Bridging the GxP Gap
Between Quality and IT

Do you measure it? Does it need a boost — or are you simply lacking one? Then we might be the people for you.

EmpowermentQE have worked across dozens of Quality Systems and know that the effectiveness of a QMS can make or break a project.

Our GxP IT auditing service has exposed us to the Quality Systems of major global IT Suppliers. We've seen what works — and a lot that doesn't.

Our approach is grounded in real engineering experience. We focus on efficient process and defect prevention throughout the entire QMS, ensuring quality drives productivity rather than impeding it.

Do you want a certificate of documentation compliance — or do you really want to know the quality of your system? There is a difference, and we know exactly how to find it.

Our background as software and network engineers means we cut through technical jargon, quickly spot gaps, identify root cause, and establish effective mitigations.

Our audit offering is the result of hundreds of audits conducted globally:

• Internal Compliance Audits
• Computerised System/Tool Selection & Assessment
• Supplier Audits: Bespoke software, Cloud (PaaS, IaaS, SaaS)
• Themed Audits: Security, Testing, Risk Management, Change Control, Metrics
• GDPR Sub-Processor Assessments
• Audit Preparation for Suppliers
• AI/ML System Audits: Assessment of AI/ML-driven systems against regulatory requirements, technical practices and the EU AI Act risk classification framework.

Robust requirements are essential for integrity, quality, and end patient health. Our approach is preventative by design:

• Preventative Approach: Prevent mistakes, conflicts and gaps in requirements that lead to defects in production.
• Critical Thinking: Challenge your business, regulatory and technical needs at every stage.
• Bespoke Approach: Use risk assessment to define a project-specific path that fits your unique context.
• Inclusive Approach: Facilitate system workshops and create clear, unambiguous requirement documents.
• Collaborative: Communicate requirements to all stakeholders and suppliers for review and buy-in.

Ineffective testing leads to delayed releases, increased costs, disgruntled users, and patient health risks. We've learnt how to apply robust verification that challenges every weakness across the entire life-cycle. Learn how to:

• Devise a strategy to prevent and then detect issues earlier, when it is cheaper and safer to correct them.
• Capture the appropriate level of evidence of each verification activity to support process effectiveness measurement.
• Use Risk to justify and define the entire scope of verification — including supplier activities.
• Leverage Defect Removal Efficiency to demonstrate strategy effectiveness and predict latent production issues.
• Confidently apply the Computer Software Assurance approach.
• Apply AI/ML Model Validation techniques aligned to the various regulatory guidance — covering items such as algorithm performance, bias assessment, and drift monitoring.

Our training challenges delegates on how they view their role, who their internal customers are, and how their actions impact business value and patient health. Topics include:

• Quality Management & Risk-Based Quality Approach
• GxP Regulations for Developers
• Software Development Life-cycle Processes (Configuration Management, Change Control)
• Testing (Processes, Techniques, Roles, Phases, Tools)
• Computerised System Validation
• Effective Team Management
• AI/ML Governance for GxP — Demystify all things AI, EU AI Act obligations, regulatory guidance, ISO 42001 and technical implementations, delivered by Oxford Saïd-trained practitioners.

Our consultants continuously work in the field, bringing relevant, real-life examples that genuinely empower your people.

We understand the complex relationships between every decision, role and activity in the software life-cycle. It is the aggregation of marginal gains that provides real value. We can help with:

• Process Improvement: Tailor proven Software and IT engineering processes to your current needs.
• Effective Metric Analysis: Use metrics to baseline process, prioritise improvements and demonstrate quality.
• GDPR Assessments: Document sub-processor activities, identify gaps, and define mitigations.
• Risk Management: Everyone talks about it — we actually do it. Practical, evidence-based risk programmes.
• Building Security In: 75% of defects occur at the software level (Gartner). We help you refocus from the outset.
• Bespoke Training: Delivered across IT, Software and Validation processes, globally.
• Supplier Selection: Evaluate, score and select the right technology partner using a structured, risk-based assessment framework aligned to your regulatory and business requirements.
• AI/ML Compliance Support: Classify AI systems by risk tier, identify obligations under the EU AI Act and the various regulatory bodies, and harden implementation and validation approachs to define a compliant implementation roadmap.