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

Applications / Use cases / Digitize Paper Forms

Use case

Digitize Paper Forms

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

Download the practical sheet
Visual of a man entering a web form

Context of the digitalization request

Our client, a worldwide biotechnology drug maker, was facing paper forms multiplication.

These forms are used to collect data, or follow a quality assurance process (e.g: change control). These forms were printed, signed, distributed, and then archived.

This client, began a project to go paperless and to digitize its forms in 2018. It selected the GxpManager solution with its GxpForms application to digitize its paper forms on two pilot sites.

Challenges

Digitize over 1000 paper forms without altering the content and signature processes, without burdening users, and when possible, by simplifying the process.

Today, paper forms found in regulated industries can lead to non-conformities related to data integrity issues. They are also time consuming and environmentally unfriendly.

The application solution

Implemented the bespoke application “GxpForms” in collaboration with the client, so that users could create, fill out and track form with electronic signatures and with ease.

Thanks to its agile and Low Code/No Code configurator, the client and users were more involved in the creation and the enhancement of their applications.

All of this while respecting industry regulations and keeping the forms’ integrity.

GxpForms 

Custom digitalization of forms

More information

The application complies with various international regulatory authority: EMA, FDA, GMP, ISO.

GxpManager has developed a platform that integrates powerful features: 21 CFR Part 11 compliance, 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.

Results

The Application allowed the client to:

  • Store / archive digitalized forms
  • Manage mandatory information entries
  • Control the version of the forms
  • Gain in productivity thanks to mastered validation and signature path
  • Electronically sign forms from the workstation (less travel)
  • Trace all modifications/deletions/creations of information thanks to the audit trail
  • Use the data entered in reports in Word, PDF or Excel format
  • Create performance indicators for forms monitoring

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
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
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