Regulatory Requirements as the Basis for Supplier Quality Software
Supplier quality software in today's market is based on existing regulatory requirements that affect suppliers. In the U.S., the Food and Drug Administration (FDA) requires supplier audit for pharmaceutical, biotech, medical device, and other life science companies. It also requires medical device companies to maintain quality agreements with their suppliers.
In Europe, various directives and guidances call for supplier quality agreements. Life science companies that do business in Europe have to establish supplier quality systems that conform to those directives and guidances.
Whether in the United States or elsewhere, life science and other regulated companies are generally expected to maintain quality agreements that provide certain essential elements, which should also be reflected in their supplier quality systems:
- The agreement between the contract giver (sponsor) and supplier must be in written form; it must specify each party's responsibilities; and
- The agreement should ensure that records and documents are available and accessible to the sponsor;
- It should allow for visits to the supplier's facilities by the sponsor and regulatory bodies.
Monitoring Supplier Performance and Supplier Quality Software
Companies that use contract research organizations (CROs) and suppliers are responsible for monitoring the quality of the materials and services provided to them. The sponsoring company and its suppliers should agree on the means of monitoring, such as the use of key performance indicators (KPI) and performance audits. In both cases, the use of supplier quality software as platform for supplier quality management can be very helpful for sponsors and suppliers.
- KPI: Companies and its suppliers and CROs should agree on the criteria for their KPI, such as quality of work, productivity, timeliness, and efficiency. The criteria should be measurable. When looking for supplier quality software, look for the capability to track and report supplier and CRO performance issues.
- Audit: Most companies conduct audits to qualify their suppliers. Follow-up audits are just as important to monitor supplier performance. Periodically, the company should audit its supplier's quality processes and procedures for continuous improvement. Some companies choose suppliers that are ISO-certified, which means they undergo periodic audits to maintain their certification. Supplier quality systems should include an audit management process to facilitate regular follow-up audits.
How MasterControl's Supplier Quality Software Systems Can Help You
MasterControl's supplier quality software solution automates and streamlines the process for managing suppliers and for ensuring the quality of the materials and services they provide. MasterControl uses a web-based platform for supplier quality management so you can be connected with all of your critical suppliers regardless of where they are located.
Here are some of the benefits and features offered by MasterControl's supplier quality software solution:
- Automated Tracking: Unlike manual or hybrid supplier quality systems, MasterControl's supplier quality solution provides automatic tracking of supplier information stemming from audits, nonconformance reports, and CAPAs. This information is critical in generating supplier rating.
- Centralized Location: All quality information pertaining to your suppliers will reside in one place for easier tracking and retrieval. With MasterControl's supplier quality software solution, your users will have access to supplier quality information 24/7 from virtually anywhere.
- Connected Processes: MasterControl's supplier quality software solution allows you to connect the supplier management process with other quality processes for a holistic approach to compliance. For example, supplier nonconformances that are serious enough to warrant a corrective action can be automatically addressed via the CAPA process because they are all connected in the same system.
- Reporting Capabilities: A distinct advantage of MasterControl's supplier quality software solution over other electronic supplier quality systems is the capability to generate approved-vendor reports that include lists of the materials or services a supplier is approved to provide, the supplier's rating, and contact information. MasterControl has the capability to track and trend supplier quality events such as CAPAs.
For More Information on Supplier Quality Software Systems
To learn more about MasterControl's supplier quality software systems, contact a MasterControl representative.