The client is a leading, research-based pharmaceutical company that has commercialized more than 20 innovative medicines for different diseases.
Challenge
The client relies on different vendors, contractors, and suppliers to meet business needs. In order to standardize processes and tools, the client conducts periodic audits to qualify partners’ applications, services, and GMP (Good Manufacturing Practice) or IT systems—making sure everything complies with complex regulatory frameworks and requirements.
However, as their company grew, the client experienced challenges in conducting thorough audits and managing all third-party providers. Failure to meet regulatory requirements poses risks to product quality, patient safety, and data integrity.
Solution
Orion supported the client’s qualification process by executing IT GMP vendor audits on their behalf. Based on risk assessments, Orion, in consultation with the client, determined the type of vendor audit. We defined the audit intake process using intake forms, vendor assessment forms, audit report templates, etc.
Orion conducted audits of the client’s major suppliers, utilizing a detailed vendor audit checklist to increase audit efficiency and accuracy. Auditors involved received periodic training in applicable processes and remained up to date with global regulations.
Audit findings, criticality, noncompliance, and recommendations were also documented and shared with the client for review and finalization. These reports were delivered within a month of the assessment date, along with periodic status updates and KPI metrics. Orion also offered an audit tracker system for clients to log in and check the status upon request.
Impact
While the engagement started as a pilot project, Orion quickly became a major partner in supporting the client’s vendor audit program, increasing the number of audits executed by over 400% in two years. Orion successfully supported the third-party vendor audits for the client within the expected timeline, ensuring regulatory and process compliance.
The client was able to reduce workload and costs without compromising quality. Additionally, the client was able to mitigate potential compliance and quality issues with more visibility into vendor risks and recommendations. They were able to continue business as-is with qualified vendors, increasing quality and operational confidence in suppliers. These benefits streamlined processes, drove success, and enabled the client to reinforce trust in their customers.
