Software systems deployed in regulated environments (manufacturing or clinical labs) within the pharmaceutical industry are subject to rigorous validation to ensure output of these systems are reproducible and accurate, known as GxP in line with GAMP5 guidelines.
Our approach to compliance and data governance is central to our core mission to improve the outcome for patients by improving the drug creation process with the effective and accessible use of data and analytics. In order to do that effectively, we must be certain that our products are built to the highest possible standards. We go beyond industry best-practice and creatively innovate internal technical solutions to streamline and accelerate our adherence.
We have developed new technology to structure all stages of the software-development lifecycle to enable the automated collection of documentation and evidence to support the accreditation activities and the generation of documentation for the technical file which is passed to our customers.
This enables our customers to deploy the Aigenpulse Platform in the regulated environments such as cell and gene therapy manufacturing sites or regulated clinical laboratories.
Compliance with 21CFR11
To ensure that the Aigenpulse Platform can be used within an FDA regulated environment, it must be set up in accordance with the FDA CFR 21 part 11 regulation.
The Aigenpulse Platform is installed as a closed system. ‘Closed systemʼ refers to a situation where the access to the system is controlled by persons who are responsible for the content of electronic records that are on the system.
For the purpose of the Aigenpulse Platform, the CFR 21 part 11 covers two areas:
- Electronic records: This relates to the data which is stored and managed within the system, i.e.: any data uploaded to the Aigenpulse Platform. It imposes requirements on the system to ensure the electronic data can be used in lieu of paper documents.
- Electronic signatures: This relates to how people can electronically sign documents and forms (i.e. data analytics actions), with the purpose that these electronic signatures substitute paper signature (aka ‘wet signatures’).
The Aigenpulse Platform has been built specifically for the life sciences market, with regulation in mind.
Supporting your compliance
Because scientists in biotechnology and biopharmaceutical organisations trust our products to process, analyse and present their data and results, it’s our responsibility to repay this trust with guarantees that:
- Their data is safe and private
- The processing and analyses are accurate
So, when using our Platform in your organisation, whether in R&D or GxP environments, you can be confident that it was built in line with, and performs to, the highest standards.