The Essential IT Guide for GxP Environments: How to Ensure GxP Compliance with Your IT Infrastructure

Vlad Tsyrlin

While this article may not constitute a comprehensive "guide" in the strictest sense, it offers seasoned advice drawn from over two decades of experience commissioning GxP compliant IT infrastructures for CROs, Biotech, and Pharma organisations. The intended audience comprises industry professionals tasked with maintaining GxP compliance through the use of secure and validated IT systems in Biotech labs or Manufacturing facilities. While avoiding a lecture on GxP basics, it's beneficial to provide some key definitions for those less familiar with the topic.

In heavily regulated sectors like pharmaceuticals, biotechnology, medical devices, and healthcare, adherence to GxP (Good Practice) guidelines is paramount for ensuring product quality, safety, and regulatory compliance. GxP includes GMP (Good Manufacturing Practice), GLP (Good Laboratory Practice), and GCP (Good Clinical Practice), each tightly linked to specific aspects of lab testing, pharma manufacturing, or clinical research. Attaining and upholding GxP compliance is a challenging task, demanding ongoing scrutiny and evaluation across multiple fronts.

For companies operating in these sectors, maintaining GxP compliance isn't merely a regulatory checkbox; it's essential for ensuring quality and safety across all stages of clinical testing, development, or manufacturing. A well-implemented and tightly secured IT infrastructure, processes, and controls are indispensable for achieving GxP compliance. Engaging an IT company with subject matter expertise such as Exigence is crucial for navigating the complex landscape of GxP compliance successfully.

Understanding Regulatory Requirements

Similar to hiring an architect familiar with local building codes to design a house, your IT services provider must grasp the specific GxP regulations applicable to your project. These requirements vary based on location and target regulatory authority, such as TGA for Australia, FDA for North America, and EMA for Europe. While overlaps occur, FDA and EMA tend to have stricter requirements compared to Australian counterparts.

Choosing the Right IT Partner

Implementing GxP compliant systems and processes isn't cheap or quick. Providers unfamiliar with your industry lack the expertise to implement systems with the necessary controls for successful validation and compliance. Experience matters. Your chosen provider should have a proven track record of implementing IT solutions compliant with GLP, GMP, or GCP, as achieving this level of compliance presents unique challenges. Failure to execute this process correctly will result in the inability to meet the necessary compliance standards, necessitating either partial or complete redesigns, additional qualification, and validation efforts, thereby increasing costs.

Security, Reliability, and Audit Trails

Your IT partner's primary responsibility is to implement IT infrastructure supporting GxP compliance. Systems like EDMS (Electronic Document Management System), QMS (Quality Management System), LIMS (Laboratory Information Management System), and validated SaaS (Software-as-a-Service) solutions must align with GxP principles and specific regulatory requirements, prioritising attributes like security, reliability, and audit trail/tracking. Your partner should design and implement a cybersecurity strategy using cutting-edge technologies such as MDR (Managed Detection and Response), EDR (Endpoint Detection and Response), XDR (Extended Detection and Response), and IAM (Identity and Access Management).

Validation and Qualification

Validating IT systems used in regulated environments is fundamental to ensuring their suitability for intended use. Your IT partner assists with validating all hardware and software components, covering IQ (Installation Qualification), OQ (Operational Qualification), and PQ (Performance Qualification) in collaboration with system vendors and stakeholders, recording all validation activities for audit review and trail.

Periodic Reviews, Maintenance, and Support

Your managed IT services company should cover all GxP regulated systems under their managed services plan, conducting regular audits to ensure ongoing compliance. A robust helpdesk and support system, in collaboration with system vendors, is critical for smooth operations, with IT support engineers well-versed in GxP requirements and adhering to strict change management procedures to maintain compliance. To ensure ongoing compliance and identify any gaps, all gaps need to be clearly documented and remedied using corrective action plan.

Your IT services provider, in collaboration with system vendors, bears the responsibility of delivering support and maintenance for all validated systems and beyond. It's imperative that IT support engineers comprehend the GxP requirements thoroughly, ensuring that any modifications undergo a strict change management process to prevent any system from falling out of the validated state. From a cybersecurity standpoint, frameworks such as the Essential Eight guarantees that your validated infrastructure is fortified against known threats and resilient in the face of potential threat actors.

Contact Exigence to discuss how our specialist services can help your organisation

Selecting an experienced IT services company is crucial for designing and implementing IT systems within GxP regulated environments. Engaging a partner with a proven track record is essential for achieving and maintaining GxP compliance.

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