GxP Design Solutions By ZES

Building Compliance From The Ground Up

In highly regulated industries like Pharmaceuticals, Biotechnology, Life Sciences and Healthcare, design isn’t just about aesthetics or efficiency — it’s about compliance. For organisations operating under GxP (Good Practice) frameworks like GMP, GLP, GCP, GDP, and GEP, even small missteps in facility layout, process design, or automation can lead to critical compliance risks. This is where Zener Engineering Services Ltd (ZES) bring real value: their GxP Design Solutions build regulatory rigour right into the heart of the Engineering and IT process.

What Does GxP Design Mean To ZES?

At ZES, GxP design is not simply about putting pen to CAD paper. Instead, it’s a compliance-driven, engineering-led philosophy. Every ZES design decision is aligned with the expectations of Good Practice, ensuring that regulatory standards - whether GMP, GEP, GDP, GLP, or GCP - are integrated from day one of any project.

This means that from the very first solution concept, ZES consider not only the technical and operational demands of a GxP facility, system or manufacturing equipment, but also how those demands shall best meet and satisfy regulatory compliance requirements.

The ZES ultimate goal is always to provide a solution for regulated facilities and processes that are safe, robust and inspection-ready, without sacrificing performance.

Core Capabilities: Zener’s GxP Design Expertise

ZES primarily offer a comprehensive design service tailored for Clients who operate in Life Sciences. The ZES GxP design solutions capability include, but are not limited to, the following services:

GMP Facility & Layout Design

ZES can support the design of production suites with meticulous planning of material and personnel flows. ZES design cleanrooms to comply with ISO 14644 and EU GMP classifications, and can include containment areas for potent compounds.

Utilities are a key part of any Cleanroom design: ZES can design HVAC systems and water systems such as PW (purified water), UPW (ultra-purified water), and WFI (water for injection), as well as clean steam, gases, and other Life-Science critical utilities.

Process & Equipment Design

ZES can assist with User Requirement Specifications (URS), Functional Design Specifications (FDS), and Detailed Design Specifications (DDS) for any Life Science manufacturing process.

ZES can also undertake process mapping and optimisation, aligning operations with regulatory requirements. Crucially, ZES have guided Life Science Clients to make appropriate equipment selection and integration, ensuring that automation systems comply with Data Integrity regulatory requirements such as 21 CFR Part 11 and Annex 11.

ZES have listed a number of case studies on their website, where Clients have selected the wrong equipment or Supplier to the Clients' detriment.

Qualification & Validation (CQV)

ZES can support Design Qualification (DQ) from the early phases of a project and carry out risk-based assessments (using tools like FMEA), following GEP or GAMP 5 principles. The ZES commissioning and qualification strategies are designed with inspection readiness in mind, backed by detailed validation documentation.

Regulatory & Quality Compliance

A major strength, in the Design Solutions provided by ZES, lie in ZES Consultants' deep understanding of regulatory frameworks and requirements. ZES Consultants will factor in requirements from EU GMP, FDA, ICH, and MHRA, among others. ZES embed Data Integrity practices (such as ALCOA +) and Good Engineering Practice across all design phases.

For existing facilities, ZES can also conduct gap analyses and propose suitable GxP remedies, while also integrating Quality-by-Design (QbD) principles to future-proof GxP manufacturing operations.

Why ZES Is the Right Partner for GxP Design

ZES don’t just design for function — ZES design for compliance, inspection-readiness, and long-term operational strength. Why do Life Science Clients trust ZES?:

• Qualified Expertise: The ZES team consists of Chartered Engineers with deep experience of manufacturing operations in the Life Science industry
• Tailored Solutions: ZES provide bespoke design solutions. ZES work closely with Clients to understand their unique operational, regulatory, and commercial needs, to produce a suitable regulatory compliant solution
• Inspection Readiness: ZES build in Life Science regulatory compliance from the beginning of a project, enabling Clients to reduce risk, accelerate qualification, and support smooth regulatory inspections
• Flexible Engagement: Whether it’s early-concept planning or full detailed design and validation delivery, ZES offer flexible support and can scale to the project size as required
• Robust Documentation: Technical accuracy and high-quality documentation are standard deliverables from ZES, which are critical for future audits, inspections, or future expansions

Industries That Benefit From Zener’s GxP Design Solutions

ZES’s design services are versatile and suit a wide range of regulated industries. Some of the sectors ZES primarily support include:

• Pharmaceuticals: Manufacturing plants, sterile production suites, containment systems
• Biotechnology & Advanced Therapies: Cell and gene therapy manufacturing, ATMPs
• Medical Devices: Design of Cleanrooms, device production, special utilities
• Healthcare & Diagnostics: Hospital labs, Theatres, EBME (Estates, Buildings & Medical Engineering)
• Food, Nutraceutical, and High-Tech Manufacturing: Areas where quality and regulatory compliance are critical 

Putting It All Together: A Compliance-First Approach

What sets Zener Engineering Services Ltd apart is how they blend Quality Engineering and IT excellence with regulatory compliance. The ZES design process doesn't have a separate compliance checkbox, it has a compliance culture at its core. By embedding GxP best practice into every stage — from initial layout to process specification, from risk assessment to qualification — ZES ensure that the final system is not just operable, but validated to a suitable required standard and resilient.

This approach helps Life Science organisations to:

• Lower risk by identifying compliance issues early
• Save time and cost by avoiding regulatory rework
• Build systems that are inspection-ready and scalable
• Focus on patient safety, product quality, and long-term regulatory alignment

Real-World Impact: Trusted by Regulated Clients

ZES’s track record speaks volumes. ZES Clients include Pharmaceutical, Medical Device manufacturers, and Healthcare providers who rely on the ZES compliance-first methodology. On the ZES website (www.zeneronline.co.uk) , testimonials are quoted that emphasise the ZES technical expertise, regulatory insight, and collaborative approach.

For example, Clients have praised ZES for their deep knowledge and understanding across Life Sciences, and for providing tailored support regardless of project complexity.

Final Thoughts: Why GxP Design Matters — And Why ZES Deliver

In a highly regulated industry, a design misalignment can become a significant regulatory risk which is profoundly understood by Zener Engineering Services Ltd. Their GxP Design Solutions are about more than building walls, piping, or automating processes — they’re about building trust with regulatory bodies, securing patient safety, and delivering operations that work and comply today and will scale and comply tomorrow.

By awarding projects to ZES, Clients are not just buying a design service — they’re partnering with a GxP-dedicated company that truly understands the close relationship of Engineering, IT, Quality, and GxP Regulations. With a compliance-driven design philosophy, ZES help transform ideas into validated, inspection-ready, and high-performing systems for current manufacturing needs.

If your organisation is planning a facility build, upgrade, automation or IT project, and compliance is non-negotiable, it’s well worth booking a free consultation with ZES to discuss your GxP design requirements.