Case Study: IT Infrastructure Qualification
The Challenge
Unexpected Driver for Change
In response to a ransomware cyber-attack, our client deployed a new VMWare solution to support their large-scale bulk manufacturing and packaging operation in the UK.
The new platform was robust and fast, but it lacked data integrity. The documentation showed clear deficiencies related to the regulatory expectations of the system as per predicate rules such as EU Volume 4 Annex 11, and compliance with the information security management standards such as ISO26001, ISO27001, ISO27002, CSV GAMP® 5, etc.
Our client was now under pressure to produce a compliant yet functional set of documents and procedural controls for their operations team. Despite a sizeable inhouse Computer System Validation (CSV) and Quality Assurance (QA) team, they realised that they were not going to be able to support commissioning and qualification of the new technology given the project deadline and several logistical and COVID-19 related delays.
They needed our support.
Our Collaborative Approach
Preparation and Cooperation
The Validation Factory is a consultancy of CSV professionals, specialising in volume documentation generation and IT infrastructure. The client brought us onboard to produce the required CSV documents in readiness for their internal Quality Management Systems (QMS).
The Plan
After taking the time to understand our client’s requirements, and agreeing on a budget, we put together a Computer System Validation Plan in which we would produce the specific CSV documents for the new technology.
The Process
Turn-key processes that are driven to yield excellent repeatable results
Working in collaboration with the client, we were able to quickly:
- form a cohesive and supportive team,
- gather important information,
- confirm architecture and design specifications,
- draw up the lifecycle documentation,
- align deliverables to the Standard Operating Procedures (SOPs) and
- make ready for the internal review/approval processes.
Clear, open communication at every stage enabled us to overcome the challenges caused by unforeseen delays (e.g. COVID-19).
We supplied our client with the exact CSV documentation they required, avoiding the need for them to write it from scratch or use CSV templates which subsequently helped them to process the work at a much faster rate than usual.
Once all components were delivered to site and commissioning complete, we were able to support our client to execute final design specification updates before protocol approval and execution. An interim release of the system for operational use allowed the protocol closure and reporting processes to be concluded concurrently saving time and money.
The Outcome
With extensive computerised system validation experience and industry knowledge, our clients can enlist our skills and services at any stage of a project. Our proven turn-key processes yield excellent repeatable results, and our validation packages are always ‘audit ready’.
After successful completion of the project, we continued to support the client in developing an optimisation and reporting programme. We developed structures and strategies for configuring alarm and event notifications, rationalising alarms for criticality across the IT infrastructure of the VMWare platform and network devices.
CSV Services for your IT Infrastructure
Outsourcing CSV proved invaluable to our client and post inspection the work completed on this project went on to form the framework of a large qualification programme.
The Validation Factory offers CSV services to pharmaceutical/biotech companies as well as those providing IT and Automation systems for regulated computer systems including manufacturing, laboratories, warehouse, packaging etc.
Contact The Validation Factory – Let’s talk about your project.
Author: Liam White, Validation Factory CMO
If you would like further information or help to get the ball rolling, give us a call or drop us an email.