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21 CFR Part 11

Make your qualification processes compliant in accordance with 21 CFR part 11

Companies in highly regulated industries have an obligation to inform their employees about, and how to adhere to, legal regulations. Therefore training certificates as well as IT-supported compliance processes are key elements of regulatory audits.

21 CFR part 11 of the American Code of Federal Regulations, published by the Food and Drug Administration (FDA), governs all the requirements applicable to IT in the fields of pharmaceuticals, healthcare and the foodstuffs industries. The focus here is on tougher security requirements for digital signatures and electronic recordings which, not least, the e-learning infrastructures of the companies concerned must live up to. In addition, European providers and suppliers to these industries, who sell their products in the USA, are obliged to align their processes and training concepts with the requirements of 21 CFR part 11.

IMC Learning Suite enables organisations to comply with FDA requirements by managing, optimising and certifying holistic compliance processes.

In concrete terms, that means:

  • Improved identity management
  • High process transparency
  • Precisely documented course participation
  • Precise reporting
  • Maximum security standards with data storage
  • Reliable e-signatures

Is your company also faced with the challenge of fulfilling the legal requirements of 21 CFR part 11?

IMC Learning Suite supports your company with the implementation of all requirements arising from 21 CFR part 11. All auditable documents and evidence is automatically checked by our Learning Management Ssytem to ensure it is up to date, and then filed. Access to the data is possible at any time. Thanks to IMC´s Learning Suite’s precise implementation of the requirements of 21 CFR part 11, the time-consuming search for paper and participation certificates are a thing of the past, saving your company valuable time and resources. Our LMS guarantees auditable documentation and reliable digital reporting of all your employees’ learning activities. E-signatures enable a system of digitalised identity management in accordance with the most stringent security standards.


Discover all the benefits of our tried-and-tested e-learning solution:

E-signatures

The entry of individual user data to confirm a process guarantees secure identity management and minimises the risk of misuse.

Digital training verification

Because our LMS updates course registration, participation and modules passed in real time, you can retrieve the information at any time and you will always be up to date with the learning and compliance achievements of your employees.

Audit trails

All actions and processes initiated are logged electronically in the LMS. The IMC Learning Suite keeps all information regarding user behaviour well documented and readily available.


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