April 2023
LinkedIn Followers
During April 2023, Zener Engineering Services Ltd (ZES) are thrilled to announce that ZES have reached 1500+ followers on LinkedIn!
ZES are grateful for the support and engagement from our LinkedIn followers, and we are proud to have such a strong and growing network of professionals who share our passion for innovation and excellence in GxP Engineering and Validation.
As a company, ZES are committed to providing excellent quality products and services, and we are always looking for new ways to enhance our offerings and better serve our Life Science customers.
We believe that LinkedIn is a valuable platform for connecting with our customers, partners, and other industry leaders, and we are excited to continue sharing our insights, news, and updates with our followers.
Thank you to the 1500+ for your continued support, and ZES look forward to connecting with new followers on LinkedIn and beyond.
ZES Director David Easton commented:
‘We expect the number of followers to keep growing on account of our excellent GxP quality engineering services, whilst delivering compliance and customer value. Our high level of proven GxP experience and added value for our clients were key factors in recent contract wins.'
Don't follow ZES on LinkedIn? Click below to follow.
Feb 2021
Managing Medical Devices Update
The MHRA document purpose is to outline a systematic approach to the acquisition, deployment, maintenance (preventive maintenance and performance assurance), repair and disposal of medical devices and medical device training.
The document is intended primarily for people in hospital and community based organisations that are responsible for the management of reusable medical devices, to help them set up and develop systems that promote the use of the medical devices for safe and effective health care. This document replaces the following:
- DB 2006(05) Managing Medical Devices. Guidance for healthcare and social services organisations, November 2006
- DB 2005(03) Guidance on the safe and effective use of batteries and chargers for medical devices, October 2005.
Download the latest Version 1.3 below:
Dec 2020
World Health Organization
In response to the recent urgent need for the fast development of health products in the treatment of COVID-19, the World Health Organization (WHO) are in the process of developing a Good Manufacturing Practice (GMP) document to address the manufacturing of developmental batches, pilot batches and the sequential stability data that is submitted in product applications (dossiers) for marketing authorization and the prequalification of medical products.
There are currently no regulatory guidelines which address this matter, although the data collected from these batches influences the following aspects of the product:
- Stability
- Process validation
- Analytical method development and validation
Download a Copy of the Draft Document Below:
Nov 2020
ZES Director Steps Down From The RCT After Over 6 Years
The Register of Clinical Technologists (the RCT) – formerly the Voluntary Register of Clinical Technologists – was formed in 2000 with the aim of protecting the public by advocating statutory, professional regulation for Clinical Technologists. The register now holds the details of over 2000 healthcare professionals who have achieved the standards set out by the RCT through education or equivalence. They abide by a regularly-reviewed Code of Professional Conduct and take part in continuing professional development (CPD) to maintain their professional status for the protection of the public at all times.
The Management Board are responsible for all aspects of the management of the register including overseeing the assessing and approving of applications to join the RCT. They are also responsible for reviewing and updating the criteria for membership of the RCT as well as all processes and documentation used. The RCT Management Board are supported by an administrative team from the Institute of Physics and Engineering in Medicine (IPEM) office.
The RCT Management Board actively promote the RCT to government, the Department of Health, government agencies, the Health and Care Professions Council, other professional bodies, educational establishments and the medical device industry.
Iain Threlkeld, Registrar explains
'Dave and I joined the RCT management panel, as it was then called, back in 2013 when IHEEM replaced the IET as the third professional body administering the RCT, and is therefore one of the longest serving of our current members.
I would like to thank Dave on behalf of everyone on the RCT management board for all his help and support over the years and would like to wish him all the best for his future.'
David adds
'I've been the IHEEM representative on the RCT management board for over 6 years and in that time I've contributed enthusiastically to the register's activities in a small but essential way, primarily being the improvement of safety standards for patients, by helping to ensure and raising the standards within the Medical Device maintenance activity, carried out in hospitals.
I would like to thank the other members of the Management Board, both previous and current, for their contribution and their professionalism throughout my tenure. I would like to sincerely wish the RCT every success in the future.'
Read the good wishes David received from the RCT published in the ZES BLOG
Download the members of the RCT Management Board just before David stepped down below.
April 2020
ZES Asked To Help Validate A Vaccine Manufacturing Facility
ZES are proud to have been asked to validate a new vaccine manufacturing process and facility, for clinical trials.
"I'm proud to head up a company with a reputation for quality and compliance engineering excellence. The ZES office manager Faye Travis is on the front line treating patients, and our engineers are ready to help against the CORONAVIRUS, with a vaccine manufacturing operation, validated to our usual high standards."
David Easton MSc CEng FIHEEM MIET
Jan 2020New Brochures Now Available
April 2019
Another Satisfied GxP Supplier
GAMP 5® / 21 CFR Part 11 / Annex 11 & 15 / Culture Improvement:
"Thank you for your work so far, it has accelerated our understanding dramatically. We look forward to moving further along with this project and will touch base with you in a couple of weeks to give you an update on where we are with the [Project]...."
General Manager
Confidential UK GxP Supplier
Feb 2019
Refreshed ZES Website With New Layout And Page Content
The site now includes changes to navigation, with drop down menus from the top of the page. We’ve also improved the structure of our content, so you’ll get more from a quick read. ZES have also included a host of new graphics and included a few updates that have made the site easier to use.
More case studies have been included, to provide a greater in sight into the services provided by ZES.
ZES hope you like the changes and if you have any feedback, please let ZES know.
Dec 2018
FDA Release Further Data Integrity Guidance
If you need help implementing policies and procedure to achieve a good level of compliance, ZES experts are happy to help. Download the guidance here:
Dec 2018
Another Satisfied Medical Device Manufacturer
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
Nov 2018
ZES Attend The MHRA Symposium In London
• Deficiency data
• The Falsified Medicines Directive
• Application of current GMP to new technologies
• Annex 1: Post Consultation Update
• Importation
We also had an opportunity for Q&As to the MHRA panel.
Very well done to all concerned! See you next year!
Sept 2018
Updated Training Courses : Validation / SOPs
All our courses are bespoke and tailored to our clients' needs.
If you would like bespoke training, delivered by industry experts on your site, then contact ZES.
June 2018
Two New ZES Videos : GxP Cloud Projects
ZES have released two GxP cloud project videos which highlight ZES services provide to GxP companies, thinking of utilising the cloud for GxP operations.
April 2018
New Case Study : Supplier Selection Process
March 2018
MHRA : GxP Data Integrity Guide Published
The guidance serves to clarify the UK regulatory interpretation of existing computer system validation and data integrity requirements. The scope of this guidance is designated as ‘GxP’.
A copy is available to download below:
August 2017
Refreshed ZES Website With New Pages
The site now includes changes to navigation, with drop down menus for both mobile and desktop versions. We’ve also improved the structure of our content, so you’ll get more from a quick read. ZES have also included a host of new graphics and included a few updates that have made the site easier to use.
ZES hope you like the changes and if you have any feedback, please let ZES know.
Jan 2017
New ZES Case Study Brochure
(4 Assignments)
Mar 2016
New ISO13485:2016 - More Stringent QMS
ISO 13485:2016 supersedes earlier documents including EN46001:1997 and EN46002:1997, ISO13485:2003, and ISO13488:1996.
Compliance with ISO13485 is seen by ZES as the first step in achieving compliance with European regulatory requirements.
ZES specialise in the conformity of Medical Device manufacturers operations to Directives 93/42/EEC, 90/385/EEC and 98/79/EEC before sale of a medical device. ZES are experts in the implementation of ISO13485 compliant QMS systems.
If your organisation needs expert advice, please contact ZES.
Oct 2015
New Brochure - FDA / MHRA GxP Inspections
July 2015
ZES Director To Speak At The IHEEM Conference
This year we are utilising the knowledge and expertise of our members and technical platform groups. We have put together a programme covering a range of topics and technical content ranging from decontamination and sustainability to medical gasses and water, plus much more. The diversity on offer really does highlight the vast amount of knowledge within IHEEM and we are keen to share this with our members Julian Amey, Chief Executive, IHEEM and any non-members who have an interest in healthcare estates.
So please join us at the IHEEM Technical Theatre for a lively debate of the issues that matter.”
Chief Executive
IHEEM
April 2015
Managing Medical Devices Update
The purpose of this MHRA document is to outline a systematic approach to the acquisition, deployment, maintenance (preventive maintenance and performance assurance), repair and disposal of medical devices and medical device training.
It is intended primarily for people in hospital and community based organisations that are responsible for the management of reusable medical devices, to help them set up and develop systems that promote the use of the medical devices for safe and effective health care. This document replaces the following:
- DB 2005(03) Guidance on the safe and effective use of batteries and chargers for medical devices, October 2005.
- DB 2006(05) Managing Medical Devices. Guidance for healthcare and social services organisations, November 2006
Download Version 1.1 below:
Sept 2014
Director To Sit On 'the RCT' Management Panel
The Register of Clinical Technologists (the RCT) – formerly the Voluntary Register of Clinical Technologists – was formed in 2000 with the aim of protecting the public by advocating statutory, professional regulation for Clinical Technologists.
The Register now holds the details of almost 3000 healthcare professionals who have achieved the standards set out by the RCT through education or equivalence. They abide by a regularly reviewed Code of Conduct and take part in Continuous Professional Development to maintain their professional status.
ZES Director David Easton is pleased to accept a position on the RCT management board and to assist the register in their work.
July 2014
ZES Provide CAD Services For New GMP Facility
Working with a strategic partner, ZES are providing CAD services for a new GMP facility.
In due course this will be detailed as a case study.
Legacy News Items
For older news items, please contact the ZES office:
