Solving data integrity challenges in the pharmaceutical industry

05 July 2019

Data integrity is the current buzz term in the pharmaceutical industry. It has been an area of importance for many years, but recently, the focus has very much been on how data integrity is managed in the laboratory. Some reports show that the number of warning letters and statements of non-compliance with GMP citing data integrity issues has tripled since 2013. This has led to the FDA and MHRA, amongst others, to release industry guidelines on data integrity.

While these guidelines go some way towards supporting users working in the industry, it does not solve the problems associated with managing legacy systems not necessarily designed to meet the latest guidance on data integrity. This is creating problems for the lab where additional work is required to cover the gaps identified.

If we look at environmental monitoring handling and data management, the latest data integrity issues highlight significant shortfalls in this age-old manual process. Andy Hopkins once stated at a Pharmig meeting that operators working in the lab will either have to have all samples double checked to verify results or take a photo of every plate to maintain a complete and verifiable record. This would be both costly and resource-heavy for any business to manage. While alternative solutions to direct labour do exist, they require significant upfront capital expense, ongoing maintenance and licensing requirements and in some cases, may require a significant footprint to be accommodated in the laboratory. This is not always a satisfactory solution for pharmaceutical companies with limited QC budgets. It also does not guarantee itself as a long-term solution in our rapidly changing world.

There are, however, some suppliers out there trying to resolve these issues, maintain affordability and ensure long term viability for the lab while embracing cloud-based computing and artificial intelligence.

Microgenetics have developed a cloud-based software solution for the management of environmental monitoring data. SmartControl is an easy to use, paperless system that seamlessly captures an image of every plate. The software has built-in quality checks on any images captured to ensure an accurate record, with plans to leverage machine learning to cross-check the number of CFU identified by an operator. Microgenetics offer an affordable monthly subscription service with no upfront costs.

This software uses the latest technology to solve the data integrity problem in the following ways:

  • Seamless image capture: when plates are read, the user captures an image of the plate. Inbuilt quality checks ensure the image is in focus and completely in the frame, as well as that the image is not a repeat of a previous image. This image is forever stored against the record for reference or spot-checking at a later date.
  • Uniquely identifies each plate: through the use of barcode scanning, it is possible to ensure that the data being recorded against a sample is unique to that particular sample and sample image.
  • Cloud-based computer system: with computer-based systems, it is possible to ensure that all activities are recorded with a date and time stamp in an easily legible manner. Cloud-based computing makes that data available at the click of the button in real-time, ensuring you are always using the most up to date version of the data.
  • Unique logins: users can only access the system using their unique credentials. Once logged into the system, any activity performed by that user will be recorded in the audit trail and against the records being created.

Data integrity can be a challenge to overcome, but through adopting smarter technological solutions such as SmartControl, you can ensure you always have the latest, pre-validated version of the software at your fingertips helping you keep your lab on top of data integrity requirements.