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How a GLP Facility Can Go Digital in a Compliant Manner

By Jackie Torfin, QRxPartner

We recently completed a workshop on How a GLP facility can go digital in a compliant manner at a large multinational company. The 3-day workshop, led by Jackie Torfin and Brendan Hyland, started with a learning session to level-set the company’s stakeholders, then continued with a process-by-process deep dive assessment, ending with an implementation path forward with quick wins and longer-term potential gains. It went well, and the participant feedback was that it has helped unblock their modernization / global alignment efforts.

For a GLP (Good Laboratory Practice) regulated company, going digital means adopting and implementing digital technologies and solutions in their operations and processes. This transition to digital systems and tools can have different implications for a GLP-regulated company. For a typical GMP (Good Manufacturing Practice) based company, the data supports the product; but in a GLP-regulated study, the data IS the product. This gives some GLP compliance professionals a little anxiety over making the move. In addition, the GLP regulations are fairly silent on using digital strategies and, therefore, can be wrongly interpreted as not allowing them. However, this isn’t true.

Before jumping in and digitizing everything, here are a few key points to consider:

Electronic Data Management: Going digital involves digitizing and managing laboratory data and records electronically. This includes electronic data capture, storage, and retrieval of study-related information, such as raw data, study protocols, standard operating procedures (SOPs), and quality control documentation. It typically replaces traditional paper-based systems, enabling more efficient data management and reducing the risk of errors or loss of information.

Laboratory Information Management Systems (LIMS): GLP-regulated companies can implement LIMS to streamline their laboratory workflows, data tracking, and sample management. LIMS software allows for automated data entry, sample tracking, instrument integration, and result reporting, improving overall data integrity, traceability, and compliance with GLP guidelines.

Electronic Document Management Systems (EDMS): Digital transformation involves adopting EDMS platforms for managing and controlling documents related to GLP studies. This includes SOPs, study protocols, study reports, and other relevant documents. EDMS ensures version control, document access control, audit trails and facilitates collaboration among stakeholders while maintaining compliance with GLP regulations.

Instrument Integration and Automation: Going digital often involves integrating laboratory instruments and devices with data management systems. This integration allows for the direct transfer of instrument-generated data into electronic formats, reducing manual transcription errors and improving data integrity. Automating certain laboratory processes, such as sample handling, data analysis, and report generation, can enhance efficiency, reproducibility, and compliance with GLP requirements.

Quality Management Systems (QMS): Digital transformation can also impact a GLP-regulated company's QMS by enabling digital tools for managing deviations, corrective and preventive actions (CAPAs), change control, and training records. A digital QMS can enhance compliance, traceability, and efficiency in managing quality-related activities within the organization.

Data Security and Compliance: When going digital, GLP-regulated companies must ensure robust data security measures and compliance with relevant regulations, such as data integrity requirements, electronic signature regulations, and data privacy laws. Implementing appropriate data encryption, access controls, user authentication, and audit trails are essential to protect data integrity and maintain compliance with GLP guidelines.

Going digital for a GLP-regulated company can bring significant benefits, including improved data integrity, enhanced efficiency, streamlined processes, better traceability, and increased compliance with regulatory requirements. However, it also requires careful planning, validation, and training to ensure a smooth transition while maintaining the highest standards of GLP compliance.

If you’re interested in learning more about the process for moving in this direction, whether for a GLP or GMP facility, QRx Partners can help. 833-779-7278

LinkedIn @QRxPartners

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