Integrity & Security
BENEFITS OF A STRUCTURED FRAMEWORK
Heavy reliance on documents, spreadsheets, and quality management systems to store the vast amount of information generated during the lifecycle of a product leads to critical data quickly becoming buried in documents and dispersed in myriad reports, file servers, email systems, etc. The longer-term consequences are poor process understanding and challenges to tech transfer leading to under-developed products that ultimately affect product quality.
The fundamental problem encapsulating many of these issues is the persistence of unstructured data frameworks. If you accept this thesis, then the obvious answer is to structure the data. However, what is not so obvious is HOW to structure the data.
Download our whitepaper on structured frameworks for Pharma 4.0.
Structured repositories enable automation. Automation of data entry, complex workflows, analytics, reporting, compliance and more. When you know exactly where you need to put your data, you are more likely to do so and more likely to see the data you are missing.
QbDVision is a structured repository tailored for the pharma and biotech industries that automates knowledge and quality risk management and enables the best practices of Pharma 4.0 under the principles of quality-by-design and data integrity by design.
Virtualized life science companies have team members spread out geographically, often all over the world. Whether you are evaluating cause and effect relationships, process risk assessments, or control strategies, being able to quickly access and share information interactively is critical to the elimination of silos. As silos get removed, transparency and visibility improve across the organization. More importantly, Institutional knowledge is captured in one, controlled environment so that as people come and go, critical process understanding is not lost.
Data Integrity & Security
With more and more information stored electronically and in the Cloud, digital data integrity and security have become critical concerns for companies with highly proprietary information. These concerns are just as important for regulators trying to ensure the accuracy and consistency of the information they rely on to make their decisions about safety, efficacy, and product quality.
QbDVision was built with these requirements in mind. All activity is logged in version-controlled audit trails. Once information is entered into the system, whether it is directly or through imports, it can be archived but never deleted. Our solution is built on the AWS platform and we employ best practices to ensure your data is secure.
The list of compliance requirements continues to grow every day whether it relates to drug development, software validation, or data privacy and security. The QbDVision application is built so that the mere act of using it facilitates compliance with the quality guidelines of ICH and ISO, the data integrity requirements of 21 CFR 11 and EU Annex 11, and the development principles of holistic quality-by-design.
With a serverless architecture that allows for rapid production scale testing, the traditional, lengthy cycles of IQ, OQ, and PQ are gone. The serverless paradigm means that the application is served from the cloud and installation is effectively instantaneous. Add to that the novel automated and validated testing tools we are using and software revisions can be tested in a matter of hours.