s an event that demands precision and a great deal of preparation.

Despite scenarios like the one mentioned above, many often overlook the need for a professional GxP archivist which in reality can provide so much value to Pharmaceutical and Biotech organisations.

What is a GxP Archivist?

A GxP Archivist is responsible for managing and organising data in compliance with Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), Good Clinical Practice (GCP) and other regulatory standards. This professional ensures that all documentation, records, and information related to research, development, and manufacturing processes are accurately maintained and easily accessible. With meticulous attention to detail and a deep understanding of regulatory requirements, GxP archivists play a major role in facilitating compliance, quality assurance, and the overall success of pharmaceutical operations. A GxP Archivist is not simply a “nice to have” position, according to EU Regulation 536, article 58 a nominated archivist is a “must have”.

What Skills are Required for the Role?

A GxP archivist requires a wide-ranging skillset and a solid foundation in both education and experience. Typically, a bachelor’s degree or higher in fields such as library science, information management, or archival studies is required. Hands-on experience in records management or archival roles is highly desirable for many organisations. In addition to technical proficiency, strong attention to detail, communication skills, and problem-solving abilities are essential traits for navigating the complexities of regulated environments.

Ensuring Data Integrity

One of the primary responsibilities of a GxP archivist is to uphold data integrity. In an era where data is king, ensuring the accuracy, completeness, and reliability of records is essential. GxP archivists implement robust systems and procedures to prevent data manipulation, unauthorised access, or loss. By maintaining data integrity, they safeguard the validity of research findings, clinical trial results, and manufacturing records, which ensures the safety and value of pharmaceutical products.

A Continuous State of Audit Readiness

During regulatory audits and inspections, Life Sciences companies are required to provide comprehensive documentation to demonstrate compliance with GxP regulations. In this instance GxP archivists play a big part in this process by organising and preparing documents for review. Their expertise in document management ensures that auditors and inspectors can easily access the information they need, streamlining the auditing process and minimising disruptions to active trials.

Bridging Operational Silos  

Organisational structures can be quite complex, IT, Quality Assurance (QA), and Clinical Operations each have their own specialised tools and processes however, GxP archivists are the glue that binds these functions together. By bridging the gap between departments, GxP archivists facilitate continuous communication, and ultimately safeguard the integrity of pharmaceutical operations.

Supporting Continuous Improvement

In addition to their regulatory responsibilities, GxP archivists contribute to continuous improvement initiatives within Life Sciences organisations. By analysing documentation processes, identifying areas for improvement, and implementing best practices, they help streamline operations, reduce inefficiencies, and enhance overall compliance. Their insights and expertise enable their organisations to adapt to evolving regulatory requirements and industry trends effectively.

Conclusion

Based on legislation (EU Regulation 536, article 58) and the associated benefits, it’s clear that investing in a professional GxP archivist isn’t just prudent; it’s essential for any Life Sciences organisation striving for excellence and compliance in today’s competitive landscape. The next time an inspector knocks, be confident that having a GxP archivist on your team not only ensures your organisation is prepared to withstand the inspection but it is also well-positioned for future assessments.