January 25, 2016

Specification Control

 

The FDA requires that manufacturers include specifications for verifying the identity of incoming and outgoing materials. InstantGMP™ includes a specifications module that allows users to review and sign off on specifications any time, any where.

  • Specifications for raw Materials or incoming WIPs are tests completed that prove purity, strength, identity, general physical properties, or fitness for use in production
  • Specifications are required for Materials used to produce Medical Devices, Dietary Supplements & Pharmaceuticals
  • Though they are not yet required for producers of E-Liquids, it is strongly recommended to start to use specifications
  • A sequential version number is automatically assigned when a Specification is added for material part number
  • Users have the ability to insert, update, and delete tests
  • Different versions of a Material Specification may be used concurrently in different Master Production Records & Device Master Records
  • Exportable and printable