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


Blog Post

Zener Engineering Services Ltd Logo

Medical Device 510(k) Clearance - Cyber Security

  • by Zener Engineering Services Ltd
  • 13 Jun, 2019
A Medical Device manufacturer required support with an FDA 510(k) Clearance for a new medical device utilising artificial intelligence.

To read the full article click here.
Medical Device Cyber Security Training delivered by Zener Engineering Services

Share This Post

by Zener Engineering Services Ltd 13 November 2024
A 'well-established' cleanroom supplier proposed cleanroom fans unsuitable for a new sterile manufacturing facility, required by a Cell and Gene Therapy Client
by Zener Engineering Services Ltd 22 October 2024
The importance of the critical role performed by Authorising Engineers (AEs), can't be overstated.
by Zener Engineering Services Ltd 2 October 2024
NHS refreshed using ZES Mugs, one drop at a time.
by Zener Engineering Services Ltd 15 September 2024
A successful GxP Data Integrity training strategy is an ultimate goal for any Life Science Organisation
by Zener Engineering Services Ltd 22 August 2024
A successful GxP Calibration Management training strategy is the ultimate goal for any Life Science Organisation
by Zener Engineering Services Ltd 1 August 2024
Significant skills are required to implement compliant solutions, to satisfy the regulatory requirements of 21 CFR Part 11 and to ensure Data Integrity of Electronic Data.
by Zener Engineering Services Ltd 19 June 2024
Three New GxP Training Courses: ERES, Data Integrity And Calibration Management
by Zener Engineering Services Ltd 30 May 2024
A successful regulatory outcome is the ultimate goal for any Life Science Organisation
by Zener Engineering Services Ltd 8 May 2024
Various GxP Computer System Regulatory Requirements state that the integrity of the data held on such systems, is to be protected by a level of security that prevents tampering with records, or other unauthorised changes to ‘cover’ potential poor practice.
by Zener Engineering Services Ltd 19 April 2024
Effective documentation is the backbone of any successful Life Science organisation, whether it's creating manufacturing records or policies and SOPs.
Show More
Share by: