GxP Compliant Design Solutions For Life Sciences
GxP Compliant Design Solutions For Life Sciences
GxP Compliant Design Solutions For Life Sciences
GxP Design Solutions Intro
Zener Engineering Services Ltd provide specialist GxP-compliant design solutions that support safe, reliable, and efficient operations in regulated industries.
Our engineering-led approach ensures that every design decision aligns with Good Practice (GxP) expectations, including GMP, GEP, GLP, and GDP requirements.
ZES deliver clarity, technical precision, and practical solutions that help Life Science Clients meet regulatory standards without compromising operational performance.
Delivering Compliance-Focused Engineering
GxP design is more than producing drawings—it is the integration of quality, regulatory understanding, and engineering excellence. The ZES team ensures that compliance is built into your facility, process, or system from the outset, reducing risks and supporting long-term operational integrity.
The ZES design approach integrates GxP considerations from the very beginning, resulting in facilities and systems that are
compliant, efficient, and future-proof.
GxP Design Solutions Intro
Zener Engineering Services Ltd provide specialist GxP-compliant design solutions that support safe, reliable, and efficient operations in regulated industries.
Our engineering-led approach ensures that every design decision aligns with Good Practice (GxP) expectations, including GMP, GEP, GLP, and GDP requirements.
ZES deliver clarity, technical precision, and practical solutions that help Life Science Clients meet regulatory standards without compromising operational performance.
Delivering Compliance-Focused Engineering
GxP design is more than producing drawings—it is the integration of quality, regulatory understanding, and engineering excellence. The ZES team ensures that compliance is built into your facility, process, or system from the outset, reducing risks and supporting long-term operational integrity.
The ZES design approach integrates GxP considerations from the very beginning, resulting in facilities and systems that are
compliant, efficient, and future-proof.
GxP Design Solutions Intro
Zener Engineering Services Ltd provide specialist GxP-compliant design solutions that support safe, reliable, and efficient operations in regulated industries.
Our engineering-led approach ensures that every design decision aligns with Good Practice (GxP) expectations, including GMP, GEP, GLP, and GDP requirements.
ZES deliver clarity, technical precision, and practical solutions that help Life Science Clients meet regulatory standards without compromising operational performance.
Delivering Compliance-Focused Engineering
GxP design is more than producing drawings—it is the integration of quality, regulatory understanding, and engineering excellence. The ZES team ensures that compliance is built into your facility, process, or system from the outset, reducing risks and supporting long-term operational integrity.
The ZES design approach integrates GxP considerations from the very beginning, resulting in facilities and systems that are
compliant, efficient, and future-proof.
"ZES are superb in delivering a great service."
Peter West
Head of Quality Affairs at ECLEVAR
"ZES are superb in delivering a great service."
Peter West
Head of Quality Affairs at ECLEVAR
GxP Design Capabilities
ZES offers comprehensive GxP-compliant design services that support the development, modernisation, and validation of regulated environments across the pharmaceutical, biotechnology, and Life Science sectors. The ZES approach integrates regulatory expertise, engineering excellence, and quality-driven project execution to ensure that facilities, systems, and processes fully align with global GxP standards, including Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), and Good Clinical Practice (GCP).
At ZES, we combine deep domain knowledge with practical implementation experience to deliver designs that are audit-ready, sustainable, scalable, and aligned with Client operational goals.From early conceptual planning to detailed engineering and qualification support, our multidisciplinary team ensures that every design decision supports product quality, patient safety, and regulatory compliance.
The ZES GxP Design Capabilities include but are not limited to:
GMP Facility & Layout Design
- Production suite planning and material/personnel flow design
- Cleanrooms (ISO 14644 / EU GMP classifications)
- Containment areas for potent compounds
- Specialist utilities: HVAC (with full DQ), PW/UPW systems, clean steam, gases
Process & Equipment Design
- URS, FDS, DDS preparation
- Process mapping and optimisation for regulatory alignment
- Equipment selection and integration
- Automation and data integrity compliance (21 CFR Part 11 / Annex 11)
Qualification & Validation (CQV) Support
- Design Qualification (DQ)
- Risk assessments (FMEA, GEP, GAMP 5-based approaches)
- Commissioning & Qualification strategies
- Validation documentation and support for inspections
Regulatory & Quality Compliance
- EU GMP, FDA, ICH, MHRA requirements
- Data integrity implementation (ALCOA+)
- GEP-based engineering practice throughout all design phases
- Gap analysis and remediation planning for existing facilities
- Quality-by-Design (QbD) Integration
Through their GxP design services, ZES help Clients bring facilities and systems online efficiently—reducing project risk, accelerating compliance milestones, and building strong foundations for future operational excellence. All activities are supported by the highest levels of documentation.
ZES can act on behalf of a NHS trust or End Client on a project, to ensure the supplier meets the required standard and delivers on their promises.
Contact ZES for all your engineering compliance needs.
GxP Design Capabilities
ZES offers comprehensive GxP-compliant design services that support the development, modernisation, and validation of regulated environments across the pharmaceutical, biotechnology, and Life Science sectors. The ZES approach integrates regulatory expertise, engineering excellence, and quality-driven project execution to ensure that facilities, systems, and processes fully align with global GxP standards, including Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), and Good Clinical Practice (GCP).
At ZES, we combine deep domain knowledge with practical implementation experience to deliver designs that are audit-ready, sustainable, scalable, and aligned with Client operational goals.From early conceptual planning to detailed engineering and qualification support, our multidisciplinary team ensures that every design decision supports product quality, patient safety, and regulatory compliance.
The ZES GxP Design Capabilities include but are not limited to:
GMP Facility & Layout Design
- Production suite planning and material/personnel flow design
- Cleanrooms (ISO 14644 / EU GMP classifications)
- Containment areas for potent compounds
- Specialist utilities: HVAC (with full DQ), PW/UPW systems, clean steam, gases
Process & Equipment Design
- URS, FDS, DDS preparation
- Process mapping and optimisation for regulatory alignment
- Equipment selection and integration
- Automation and data integrity compliance (21 CFR Part 11 / Annex 11)
Qualification & Validation (CQV) Support
- Design Qualification (DQ)
- Risk assessments (FMEA, GEP, GAMP 5-based approaches)
- Commissioning & Qualification strategies
- Validation documentation and support for inspections
Regulatory & Quality Compliance
- EU GMP, FDA, ICH, MHRA requirements
- Data integrity implementation (ALCOA+)
- GEP-based engineering practice throughout all design phases
- Gap analysis and remediation planning for existing facilities
- Quality-by-Design (QbD) Integration
Through their GxP design services, ZES help Clients to bring facilities and systems online efficiently—reducing project risks, accelerating compliance milestones, and building strong foundations for future operational excellence. All activities are supported by the highest levels of documentation.
ZES can act on behalf of a NHS trust or End Client on a project, to ensure the supplier meets the required standard and delivers on their promises.
Contact ZES for all your engineering compliance needs.
Industries ZES Support
Design Solutions provided ZES by can cover a number of high regulated industries, including but not limited to:
- Pharmaceuticals
- Biotechnology
- Advanced Therapies (ATMPs, Cell & Gene)
- Medical Devices
- Healthcare & Diagnostics
- Food, Nutraceutical, and High-tech Manufacturing
To discuss your project or learn how we can support your GxP design requirements, contact the ZES team. ZES are here to help you build safe, compliant, and reliable operations with confidence.
Why Choose Zener Engineering Services Ltd?
The ZES focus is always on delivering compliant, efficient, and inspection ready solutions that enhance operational performance. Therefore ZES provide:
- Trusted expertise in regulated-industry engineering
- Clear, practical guidance at every stage of design
- Designs aligned with global regulatory expectations
- Technical accuracy and robust documentation as standard
- Flexible engagement—from concept development to full project delivery
See ZES Client Testimonials below:
Why not give ZES a call to discuss your GxP Design requirements?
Industries ZES Support
Design Solutions provided ZES by can cover a number of high regulated industries, including but not limited to:
- Pharmaceuticals
- Biotechnology
- Advanced Therapies (ATMPs, Cell & Gene)
- Medical Devices
- Healthcare & Diagnostics
- Food, Nutraceutical, and High-tech Manufacturing
To discuss your project or learn how we can support your GxP design requirements, contact the ZES team. ZES are here to help you build safe, compliant, and reliable operations with confidence.
Why Choose Zener Engineering Services Ltd?
The ZES focus is always on delivering compliant, efficient, and inspection ready solutions that enhance operational performance. Therefore ZES provide:
- Trusted expertise in regulated-industry engineering
- Clear, practical guidance at every stage of design
- Designs aligned with global regulatory expectations
- Technical accuracy and robust documentation as standard
- Flexible engagement—from concept development to full project delivery
See ZES Client Testimonials below:
Why not give ZES a call to discuss your GxP Design requirements?
Testimonials From Various Satisfied Clients
SSD LIMITED
Don’t just take our word for it...
AE Services: Theatre Sterile Supply Unit
"Interacting with Zener Engineering Services was a education. Its a scarce event that we get to meet those willing to share their knowledge - Its even rarer to encounter an organisation with such a wide range of experience on tap."
(Google Review *****)
Garth Rowbottom
Director
Sterile Service Developments Ltd
Don’t just take our word for it...
Authorising Engineer: Ventilation and Mechanical
"David [of Zener Engineering Services Ltd] is incredibly knowledgeable across several specialist fields, such as clinical and pharmaceutical, as such is able to provide tailored support to various projects regardless of the complexities involved.
In addition David has fantastic interpersonal skills which make him a really easy co-worker."
Robert Cantillon
Head of Property and Facilities Management
Practice Plus Group
Don’t just take our word for it...
EBME Department Improvements: Audit Report Findings
"I am writing to provide an excellent professional reference for Zener Engineering Services, who were brought in to review the EBME department and make suggestions for improvement, with regards to ways of working, quality systems, personnel structure, staff bandings and management issues.
Due to the excellent quality of the audit report submitted ............ the documented improvements were sufficiently valued to warrant implementation."
Terry Smith
Head of Clinical Engineering
University Hospital Southampton
GxP Compliant Design Solutions For Life Sciences
Qualified Expertise: Chartered engineers with extensive experience in Life Sciences.
Tailored Solutions: Services customised to meet the unique needs of your facility.
Let’s Ensure Your Facility Runs Safely and Efficiently
Partner with ZES for reliable,
professional Design Solutions that prioritise patient safety and compliance.
Get in touch today to discuss your requirements and schedule a consultation.
GxP Compliant Design Solutions For Life Sciences
Qualified Expertise: Chartered engineers with extensive experience in Life Sciences.
Tailored Solutions: Services customised to meet the unique needs of your facility.
Let’s Ensure Your Facility Runs Safely and Efficiently
Partner with ZES for reliable,
professional Design Solutions that prioritise patient safety and compliance.
Get in touch today to discuss your requirements and schedule a consultation.
GxP Compliant Design Solutions For Life Sciences
Qualified Expertise: Chartered engineers with extensive experience in Life Sciences.
Tailored Solutions: Services customised to meet the unique needs of your facility.
Let’s Ensure Your Facility Runs Safely and Efficiently
Partner with ZES for reliable,
professional GxP Design Solutions that prioritise patient safety and compliance.
Get in touch today to discuss your requirements and schedule a consultation.
