Build secure, compliant IT foundations for regulated systems.

A growing biotech company wanted to answer a practical manufacturing question: Why are some batches taking longer than others? The information needed to investigate the question already existed. Manufacturing information was in the Manufacturing Execution System (MES). Process conditions were captured by a historian. Laboratory results were in the Laboratory Information Management System (LIMS). Quality

A biotech company may already have the data it needs to answer an important question. The problem is that the answer may be spread across five different systems. Consider one batch. The MES knows what happened during execution. The historian captures process conditions. LIMS contains laboratory results. The eQMS holds deviations and investigations. ERP contains

Auditing IT infrastructure in a GxP environment means checking whether the technical foundation behind regulated systems is controlled, supportable, and appropriate for its intended use. The audit should not stop at servers or network diagrams. It should test whether access, changes, backups, monitoring, and supporting services are managed in a way that protects system reliability

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

Every company experiences periods of either rapid expansion or uncontrolled growth that hinders IT’s ability to keep up with demand or scale fast enough to sustain the business. We can all admit: Change is inevitable and challenging, but with the right forewarning, leadership, and foundational planning; Companies can mitigate issues and build a stable infrastructure

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

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

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

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.