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

Want to Utilise the Cloud for GxP Applications?

  • by Zener Engineering Services Ltd
  • 25 Oct, 2020
GxP Cloud GMP Cloud

The amount of electronic information (data) computer systems generate continues to grow significantly. Industry is always looking for better, cheaper and faster solutions. Outsourcing to specialised firms who can provide IT solutions more efficiently, who can leverage technology to improve information handling, is increasingly attractive and of interest to GxP companies.

Cloud solutions in a GxP environment present a number of regulatory challenges.

Zener Engineering Services can determine and document the validation approach to be adopted depending on the inner workings of the cloud-based application. Depending on the cloud service model, the vendor may be responsible for some of the validation activities. ZES can determine and document boundary lines, roles and responsibilities to help ensure a successful project.

Zener Engineering Services validation engineers will help ensure system requirements are tested, are suitable and are to the required regulatory standard.

FDA / MHRA expectations do not change in an outsourced environment,
including the utilisation of a GxP cloud solution.
Changes to the chain of command, roles and responsibilities, for a GxP cloud solution,
must be documented by the GxP Company.
Cloud solutions in a GxP environment present a number of regulatory challenges. Global regulators are interested in the growing utilisation of cloud environments. Regulators are not averse to cloud computing, but like all new “hot topics” they need to understand the risks and required controls, as does the GxP Company and its Suppliers.

ZES can determine and document the validation approach to be adopted depending on the inner workings of the cloud-based application.

The cloud solution provider’s involvement must also be taken into consideration when determining the activities required during the validation life activity of a cloud-based solution. Depending on the cloud service model, the vendor may be responsible for some of the validation activities. ZES can determine and document boundary lines, roles and responsibilities to help ensure a successful project.
ZES validation engineers will help ensure GxP cloud system requirements are tested,
are suitable and are to the required regulatory standard.
Contact ZES with all your GxP Cloud concerns and requirements.
Banana on Road

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: