Case Study: Building a 21 CFR system for a global pharma database
A world-leading pharma company in the immunotherapy field approached us to help them develop a custom 21 CFR-compliant database for 1D gel analysis data and migrate a large existing dataset they already had onto that platform. They also required a custom reporting tool to fully automate their report generation within the software rather than relying on exporting data manually to a Microsoft Word template.
Deliverables: A complete 21CFR compliant 1D gel analysis solution and a proprietary database to store and index the data for further analysis and the import of a large existing database with no loss of data.
How our Software Helped Their Business
21 CFR Part 11 Compliance: Key implementations we built into the software help to aid compliance with 21 CFR part 11. These are as follows:
- Audit trails (21 CFR 11.10(e))
- Limiting system access (21 CFR 11.10(d))
- Electronic signature configuration (21 CFR 11, Subpart B)
- Password restrictions (21 CFR 11, 11.200 (a))
Integration and Reporting: The company required specific functionality and data output for their analysis and reports. We built an interface that calculated the essential information needed to analyse their gel images. We created a new reporting system to enhance and automate their gel reports, reporting only the meaningful results they required and in the format they wished.
GxP Data Migration: We generated a seamless data transfer from the old system to the new, efficient 21 CFR-ready solution, allowing ready-to-retrieve data sets.
What are the benefits of bespoke software development with TotalLab?
Our flexible and agile approach, coupled with our technical and industry expertise, generates a streamlined and accelerated bespoke software development process.
You don’t need to know what the solution is, we can work on what it looks like. You just need to present the challenge or issue you’re looking to resolve and we can develop the rest.
This approach enables you to keep your focus in-house whilst we develop a customisable solution that can easily integrate into your existing infrastructure and processes, and provide you with software that can scale as necessary. You can also benefit from our technical support for maintenance and training.