Context
Challenge
Solution
Results
Used Application
Context
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.
Challenge
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).
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.
- 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.
Used Application
Bespoke stock management application
Fonctionnalités Clés :
- Traceability (Audit Trail)
- Workflow
- Electronic Signature
- Versioning
- Email Notifications
- Import and Export In One Click