Leveraging your supplier is one of the five key principles of the GAMP 5 ‘Risk-based approach to compliant GxP computerised systems’. A guideline document - written for the industry, by the industry – GAMP 5 outlines how organisations can successful achieve project delivery within the life sciences industry.
Although it was produced in 2008, it is only now that we are seeing companies realise that this is a valid methodology for reducing the amount of audit / compliance work or validation testing that they have to do. In a nutshell, ‘leveraging your supplier’ is a key way of shortening the ‘go live’ cycle whilst using subject matter experts to aid the validation process.
So, what does ‘leveraging your supplier’ mean in practice?
Section 2.1.5 of the GAMP V documentation states:
2.1.5 Leveraging Supplier Involvement
Regulated companies should seek to maximize supplier involvement throughout the system life cycle in order to leverage knowledge, experience, and documentation, subject to satisfactory supplier assessment.
For example, the supplier may assist with requirements gathering, risk assessments, the creation of functional and other specifications, system configuration, testing, support, and maintenance.
Planning should determine how best to use supplier documentation, including existing test documentation, to avoid wasted effort and duplication. Justification for the use of supplier documentation should be provided by the satisfactory outcome of supplier assessments, which may include supplier audits.
Documentation should be assessed for suitability, accuracy, and completeness. There should be flexibility regarding acceptable format, structure, and documentation practices.
Here at PRISYM ID, we have definitive and structured testing practices, all based around standard software development lifecycle models. Our testing practices require that we produce a huge amount of evidence-based documentation. This allows our clients, when they come on board, to audit us, and then to use our documentation, which from a risk-based approach has been validated. This allows us to concentrate on the ‘Business Testing Case Studies’, which are pertinent to our client’s own business.
The major benefits are that this methodology cuts down what clients have to do, whilst using our subject matter experts to do most of the work for you. It could potentially shorten your validation cycle as well. We would encourage all potential clients to raise the potential of ‘leveraging your supplier’ right at the outset of the project.
After all, that’s what we are here to do, because we are the subject matter experts.
About the author:
Phil Dray is Senior Test and Validation Engineer at PRISYM ID, ensuring regulatory compliance to FDA, MHRA, EU and GMP for the company software products supplied to the Life Sciences Industry. He also ensures that validation documents and processes are in line with current regulatory guidance, and provides onsite training for PRISYM ID’s proprietary software for the Life Sciences industry.
He provides test plans and processes to ensure software products are robust before release.