More about our sector?

this is your place

Why Biotech and Pharma Need GxP for their Digital Transformation Projects Now

Why Biotech and Pharma Need GxP for their Digital Transformation Projects Now

Why Biotech and Pharma Need GxP for their Digital Transformation Projects Now

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!

 

Cristina Fernández

Product Owner

Bigfinite Achieves ISO Certifications: ISO/IEC 27001/27017 for Information Security Management and ISO 9001 for Quality Management

Bigfinite announced that it has achieved certification to ISO 9001:2015 in recognition of its commitment to quality management systems (QMS) and ISO/IEC 27001:2013 for information security management (ISMS) including the extension 27017 which includes security in cloud environments. These certifications validate Bigfinite’s ability to deliver reliable systems that align with industry best practices.
Crystal Black VP of Marketing

The AI World Team and Why it’s Important

At Bigfinite, we are completely aligned with the AI World Team to bring you the best practices and experiences possible where it comes to AI and real information about how it can transform your healthcare initiatives to improve the lives of patients.

JPST Publishes First Study Showing AI Algorithms Can Be Qualified for Regulated Pharmaceutical Manufacturing

Bigfinite announced that a new study, published online in the Parenteral Drug Association’s Journal of Pharmaceutical Science and Technology (PDA JPST), demonstrates that AI algorithms can be qualified for pharmaceutical product and medical device productivity chains. Qualification was achieved using Bigfinite’s GxP-compliant AI software-as-a-service (SaaS) platform.

Bigfinite Announces Additions to Executive Team

Bigfinite, Inc. (Bigfinite), the leading manufacturing data analytics platform company for regulated industries, today announced that Brian Sweeney, Lawrence Baisch and Glenn Griffin have been added to the leadership team.
Crystal Black VP of Marketing

AI Algorithm Qualification

Pharmaceuticals and Biotech companies have no doubt that Artificial Intelligence (AI) is here to stay. Nonetheless, the opportunities AI technology offers are developing at a slow pace in a rather conservative manufacturing industry, aimed at managing production risks under controls that are subject to strong regulations. Fear of change? Risk aversion? Likely not.
Jordi Guitart VP of Artificial Intelligence

Bigfinite Announces Senior Leadership Additions

Bigfinite, Inc. (Bigfinite), the leading manufacturing data analytics platform company for regulated industries, today announced that John Vitalie has been named Chief Executive Officer (CEO) and has been elected to the Board of Directors. David Merino has been named Chief Financial Officer (CFO) of Bigfinite.

Why Biotech and Pharma Need GxP for their Digital Transformation Projects Now

Technological Enhancements with Principal Component Analysis Combined with Artificial Intelligence

Bigfinite Closes Series B Financing with Atlantic Bridge and Honeywell Ventures to Drive Disruption in Manufacturing Analytics

2019 Xavier University AI Summit Reflections – Two Industries Ready for Change

Now that the dust has settled from the Xavier University AI Summit and our team is back to business, we’ve had time to process some of the highlights and key takeaways from the exciting event.  In the past few years, there has been a significant increase in the implementation of digital technologies into various industries that subsequently impacted the way we live, travel, and do business.  From driverless cars to 24/7 customer support chatbots, innovation and technology continue to spiral upward and as we’ve entered the 4th industrial revolution, and healthcare + biopharma should be no exception.  The Xavier University AI Summit is a great event that brings together a range of relevant stakeholders with common focus on artificial intelligence (AI).