Using Maximo® & Fingertip to help Guerbet with FDA & HRPA compliance

IBM Maximo^® & Fingertip Calibration Module enable seamless calibrations and inspections in the field.

Guerbet is a global leader in medical imaging, based in France. They manufacture products and solutions for diagnostic and interventional radiology.

As part of this work, they use IBM Maximo^® software to manage their assets, helping them to improve productivity, ensure health & safety compliance and high-quality standards are maintained throughout their organisation.

This involves managing their assets safely and efficiently in hazardous environments.

Reducing the paper trail

Guerbet contacted Peacock Engineering because their current version of Maximo^® was outdated, and they wanted a more supportable version with all the latest features.

This additional functionality was required to further improve asset management within their hazardous environments.

They specified that this new solution needed to be:

Safe to use in hazardous environments
Able to send ‘work orders’ when faults detected
Entirely paperless
Accessible on a mobile device, on or off-line
Compliant with industry standards & ATEX regulations
Easy to use, read & understand for all staff

Peacock Engineering worked with Guerbet to get a clear sense of what they planned to use this new solution for. That way, we were able to make an informed, useful recommendation that maintained their ability to comply with FDA and HPRA regulations.

Improving efficiency

The project target was to upgrade to the very latest version of Maximo^®. As part of this, our Fingertip solution was selected, therefore providing industry-leading benefits that they could not get anywhere else. We worked with Guerbet to implement this Fingertip solution for Maximo^®. It is now:

Installed with mobile forms, ensuring work processes are followed
Paperless, mobile calibration and work-orders

Off-line mobile use, allowing safe use in hazardous environments (ATEX, zone 1 & DSEA)
High data quality ensured
Easy-to-use, with audit trail

As a result of Fingertip’s accessibility, Guerbet technicians can now carry out Instrument Calibrations & Inspections with optimum efficiency. They receive automated updates every time a work order is completed.

Guerbet also decided to deploy the IBM Cognos solution, which enables their team to have real-time, business intelligence (BI) reporting.

Validation

A critical objective of the project was to ensure that self-certification was in complete compliance with all appropriate regulatory requirements (see specifications below).

Coordinating go-live across the world

As part of this project, Peacock Engineering worked with many of Guerbet’s discipline teams across the world, including India, France, Ireland, USA and the UK. The system was deployed quickly, safely and in compliance with all regulations.

Result: efficient, accurate, compliant and cost-effective

The upgraded and enhanced solution allows Guerbet to maintain its assets more cost-effectively, more efficiently, with a high level of accuracy, ensuring the integrity of it’s calibration & inspection programmes.

Print or download this article

Technical & Validation Specifications

Major Upgrade from IBM Maximo^® v7.1 to v7.6
Fingertip Mobile Solution from Peacock
Fingertip deployed on ATEX zone1 handheld devices
Fingertip Calibration Module was implemented to support Guerbet’s complex business processes
IBM Cognos Analytics business intelligence and reporting tool
Used Peacock’s tried & tested validation process to meet stringent requirements

Software validation to give compliance with:

FDA Title 21 CFR part 11
Health Products and Regulatory Authority (HPRA)
EU Annexe 11
Irish Health Products Regulatory Authority
International Society of Pharmaceutical Engineers (ISPE) Good Automated Manufacturing Practice (GAMP 5) regulations, rules and guidance

What our clients say:

… What sets Fingertip Inspections and Calibrations apart from any existing mobile system is that it is fully integrated into Maximo^®. This is a key product differentiator as the data is being captured as the maintenance task is being done. This data is immediately available to all system users including those responsible for managing asset integrity. This fully integrated system enables better management and control of maintenance costs”. “Incidentally, Fingertip runs on the intrinsically safe Aegex10™ Windows enabled tablet at Guerbet (Dublin)”

Brian Doyle of Hazardous Risk Solutions, who is leading the development of Guerbet’s Maximo^® System and project managing the implementation of Maximo^® 7.6 and the deployment of Fingertip