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

Applications / Use cases / Management of the laboratory Equipment Moving Process

Use case

Management of the laboratory Equipment Moving Process

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

Download the practical sheet
Visual of people taking inventory in a warehouse

Context of the digitalization request

Our client, a sizeable French laboratory operating worldwide, wants a solution to manage the move of equipment from several laboratories to a single new building.

To manage the different steps of these transfers, our client wants to replace Excel files with a complete, intuitive, and easy-to-use tool. The project started in 2019 and is expected to end in 2024.

GxpManager embarked on this project by creating a GxpXL mock-up and participating in defining the process to be implemented to manage equipment transfers.

The working group set up was made up of less than 10 people to represent the different actors of the moving process.

Challenges

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

This will allow defining a simple and fluid tool by avoiding the implementation of workflows, for example. The solution must allow, through various and powerful indicators, to efficiently manage the different activities. It must facilitate the traceability of equipment with labels that include an identifier and information on the origin and destination.

The data entry forms must limit the manual entry of information to promote standardization and errors (data integrity). In addition, they are optimized to facilitate the entry of the numerous information associated with the equipment.

The application must be able to integrate information from SAP in a punctual way.

The application solution

Implementation of the GxpXL offering was carried out in 2 sessions and allowed the build of a mock-up of the expected application.

The project was scaled in 3 sprints over 3 months during the lockdown. During the sprints, the key users could align the vision of their needs with the possibilities of the GxpXL platform, then test and evolve the application according to the feedback.

The application allows the equipment to be grouped into batches and tracked from its start location to its end location.

GxpXL
Bespoke application

Digitalization of Excel® files and Other Spreadsheets

More information

The application complies with the requirements and recommendations applicable to electronic records, electronic signatures, and computerized systems: FDA 21 CFR part 11, GMP Annex 11, GMAP 5.

GxpManager has developed a platform that integrates powerful functionalities: traceability, security, flexibility, reporting, and analysis. It allows you to create (without coding) customized compliant applications in response to your issues and needs.

The application fits your business logic and respects your organization and your processes.  Together with you, we study your needs and translate your business processes into applications. Thanks to its “super agile” generator, users are more involved in creating, evolving, and permanently enriching applications

Results

The application allows the client to:

  • Gain in productivity
  • Optimize the monitoring of equipment and batches
  • Facilitate the entry and research of information concerning a batch or equipment
  • Trace all modifications/deletions/creations of information thanks to the audit trail
  • Extract data in standardized and controlled formats
  • Manage mandatory information entries
  • Exploit the data entered to edit reports in Word or PDF and Excel format, depending on the rights
  • Secure access to the application and its content in a precise manner
  • Have an outline and indicators of the activity
  • Have an overview of the moving activities
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
Cell culture service digitization

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

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
Digitize Paper Forms

Digitize more than 1000 paper forms without altering the content and signature processes...

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
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