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Pilgrim Adverse Event Regulatory Reporting Management

A Complete Regulatory Platform for Clinical and Post-Market Adverse Event Management for Drugs, Device & Combination Products

As globalization continues to press outward, regulatory agencies worldwide are looking to improve the efficiency of their operations and support early signal detection. As a result, regulations are changing, electronic reports are increasing, and the codes and the structure of how data is used, linked, and made available through product value chains will continue to expand. Pilgrim Software’s Adverse Event Regulatory Reporting Management solution will ensure that manufacturers are able to: maintain compliance; increase operational effectiveness; and, quickly identify product safety issues while avoiding risk and sustaining quality, now and as regulations continue to evolve.

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DSE - SSA

SmartSolve Synchronization Agent Data Sheet

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DSE - DEU

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DSE - ConnectorSAP

SmartConnect for SAP Data Sheet

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DSE - Supplier Quality Management

How effectively are you handling your suppliers? Is the quality level of your suppliers where you need it to be? How much is it costing you? Do you know when and which suppliers to assess based on your resource availability and the level you need to manage to? When it's time to source new products, which suppliers will be at the top of your list?

Pilgrim's Supplier Quality solution allows you to monitor supplier performance, manage your supplier quality information, and measure the cost of supplier quality effectively. Pilgrim's Supplier Quality solution features:

• Supplier Audits
• Closed-loop Supplier NCMR's and CAPA Process
• Supplier Deviation Requests
• Engineering Change Requests with critical Documentation Sharing capabilities
• Online Reporting
• Supplier Analyses, including Supplier Ratings and Scorecards

Applicable Industry: All
Applicable Solution: Supplier Quality Management

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