Design a Secure and Compliant Data Management Architecture in GxP Environments

In GxP environments, such as pharmaceuticals, biotech, and food industries, strict regulatory compliance and data integrity make robust data architecture essential.  Here we delve into: effective folder structures, permission management, and user account controls are critical to ensuring security and compliance.  Using Active Directory (AD) groups over individual access levels simplifies management, while regular permission

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Infrastructure Qualification: Ensuring Fit for Use Through Change Control, Testing and Continuous Improvement

Infrastructure qualification is a critical process in ensuring that equipment, systems, and facilities are fit for their intended use in regulated industries, particularly in pharmaceuticals and biotechnology. The process involves rigorous testing, change control, and extensive documentation to meet compliance standards and ensure continuous improvement.  This blog will break down the stages of Infrastructure Qualification

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The Silver Lining: Cybersecurity Breaches in Pharma and Biotech Drive Innovation and Resilience

Since the first major pharmaceutical breach reported in 2017 by Merck Sharp and Dohme, cyber attackers have increasingly targeted the biotech and pharmaceutical sectors. The strict regulatory compliance required in these industries creates complex digital environments, making them attractive and vulnerable targets for cyberattacks. Within a few years after the COVID-19 Pandemic, where digital transformation

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Network Design for Biotech Sites: Balancing Isolated vs Secure Networking Designs

Network design has always played a critical role in ensuring seamless operations in Biotech.  However data security and reliable communication are often at odds with each other.  Sites, which include laboratories, research facilities, and manufacturing plants, demand specialized network infrastructures to support their research, maintain sensitive data, and a myriad of sophisticated manufacturing equipment.  This

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Cell and Gene Therapy Distributed and Point-of-Care Manufacturing: Building Infrastructure and Capacity

Hear from our Co-founder, Krisha Patel, and CEO of Cellular Origins, Edwin Stone as they discuss the current challenges in building infrastructure and capacity for cell and gene therapy in this panel hosted by Carol Houts, CSO at Germfree. ? ? Key Discussions:? The use of automation tools and robotic solutions that support scale-up activities.

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