A vendor audit is a vehicle used by pharmaceutical companies, and other large companies as well, to inspect and evaluate a vendor’s quality management system, as well as its practices, products, and documentation. The need to conduct vendor audits stems from a higher need for quality control in an industry that needs to be more regulated than any other industry in the world. This need for a closer monitoring of a vendor’s qualities and practices stems from an ever-evolving quality control market, and an industry where quality products are a necessity, not a luxury.
One reason why organizations use audits is to reduce cost and improve quality control. They do this by creating the leverage of expertise of product and service providers as an alternative, instead of building equivalent capabilities in-house. This way of outsourcing partnerships between pharmaceutical companies and external pharmaceutical vendors has reached the top of many companies’ strategic imitative plans in recent years. This system of vendor auditing is being used by different companies, in different industries all over the world, but has really gained ground as a reliable business principle in the pharmaceutical industry.
The FDA requires that all inherent systems used to support agency regulated activities need to be validated and compliant with FDA rules and regulations. In more precise words, the system administrator is responsible for demonstrating that the application that was developed and tested is operating and maintained according to FDA quality control standards. In addition to this, the system administrator needs to be able to demonstrate the proper use of the procedural and technical controls, and that all applicable regulations are met.
The primary areas that need to be evaluated in a vendor audit are vendor viability, management responsibility, system accuracy, and data integrity. The main objectives for a vendor audit are to assess the quality management of the whole organization, through its procedures and data processes. It is an assessment of quality control measures taken by the vendor to assure that their products and services are acceptable for business transaction. During this audit they will also verify computer systems developed or used by the vendor, make sure they meet all of the regulatory requirements, as well as have the testing documentation requirements.
A vendor audit should not be only limited to making lists of good or bad things. It should be looked at more as an overall assessment of finding, from which you can draw your own conclusion. A vendor audit should be conducted to help your organization make quality decisions about services, products, vendors, and quality practices. It will provide your company a means to verify that third party vendors meet the applicable FDA laws and regulations, while reducing liability and effort on your part.
When done correctly a vendor audit can provide a great value to your company and organization, especially, in the system implementation and validation process. It allows for vendors and buyers to quickly establish relationships that will not only increase product quality, but reduce duplicated testing efforts, and start a new and constructive dialogue between buyer and vendor. To learn more about how to properly administer vendor audits in your company, contact a leading pharmaceutical consultant in your area.
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