How IT and QA departments align around GMP for regulatory excellence

In the Life Sciences industry, compliance with Good Manufacturing Practices (GMP) is not limited to the production floor; it extends deeply into the Information Technology (IT) function. As technology becomes the backbone of manufacturing, operations and quality assurance, IT systems play an essential role in ensuring data integrity, product quality, and patient safety. From managing computerized systems to maintaining validated environments, the IT function’s alignment with GMP principles is critical to the success and compliance of any Life Sciences organization. Understanding how IT integrates with GMP and how it collaborates with Quality Assurance (QA) is key to building a reliable, compliant, and audit-ready system of operations. 

Why Should the IT Department Follow Life Sciences GMP?

Good Manufacturing Practices (GMP) are quality standards designed to ensure that products are consistently manufactured, controlled, and fit for their intended use. While GMP is often associated with manufacturing and laboratory activities, it also applies to the computerized systems that support these processes, making the IT department a key stakeholder. 

In Life Sciences organizations, IT teams design, implement, and maintain systems that manage critical data and support manufacturing, quality, and compliance activities. When these systems are not properly controlled, risks such as data integrity issues, system failures, or security breaches can directly impact product quality and patient safety. By following GMP principles, IT ensures that systems are reliable, accurate, secure, and fit for regulated use. 

From a regulatory standpoint, authorities, including the Food and Drug Administration (FDA) and the European Medicines Agency (EMA), expect computerized systems used in regulated environments to meet specific requirements related to validation, data integrity, access control, and change management. Systems need to be fit for their intended use throughout their lifecycle. This includes validated functionality, controlled access, traceable changes, and secure, reliable data handling.  

Adhering to GMP helps IT departments align system design and maintenance with these expectations, reducing the risk of non-compliance during audits or inspections. Ultimately, GMP provides a structured framework that enables IT to proactively manage risks, maintain system consistency over time, and support the organization’s broader quality and compliance objectives. 

How Can QA and IT Departments Align Their Activities Around GMP? 

Effective GMP compliance depends on close collaboration between QA and IT. While their responsibilities differ, their goals are closely aligned when it comes to information technology used in manufacturing: ensuring that computerized systems consistently support product quality and regulatory compliance. 

Successful alignment is built on several practical foundations:

• Defined roles and accountability 

  QA is responsible for defining quality and compliance expectations, while IT is responsible for technical implementation and system operation. These roles must be clearly documented and consistently applied across system lifecycles. 

• Clear and regular communication  QA and IT should maintain ongoing dialogue through scheduled meetings and defined communication channels. This ensures transparency around system status, risks, deviations, and upcoming changes. 

• A shared understanding of GMP requirements  Both teams must clearly understand which GMP requirements apply to computerized systems, which specific systems are subject to those requirements, and how those requirements translate into practical controls, documentation, and system behaviors. 

• Joint planning and risk management  QA and IT should collaborate early in system planning to assess risks, define validation scope, and determine documentation and testing requirements. Early alignment prevents rework and gaps later in the lifecycle. 

• Coordinated system validation  Validation activities should be planned and executed collaboratively. QA defines expectations and oversight, while IT ensures technical implementation and testing align with the agreed validation approach. 

• Controlled change management  Any changes to GMP-relevant systems must be assessed, documented, tested, and approved. QA and IT must work together to ensure changes do not compromise the validated state of the system. 

• Ongoing training  Both departments should receive continuous training on GMP, data integrity, and system lifecycle management to stay aligned with evolving regulatory expectations. 

  
  

When QA and IT operate as partners rather than separate functions, organizations are better positioned to maintain compliant, reliable, and well-controlled computerized systems. 

Who Oversees System Validation in a Life Sciences Company? 

In a Life Sciences organization, system validation oversight typically sits with the Quality Assurance department. QA is responsible for ensuring that computerized systems comply with regulatory requirements and are suitable for their intended use. It defines the overall validation strategy, including scope, approach, acceptance criteria, and documentation requirements. This strategy ensures consistency and regulatory alignment across systems. 

The IT department is responsible for executing the validation activities in line with the approved approach. This includes system configuration, technical testing, issue resolution, and maintenance of system documentation. Throughout the process, QA provides oversight by reviewing execution, verifying compliance with quality standards, and approving validation deliverables. 

Once a system is validated, responsibility shifts to maintaining that validated state. QA governs change control and periodic review processes, while IT ensures stable operation, controlled updates, and ongoing technical support. Validation is therefore not a one-time event, but a continuous state jointly maintained by QA and IT. This shared responsibility is essential for long-term compliance. 

Is It Important to Have an External Advisory for System Validation?

Engaging external advisory during system validation can add significant value, particularly for complex systems or organizations with limited in-house expertise. Independent experts can challenge assumptions, identify blind spots, and confirm that validation approaches align with current regulatory expectations and industry practices.

External advisors can provide: 

• Objectivity: an objective perspective on the validation process, which can help ensure that the validation is performed in a rigorous and unbiased manner.  

• Expertise: specialized knowledge and expertise around system validation, which can help ensure that the validation is performed in accordance with the latest industry standards and best practices. 

• Experience: experience from previous validation projects, which can help identify potential risks and pitfalls in the validation process and provide insights into how to avoid them.  

• Cost-effectiveness: cost-effective support during the validation process, as they can bring a focused and efficient approach to the project and help ensure that the validation is completed on time and within budget. 

• Regulatory compliance: an independent assessment of the validation process, which can help ensure that the company is following regulatory requirements and compliant. 

  
  

That said, the decision to involve external advisors depends on organizational needs, system complexity, and internal capabilities. Some companies successfully manage validation internally, while others benefit from targeted external support. 

In conclusion, strong collaboration between the Information Technology (IT) and Quality Assurance departments (QA) under the GMP framework is essential for maintaining compliant and reliable computerized systems in Life Sciences organizations. Computerized systems are central to regulated activities, and their reliability, security, and integrity depend on GMP-aligned IT practices. Clear ownership, strong QA–IT collaboration, and lifecycle-based system control are essential to maintaining compliance and inspection readiness. When these foundations are in place—and supported by external expertise where appropriate—organizations are better equipped to manage regulatory risk while enabling digital innovation. From an IT and QA standpoint, GMP is not a constraint on technology; it is the framework that allows technology to be used with confidence in a regulated industry.