Our clients, global drug producers, are now faced with the burden of paper forms and their tracking in Excel.
Paper forms, present in regulated industries, generate non-compliance with data integrity regulations. They are also time-consuming and environmentally unfriendly.
The Master Data management process is an upstream activity of information system solutions (ERP, MES, LIMS…).
Digitize the collection, verification, and approval of Master Data.
The MDM is the master data of your business processes. Paper forms (PDF templates) are most often used for data collection, verification, and approval, in addition to Excel files. However, they no longer correspond to the level of compliance and, therefore, to the maintenance of data quality, data integrity, or security required by our customers in a highly regulated environment.
The solution was implemented with the GxpForms application.
Based on the paper and PDF forms, as well as the Excel tracking files provided by the clients, the consultants have designed applications that replicate the Master Data Management process of our clients. Allowing the centralization of data in a single point to simplify the organization and ensure data integrity.
The application allowed the client to:
- Store/archive forms electronically
- Manage mandatory information entries
- Control the version of the forms
- Increase productivity thanks to controlled validation and electronic signature
- Electronically sign forms from your workstation or from home (remote)
- 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 monitoring forms
In short, thanks to this custom-made application that was implemented in record time, users can follow the process of creating or updating Master Data in a dematerialized and simple way.
GxpForms is an application that complies with the requirements of various international regulatory bodies: 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 using our no-code configurator.
Thanks to its super agile generator, users are more involved in the creation and enrichment of their applications.
More informationThe applications are made available as SaaS to optimize the speed of implementation, immediate integration, flexibility, and administration of the delegated infrastructure.
All operations of updating, backup, restoration, and archiving are automated.
Cloud data is hosted in France in 2 highly secured Data Centers certified ISO 27001: 2013.