Why Audit?

Temperature-controlled environments aren’t static. Over time, small changes — from ageing equipment to increased load, new processes or staffing changes — can add up to meaningful risk. In regulated industries, that can mean compliance drift, system underperformance, or unrecognised vulnerabilities.

An audit helps you step back and ask:

• Is the system still fit for purpose?
• Are we meeting all relevant compliance requirements?
• Are our alarm and monitoring systems truly reliable?
• Is the risk of failure, deviation or downtime fully understood?
• Could we be operating more efficiently or safely?

Whether you're preparing for an MHRA or FDA inspection, reviewing SOPs, or taking over a facility with limited documentation, our audits provide a clear, structured view of your current state — and what needs to happen next.

What We Review

Our audits are tailored to your environment, but typically include a comprehensive

review of:

• Refrigeration and HVAC system performance
• Temperature control and distribution (including airflow, loading, and stratification)
• Sensor placement, calibration and alarm functions
• Compliance with GMP, GDP, MHRA, and other applicable standards
• Monitoring and data logging systems
• Maintenance records and servicing history
• Emergency protocols and failover capacity
• System documentation and validation readiness
• SOP alignment with actual technical performance

We combine physical inspection, technical data analysis, and a review of operational

practices to give you a full picture — both from an engineering and regulatory

perspective.

Clear Reports. Actionable Insights.

Our audit reports are designed to be useful — not just lengthy. We highlight what’s working, what isn’t, and what needs to be addressed, clearly prioritised and backed with technical explanation.

Every audit includes:

• A summary of current performance and risks
• A compliance alignment overview
• A set of clearly defined, actionable recommendations
• A roadmap for upgrades, improvements or requalification (where needed)
• Supporting photos, diagrams, and technical observations
• A debrief meeting with your team (on-site or virtual)

We can also support any next steps — from project planning and system redesign to temperature mapping, validation and regulatory inspection support.

When Is the Right Time for an Audit?

Facility audits are useful at many stages in your operation’s life cycle, including:

• Before a regulatory inspection (MHRA, FDA, ISO, etc.)
• After an audit with findings or corrective actions
• During acquisition, site expansion or repurposing
• Following a temperature excursion or system failure
• When validation is due but documentation is incomplete
• As part of a wider risk and resilience review
• To prepare for a capital investment or refurbishment

Even well-run sites benefit from external, expert perspective. Our goal is to strengthen your operations and give you the confidence that your systems are where they need to be — or a clear plan to get them there.

We Understand Regulated Environments

Our team doesn’t just tick boxes — we work in the very industries we audit. From

GMP pharmaceutical storage and cleanrooms to blood fridges, vaccine freezers, and

biotech labs, we bring hands-on engineering knowledge and real-world compliance

experience.

We’re fluent in the language of:

• EU GMP and GDP
• MHRA and FDA guidance
• WHO technical reports
• ISO 15189, 17025, 14644 and cleanroom classifications
• HTA, NHS standards, and SOP best practices

We also understand that no two facilities are the same — and we tailor our approach

to suit your size, structure, risk profile and resource availability.

Across the UK and Western Europe

We carry out audits for clients across the UK and throughout Western Europe, working with single-site facilities and multi-site operations. Whether you need a deep-dive inspection of a single chamber or a coordinated audit of multiple cold rooms, we’re ready to help.