GxP Engineering Consultancy And Validation Services

Accelerating GxP clients towards their engineering compliance goals. Providing leading expertise in technology systems, which improve productivity, product quality and patient safety. Coming Soon : CPD Approved Medical Device Software Validation Training Course, in line with GAMP 5. Products for Sale : New Document Templates are now Available for Purchase.

GxP Engineering Consultancy And Validation Services

Zener Engineering Services Ltd Logo

GxP Engineering
Consultancy And
Validation Services

Quality Systems

GxP Quality Systems
Zener Engineering Services Ltd

GxP Quality Systems
Zener Engineering Services Ltd

GxP Quality Systems
Zener Engineering Services Ltd

Need GxP Quality Management System Improvement?

Zener Engineering Services Ltd (ZES) can implement, improve and monitor GxP Quality Management Systems (QMS) required for the whole of your GxP operation. Whatever your business sector or size, QMS are an essential FDA, MHRA and EMA regulatory requirement. ZES can provide systems which work with your business, rather than against, to ensure value adding is achieved. ZES can help your business achieve ISO9001:2015.

Quality Systems ZES can implement include:

  • Permit to Work
  • Change Control
  • Electrical Isolation
  • Risk Assessments
  • Documentation Control
  • Risk-Based Maintenance
  • Validation
  • Labelling and Packaging Controls
  • Data & Record Integrity & Security
  • Training & Qualification Verification
  • Standard Operating Procedures (SOPs)
  • Corrective Action / Preventative Action (CAPA)
Let's Talk

Need GxP Quality Management System Improvement?

Zener Engineering Services Ltd (ZES) can implement, improve and monitor GxP Quality Management Systems (QMS) required for the whole of your GxP operation. Whatever your business sector or size, QMS are an essential FDA, MHRA and EMA regulatory requirement. ZES can provide systems which work with your business, rather than against, to ensure value adding is achieved. ZES can help your business achieve ISO9001:2015.

Quality Systems ZES can implement include:

  • Permit to Work
  • Change Control
  • Electrical Isolation
  • Risk Assessments
  • Documentation Control
  • Risk-Based Maintenance
  • Validation
  • Labelling and Packaging Controls
  • Data & Record Integrity & Security
  • Training & Qualification Verification
  • Standard Operating Procedures (SOPs)
  • Corrective Action / Preventative Action (CAPA)
Let's Talk

Need GxP Quality Management System Improvement?

Zener Engineering Services Ltd (ZES) can implement, improve and monitor GxP Quality Management Systems (QMS) required for the whole of your GxP operation. Whatever your business sector or size, QMS are an essential FDA, MHRA and EMA regulatory requirement. ZES can provide systems which work with your business, rather than against, to ensure value adding is achieved. ZES can help your business achieve ISO9001:2015.

Quality Systems ZES can implement include:

  • Permit to Work
  • Change Control
  • Risk Assessments
  • Electrical Isolation
  • Documentation Control
  • Risk-Based Maintenance

 

  • Validation
  • Labelling and Packaging Controls
  • Training & Qualification Verification
  • Data & Record Integrity & Security
  • Standard Operating Procedures (SOPs)
  • Corrective Action / Preventative Action (CAPA)

 

Best Quality Provided By Zener Engineering Services Ltd
Pharmaceutical Products Validated By Zener Engineering Services Validation Consultants
Quality Systems Templates From Zener Engineering Services Ltd
Doctor Administering A Pharma Injection Validated By Zener Engineering Services
Validation Consultancy By An Experienced CSV Consultant To Gamp 5 To Ensure Data Integrity
Pharmaceutical Products Validated By Zener Engineering Services Validation Consultants
Quality Systems Templates From Zener Engineering Services Ltd
Doctor Administering A Pharma Injection Validated By Zener Engineering Services
Validation Consultancy By An Experienced CSV Consultant To Gamp 5 To Ensure Data Integrity
Pharmaceutical Products Validated By Zener Engineering Services Validation Consultants
Quality Systems Templates From Zener Engineering Services Ltd
Doctor Administering A Pharma Injection Validated By Zener Engineering Services
Validation Consultancy By An Experienced CSV Consultant To Gamp 5 To Ensure Data Integrity
NHS Logo

Don’t just take our word for it...

NHS EBME Department Review:
Improvements Implemented

"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.


Head of Clinical Engineering
Band 8B

EBME Case Study
Aesica Logo

Don’t just take our word for it...

Pharma Manufacturing: Full Site Validation

"I briefly worked with David of Zener Engineering Services, when he was engaged as a validation manager.

David is an accomplished validation engineer and works to a high standard expected within the regulated environment.

I would have no hesitation in recommending him to anyone seeking a highly experienced engineering professional who knows his subject matter very well."


Bashir Hansraj - Technical Director
Aesica Pharmaceuticals Ltd

Aesica Logo

Don’t just take our word for it...

Pharma Manufacturing: Full Site Validation

"I briefly worked with David of Zener Engineering Services, when he was engaged as a validation manager.

David is an accomplished validation engineer and works to a high standard expected within the regulated environment.

I would have no hesitation in recommending him to anyone seeking a highly experienced engineering professional who knows his subject matter very well."


Bashir Hansraj - Technical Director
Aesica Pharmaceuticals Ltd

Satisfaction Logo

Don’t just take our word for it...

Medical Device FDA 510(k) Clearance:

"Your consultancy was invaluable to us and we appreciate the time and advice you provided. We are currently analysing the information discussed to decide our next course of action...."


Regulatory Affairs Officer
Confidential UK Manufacturer

BD Logo

Don’t just take our word for it...

Sterile Medical Device Manufacturing Facility:

"The project was the installation of a Class III, Sterile Medical Device manufacturing line.
(56m Euro)

During the course of the project, ZES showed considerable knowledge on a wide variety of engineering functions and were a key member in the design process of the facility and manufacturing equipment.

...... ZES showed considerable knowledge on engineering and validation."

QC/RA Specialist
BD Medical

Quality Management
System Improvement
By ZES

Contact ZES for all your
Quality Management System needs

Contact Options

Quality Management
System Improvement
By ZES

Contact ZES for all your
Quality Management System needs

Contact Options

Quality Management System Improvement
By ZES

Contact ZES for all your Quality Management System needs
Contact Options
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