How to build and implement an eQMS: efficiency, compliance and data integrity – Replay

Applications / Use cases / Biological samples traceability

Use case

Biological samples traceability

Implementation of a custom stock management solution to trace all operational information from reception to delivery, including product destruction.

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image of a biological sample

Context of the digitalization request

Our client is a company specialized in biobanking (management of biological and chemical samples): reception, preparation, preservation, transportation, and destruction. As a service provider for science entities (R&D laboratories, quality control, clinical studies, bioproduction, etc.), our client adheres to regulatory requirements in the Life Science sector.

This company aims to move towards an application solution to handle product traceability and eliminate paper, which is a source of errors and incomplete information affecting quality.

Challenges

Our client needs a custom stock management solution to trace all operational information from reception to delivery, including product destruction.

The solution must:

  • Enhance product traceability through product sheets, enabling location management.
  • Ensure the integrity of recorded data.
  • Comply with increasingly stringent regulations in the Life Sciences sector, especially temperature controls for biological samples and the 21 CFR part 11 standard, which imposes criteria for computerized systems (access control, electronic signatures, electronic records).

The solution should be scalable to adapt to future adjustments or the integration of new processes.

The application solution

Implementing a tailor-made GxpManager solution currently allows our client to:

  • Manage arrivals: assigning a batch number, breaking down the package into storable components. Empirical forms enable checking product quality and ensuring package completeness. Check and countercheck signatures are now electronic.
  • Manage product storage and destocking: Managing locations by changing the product and location status.
  • Traceability: each step is traced and assigned to an operator through electronic signatures.

Bespoke Application

GxpManager

More information

Native functionalities of GxpManager applications:

  • Audit trail: tracking all modifications to ensure data integrity.
  • Electronic signature.
  • Workflows: to facilitate process advancement.
  • Versioning: preserving the history of previous versions.
  • Access management: creating user profiles with different levels of rights (read, write, delete, or execute).

Results

  • Elimination of paper in stock management processes: checking is now complete and not prone to errors or incomplete information compared to paper use.
  • A time saving of 20% in stock management. Regulatory compliance, especially for monitoring the maintenance of certain products at a fixed temperature.
  • Process optimization with a productivity gain of 27%.
  • Traceability of all actions and data, easing audits.
  • Data security and integrity.
  • An agile solution: a first evolution of the current solution is in production, and a second one is pending. New processes will also be implemented.

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