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

Applications / Use cases / Cell culture service digitization

Use case

Cell culture service digitization

The application enables the planning of cell cultures and ensures the traceability of each associated action.

Download the practical sheet
Digitalization of a cell culture service with GxpManager bespoke application

Context of the digitalization request

Our client is an international pharmaceutical company operating in the human and animal health market.

In the highly regulated healthcare sector, ensuring the security and traceability of critical data is now essential to comply with various standards (ISO, 21 CFR Part 11…).

Our client aims to move towards a custom solution, GxpManager, to ensure the traceability of its cell culture service.

Challenges

By moving away from the manual methods used so far (paper and Excel® spreadsheets), our client aims to ensure the integrity of the generated data and thus the regulatory compliance of its cell culture service. Regulatory compliance is a priority for this Life Sciences sector company. Our client must notably comply with the 21 CFR Part 11 standard, which imposes criteria that computerized systems must meet (access control, electronic signature, electronic records) to ensure data security and integrity.

The solution must be scalable and adapt to future changes in internal procedures and external regulations.

The solution must be able to integrate with external software, particularly with cell count calculation automates, on significant exchange frequencies.

The application solution

The GxpManager application solution must ensure the traceability and integrity of data from the various processes of the cell culture service:

  • Order listing management: the solution must be able to integrate with an external system managing cell requests.
  • Stock management: Receipt, labeling, storage, and removal of cells with location management.
  • Culture medium preparation: culture sheets, labeling, storage…
  • Planning of cultures and all associated tasks using a retroplanning approach (based on a GANTT chart) so that cells are delivered in the right quantity, quality, and time: medium preparation, cell thawing, culture duration, passages…, each task must be planned and traced.

Bespoke Application

GxpManager

More information

Native functionalities of the GxpManager platform

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

Results

  • Regulatory compliance achieved for the cell culture service: traceability of all tasks, data security, and integrity ensured.
  • An agile solution capable of adapting to changes in service, company, and regulations. The solution can also be configured for other services to digitalize other company business procedures.
  • A 40% reduction in human errors, notably due to the automation of activity planning.
  • A tailor-made solution delivered and qualified within 6 months.

Other use cases

Use cases
Air Transport Regulatory Compliance Solution

Discover how an international airline carrier streamlined regulatory compliance by replacing Excel® with a GxpManager application. Achieve improved productivity, simplified audits, enhanced quality management, and better collaboration. Download the practical sheet for more insights.

Learn more
Use cases
Custom application development for equipment and process qualifications/validation

The custom application's configuration took only 12 days. It allows for the planning and tracking of equipment, as well as manufacturing process qualification and validation activities.

Learn more
Use cases
Quality Management System for a pharmaceutical logistics company

The application enables simplified management of quality processes and regulatory compliance with 21 CFR part 11

Learn more
Use cases
Biological samples traceability

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

Learn more
Use cases
Artworks: Management of packaging items and promotions

Management and validation of Artwork in-house up to the publication for the printer (subcontractor) for an international pharmaceutical company, with a 20% time-saving in validation.

Learn more
Use cases
Client Case Merck®: Digitalization of Forms

Discover how Merck optimized productivity and compliance with GxpManager's no-code platform, saving over 6,000 hours annually by digitalizing critical processes like batch release and form management. Simplify workflows, ensure data integrity, and enhance efficiency.

Learn more
Use cases
Master Data Management (MDM)

Digitize data collection, verification, and approval to centralize it in the Master Data Management (MDM).

Learn more
Use cases
Management of the laboratory Equipment Moving Process

Identify all the steps required to move equipment and structure an associated project management approach.

Learn more
Use cases
Inventory management of computerized systems equipment

Create a regulatory-compliant application that facilitates the inventory process management of the computerized systems, suppliers, and equipment.

Learn more