Gyrolab Notification Service

Gyros Protein Technologies AB operates using an ISO 9001 certified Quality Management System and change control is a critical part of that system. All changes are managed through a change control process and are documented and tracked.

Since many of our customers work in regulated environments, we offer access to change control information through our customer notification service. By subscribing to the service, you will be notified by email of changes to a product, related documentation or its manufacturing process.

Each change will be analyzed and evaluated to determine if the change should be subject to notification. Examples of changes that may be notified:

  • Product issue/complaint requiring re-engineering or change (CAPA)
  • Change of critical components
  • Critical raw material changes in kits, CDs and consumables
  • New version of instruction for use
  • New/revised maintenance routine
  • New software versions
  • Change of maintenance routines
  • Change of specifications
  • Change of packaging and labeling
  • Change of manufacturing site

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