Custom Software Development Project

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 FDA 21 CFR compliant 1D gel analysis quantification 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 built into the software help to enable compliance with 21 CFR part 11:

• • Audit trails (21 CFR 11.10(e))
  • Limit system access (21 CFR 11.10(d))
  • Electronic signatures (21 CFR 11, Subpart B)
  • Password restrictions (21 CFR 11, 11.200 (a))
  • Emergency logins (21 CFR 11, 11.200 (3))
  • Version History (21 CFR 11, 11.10 (k))

Integration and Reporting: The company required specific functionality and data output for their analysis and reports. We built an interface that calculated only the essential information needed to analyse their gel images. We then 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.

Why choose TotalLab?

Our flexible, agile approach combined with our decades of industry expertise creating scientific software make TotalLab uniquely qualified for custom development projects within the scientific sector. We are able to generate a streamlined, accelerated software development plan that can drastically shorten your time to market and reduce in-house costs.

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 on product development and free up resource 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 end user maintenance and training.