In October 2020, the Life Sciences Division launched an innovative project for its largest customer in the pharmaceutical sector: a deviation platform.
What are deviations and what is a deviation platform?
A deviation refers to any event differing from the approved or expected standard, procedure, or process in the pharmaceutical industry’s quality system. Four types of deviations exist: critical, major, minor, and incident, depending on the impact they have on the product quality and the safety risks they might cause. They can occur at various stages of the product’s lifecycle (sampling, testing, manufacturing, etc.), and each deviation must be documented complying with GMP regulations.
The aim of a deviation platform is to support the management of those deviations, by a team of consultants. They manage the deviation from A to Z: investigation, root cause analysis, impact analysis, and proposition of actions (immediate, preventive, corrective) to avoid recurrence.
The creation of the deviation platform
Over the years, the Life Sciences division within ALTEN acquired a huge expertise in quality management, centralised within its technical department, and noticed a growing need of support in managing deviations. In addition, prospecting meetings with technical and purchasing managers enabled the business managers to share this expertise and the added value ALTEN could bring them. Thanks to this mutual work, the Life Sciences division was able to set up a pilot platform for its largest customer, before winning a 3-year contract.
What are the benefits of a deviation platform?
For the customers, this kind of platform can be helpful and time-saving: ALTEN can absorb the workload related to deviations, allowing them to focus on their core business activities (production, continuous improvement, etc.). Consultants can work in various manufacturing and support units, like quality control laboratories, material reception, calibration, and measurement.
The deviation platform has many advantages for our client:
- They can take care of core business activities without having to deal with deviations management
- It increases their internal/external agility
- They oversee and continuously improve on supplier performance & development management
For ALTEN, the deviation platform allows to establish a strong partnership and to increase confidence and visibility at the client’s site. It allows us to build an autonomous organisation within a project. This is also a great opportunity to recruit young graduates, offering them a real springboard for their career: they can go from deviations coordinator to team leader. By having an autonomous platform and having gained the client’s trust, this type of model also allows us to offer support for other activities related to deviations (such as CAPA) and thus diversify the activities of the consultants on the platform.
Today, the project has grown so much that the team has expanded from 6 consultants when it first started, to 34 in 2022. ALTEN is proud to be considered as a real partner, specialised in quality systems for the pharmaceutical industry.
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