The promises of what a digital transformation can bring are new and exciting but also challenging and complex. For pharmaceutical and biotech companies, the use of digital technologies may be challenging and more complex due to their knowledge of how digital technologies work and the possible impact it could have on patients. The industry is still looking for the best standard for its digitalization strategy, looking for a secure plan due to strict regulations and GxP compliance.
As we look to the future of pharmaceutical and biotech industries, novel digital transformation technologies such as artificial intelligence, deep learning, and machine learning will absolutely play a part in their growth, success, and ability to stay afloat in the growing, competitive market. It’s no secret that the industry is facing pressure to innovate due to an increase of personalized medicine, stricter regulations from the FDA, and competition creating a need for faster time to market. So as the Pharma 4.0 shift begins to take place, GxP compliance, data integrity, and regulations is something that needs to be considered when creating a digital strategy.
Why is GxP compliance important?
- Regulations become more strict due to personalized medicines, gene therapies, etc.
- “Early choices matter” – starting with a GxP compliant platform will allow you to project the cost of your projects. Knowing the cost from the beginning will allow you to budget correctly
- Understand your processes better and have unlimited possibilities with a GxP platform. Starting with a GxP platform earlier will allow you to see your manufacturing site holistically, allowing you to better understand your processes and make improvements if need be. This will also keep you from having to go backward in a project if you need a platform that is GxP compliant
- Also, the MHRA (Medicines and Healthcare products Regulatory Agency) in the UK established a GxP Data Integrity Guidance for cloud providers including Software-as-a-Service, Platform-as-a-Service, and Infrastructure-as-a-Service
- And the FDA (Food and Drugs Administration) has incorporated cloud technology into their Emerging Technology Team recognizing that it will influence how quality systems will be assessed by the FDA
An effective and successful digital transformation can bring a magnitude of benefits, improving speed and efficiency while maintaining compliance. Ultimately, the most important goal is to provide better treatments for patients and as regulations become more strict, companies must consider GxP compliance and ensure data integrity when creating and executing their digital strategy and culture. At Bigfinite, we consider ourselves to be enablers of Pharma 4.0 and inspirers of AI in regulated environments. The Bigfinite platform was born from the new digital technologies with a unique focus on Life Sciences and specifically pharmaceutical and biotech manufacturing.
Learn more by joining us for a webinar, Why Biotech and Pharma Need GxP for their Digital Transformation Projects Now, on March 9, 2020!