Beam Therapeutics

Paul Rascoe

Change Governance Advocate

Driving changes in IT without a quality mindset is no longer sustainable. In the modern life sciences environment, quality is not a checkpoint at the end; rather, it is a lens through which all change must be viewed from the beginning.

Technology is advancing rapidly, in many cases faster than traditional IT approaches can keep up. Life science companies are embracing advanced tools like AI, machine learning, and robotic process automation (RPA) to transform core operations. These innovations, on one hand, promise faster delivery, greater efficiency, and lower costs. On the other, they introduce new risks to product quality, data integrity, and regulatory compliance. In this new landscape, IT teams can no longer focus solely on functionality and scalability.

During the investigation of a new system—or the identification of a needed change—the principles of SISPQ (Safety, Identity, Strength, Purity, and Quality) must remain at the forefront. These attributes define the integrity of regulated products and are essential to protecting patient safety. IT system architects must look beyond core functionality and evaluate how proposed changes may influence quality. This includes determining whether validated states could be impacted, whether control of quality data might shift, or whether GxP workflows could be unintentionally disrupted. Keeping SISPQ central from the outset ensures that technology changes reinforce, rather than weaken, the quality system.

A core tool for ensuring quality is at the heart of an IT-managed change is the use of a risk assessment. Risk assessments have long been used as a tool in project management toolboxes. For IT risk assessments, the focus has been a tactical one, primarily focusing on IT system impacts such as disruptions, operational concerns and system performance. The risk assessment's scope needs to be broadened to also identify how the system change may affect quality. This evaluation should include impacts to validated states, data integrity, and control over quality impactful workflows. When IT teams adopt this lens, the risk assessment becomes a practical mechanism for integrating quality into technical decision-making, shifting it from a compliance afterthought to a proactive safeguard built into the change process.

There is a delicate balance that needs to be struck between innovation and quality, and therein lies the deeper thought that is required for managing IT changes. ERP systems are growing monstrosities that mix and interweave GxP with non-GxP data and processes. An example of this is the receipt of critical components into a warehouse where they are labeled and placed into temperature-specific storage bins. If a system change is proposed to modify how the receipt of material is entered into the system, does that have an impact on the product with changes to label generation (SISPQ; Identification)? Or is it only a financial change impacting when the system is notified to pay the vendor (Non-GXP)? It is here, though, that needs quality-minded IT people the most. Similarly, moving the material in the warehouse from 1 storage bin to another, such as occurs when a pallet is mostly consumed and it makes more sense to store the remaining material on a shelf instead. Does this have an impact on the product due to the temperature control requirements of the material needing to be followed (SISPQ; Strength)? Or are we just moving the material and allowing previously placed system controls to address any attempts to place the material in a location it should not be placed in? These 2 examples demonstrate why IT not only needs to know how the system works but also be thinking about possible SISPQ impacts resulting from the change.

In life sciences, system changes are no longer just technical exercises; they are quality-critical decisions. Leading with a quality mindset ensures new technologies serve their purpose without compromising what matters most: the patient.