Training Management

Extend the “Document Control” module to include active planning and logging of your employees‘ qualifications. Our solution „Employee qualification management“ takes on this task.

Your benefits

  • No manually maintained Excel lists to display the qualification matrix – our solution does the work
  • Assurance that only successfully trained employees can perform the corresponding activity
  • Comfortable evaluation of the qualification level based on a document, an employee or a qualification profile
  • With the additional use of our module “Controlled Documents”, the release of a new document revision automatically generates the corresponding training tasks

Details

  • Support of document trainings, face-to-face trainings and external trainings
  • Optional learning success control based on multiple choice tests
  • Configurable repeat rhythms
  • Automatic creation of training sheets and certificates of participation
  • Automatic assignment of relevant documents in case of department change

Regulatory requirements

  • ISO 9001:2015, chapter 7
  • ISO 13485:2016, chapter 6
  • EU GMP Guideline Part 1, chapter 2
  • EU GMP Guideline Part 2, chapter 3
  • Ordinance for the Manufacture of Medicinal Products and active Pharmaceutical Ingredients section 2, §4
  • FDA 21 CFR 211 Subpart B

Quick contact

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