Selecting a vendor is always a challenge, as it requires thorough evaluation and very often, a vendor audit. Audits are time consuming and with limited resources both the quantity and the quality of the audits are at risk. In addition, the increased focus of health authorities on CFR21, Data Integrity and GDPR requires the auditing part to have potential inspections in mind.
A vendor audit is an integral part when selecting a vendor for critical systems within pharma, biotech and medical devices ensuring data integrity and adherence to regulations such as GDPR, CFR21 Part 11, and ISO. Conduct of a substandard or even lack of conducting an audit may result in findings during Health Authority inspections or exclusion of data in studies due to incorrect handling of data. We can support you from the initial project analysis phase up until vendor selection to ensure that the Request-for-Proposal and Vendor Questionnaire is fully backed by a thorough vendor audit.
A thorough and documented vendor audit is one of the main benefits of selecting HERAX as your preferred vendor auditor. By ensuring a thorough vendor audit, you as a company will benefit from complete due diligence of the vendor, verification of vendor’s ability to ensure data integrity, and that the vendor processes and documentation can be defended during health authority inspections.
- Increased regulatory compliance
- Reliable selection of preferred system vendor
- Increased standardization of audit procedure
- Increased quality and inspection readiness
- Comprehensive information on system vendor capabilities incl. areas of concern in relation to regulatory authorities
- Verification of the Operations and Maintenance capabilities provided by the vendor if SaaS solutions are in scope
- Verification of a quality-based System Development Life Cycle of the product
Target areas for audits
Our consultants have extensive knowledge of the entire Vendor Audit process. From the initial quality discussions with the potential vendor, to defining the audit scope, conducting the audit and create the audit reporting, HERAX can be your trusted Auditor. This process will allow your organization to better be involved in the audit journey.
We can assist you by combining a proven Life Science specific project methodology with a “best-in-class” knowledge of the vendor auditing as part of vendor selection.
Your partners in implementation
When appointing HERAX as your auditor for vendor audits, we will provide knowledgeable resources capable of performing the in-depth analysis of the vendor and encourage vendor selection based on detailed reports. This will support your organization when selecting the best vendor and verify whether all parties are capable of lifting the documentation burden in case of an inspection.