The supply chain for FDA-regulated companies poses many challenges. Suppliers are considered an extension of the company and thus must be shown to be FDA-compliant themselves. They have to be evaluated, audited and monitored. Their shipments have to be tested for compliance with a material's specifications. Under very specific circumstances, exceptions from the written specifications can be made after appropriate review by the quality and engineering departments for which MasterControl offers supplier deviation management software. However, waiting for this assessment until after the shipment has arrived at your loading dock puts undue pressure on your quality department and creates unnecessary costs in the event that a delivery is declined.
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Many of MasterControl's regulated customers rely on our integrated supplier deviation management software to automate the process of collecting and controlling data critical to compliance. MasterControl supplier deviation management software creates a formal process where suppliers can request an exception to written specifications. Materials are shipped only after the appropriate individuals have reviewed and approved the request and provided proper justification.
The supplier deviation management software offers flexibility in terms of design, routing, and user and security roles to adjust to the way you work. It provides advanced tracking functionality, incorporates escalation, and offers best-practice features that prompt users with selected data to reduce data entry and avoid mistakes common in manual data entry. Captured data is stored in an ODBC-compliant database, enabling reporting and in-depth analysis through our powerful built-in Analytics tools.
Here's how MasterControl supplier deviation management software addresses some of the major challenges companies face in establishing and maintaining forms-based processes.
Supplier Deviation Management Challenges
Supplier Deviation Management Software Solution
Unavailability of Objective Data on Supplier Performance:
In environments without a formalized or with a paper-based supplier deviation process, objective data on a supplier’s performance can be hard to come by.
Collection and Analysis of Supplier Deviation Data:
MasterControl supplier deviation managemetn software stores all data on every requested supplier deviation. This data can be analyzed in detail and serve as an input to your supplier management program.
Arrival of Nonconforming Material at your Loading Dock:
Without a formalized supplier deviation management software, suppliers may ship rather than investigate in case of minor non-conformances. Processing at the loading dock and returning unacceptable material after undergoing the incoming QC process creates unnecessary costs and delays.
Communication of Issues before Material is Shipped:
MasterControl's supplier deviation management software allows a supplier to request an exception to specification before material is shipped. This eases the pressure on your quality department to accept the material and increases efficiency.
Inefficient Paper Forms System:
A paper-based forms process can be plagued with inefficiency and such issues as: filling out the wrong form, not completing the right form, and sending the form to the wrong person.
Cost-effective Automated System:
MasterControl automates forms-based processes such as supplier deviation and offers best-practice features that prompt users with selected data. It automates routing, notification, escalation, and approval for faster turnaround. MasterControl's supplier deviation management software is Web-based, so employees, customers, and suppliers can participate in forms-based processes (i.e., data input and verification) from virtually anywhere.
Poor Data Capture:
Forms in the supplier deviation management software are designed to gather accurate and complete information critical in compliance. With paper forms, the onus lies with the operator to input accurate and complete information, and then for an analyst to accurately transfer this information to a spreadsheet or other analysis tool.
Accurate Data Capture:
In creating new forms or improving existing ones, companies can use a variety of field formats for accurate and accelerated data collection. With a click of a mouse, a user can select common responses keyed in the form fields that allow a list of data options previously entered. This helps ensure data is entered correctly into the form. Fields in the supplier deviation management software can also be set up to calculate data using simple or complex math operations.
Manual systems don't connect forms-based processes (audit findings, corrective action, etc.), making continuous improvement almost impossible. For example, if the customer complaint process is not linked to the corrective action process, a critical complaint may languish indefinitely before it can be acted upon and remediation is initiated.
MasterControl's supplier deviation management software integrates different quality processes for more effective and efficient quality management. For example, a CAPA form can be launched directly from an OOS form, connecting one process to the next. Relevant information will be automatically entered into the new form, reducing data entry and avoiding mistakes common in manual transfer of information.
To have a detailed view of the supplier deviation management software by MasterControl, please feel free to contact MasterControl representative for more details.