A vendor audit is a process implemented by pharmaceutical companies, and other large companies as for inspecting and evaluating a vendor’s quality management system, its products, practices and documentation.
1. Need for Vendor Audits
The growing requirement for vendor audits originates from the increasing need for quality control in an industry that requires to be more regulated than any other industries.
2. Purpose of audits
Organizations require audits to decrease costs and improve quality control. They utilize audits to reduce costs and develop quality control. They perform this by making the leverage of product proficiency and service providers as an option, instead of constructing equivalent capabilities in-house. This method of outsourcing business between pharmaceutical organizations and external vendors has reached the acme of a number of companies’ strategic imitative programs in years.
3. FDA validation requirements
According to the FDA validation requirements, all inherent systems, which are used to support agency-regulated activities, require being authenticated and compliant with FDA guidelines.
4. Audit compliance
The core area that requires to be validated in a vendor audit is vendor viability, system accuracy, data integrity and management responsibility. The major objective for a vendor audit is to review the quality management of the entire organization, through its processes and procedures. In the process of the audit, they will also check computer systems developed or made use of by the vendor for FDA/Audit compliance.
5. Vendor risk compliance
A vendor audit must not be limited to forming lists of positive or negative things. It is more like an assessment form. Instead of limiting it to making lists of good or worse things, it should be considered more as an overall assessment of discovering, from where you can draw your own conclusion.