Download this case study

CMC and Manufacturing Compliance

Leading global life sciences organization maintains GMP standards
by outsourcing supplier audits to elc group

Outsourcing its supplier audit programme to elc group allowed this leading pharmaceutical company to realize significant cost savings without putting quality or GMP compliance at risk

The challenge

“We’re able to help our supply chain manage risk out of their operations – which in turn benefits our business, and ensures there are no unexpected or nasty surprises along the way.”

Implement a cost-effective, scalable and timely supplier audit programme that would strengthen compliance across the entire supply chain.

Maintaining and managing its on-going key supplier audit programme was proving a resource-intensive burden for this leading global sciences organization. From scheduling audits in diverse territories, to providing appropriate remediation guidance to suppliers while maintaining its global knowledge base on fast changing compliance requirements, the company needed to find a way of implementing a robust supplier audit programme that would ensure commercial operations would be maintained with no risk of costly interruptions.

The company turned to elc group to deliver a more cost-effective audit solution that would maintain and strengthen GMP quality standards across the supply chain.

The solution

Replace the burgeoning in-house audit programme with a fully managed outsourced audit programme, saving costs with no compromise on quality or compliance.

Using elc group gave the company access to experts with years of industry experience, and a proven track record of success. A new supplier audit programme was scoped, defined and delivered – with access to as much or little resource as necessary to ensure key time frames are achieved, each and every time.

Alongside creating a manageable audit schedule, tailored to the exact business and compliance requirements of the life sciences organization, elc group provides a detailed report for both organization and supplier at the end of each audit. As part of this process, elc group identifies potential issue areas and opportunities for improvement and provides practical solutions and improvement plans for suppliers.

When it comes to supporting suppliers achieve compliance in a lean business environment, elc group extrapolates and evaluates specific audit findings from a global perspective to ensure the life services organization is able to maintain and refine the performance of its supply chain.

The result

“It would be true to say that elc group are experts in this business – they have tailored a solution that benefits us, our suppliers, and gives us a global view of how together we can manage and improve compliance across the supply chain.”

The elc group solution has delivered measurable cost savings, and created an audit programme format that targets and addresses potential risk before it becomes a problem. Audits are now completed on time, in a methodical and manageable manner, enabling the organization to reduce the number of full-time employees dedicated to the supplier audit programme.

In addition, the organization is now able to support suppliers with the provision of remediation plans that enable them to address potential risk areas which in turn ensures the supply chain is never unexpectedly interrupted.

The benefits of the tailor-made fully managed audit solution from elc group include:

Download this case study