ELECTRONIC RECORDS/ SIGNATURES

Our team of experts will provide you with competent support in creating data catalogues, classifying them, carrying out detailed analyses and making decisions for or against electronic signatures.

…read more

Annex 11 and Chapter 4 of the EU-GMP Guideline define the requirements for electronic records and signatures for pharmaceutical manufacturers

If regulated companies want to use electronic signatures, they must create organizational and technological preconditions that enable their use. The Signature Act (SigG), the Annex 11 to the EU GMP Guidelines and 21 CFR Part 11 define the corresponding regulatory requirements.

Types of technical signatures (SigG)

  • Simple electronic signature
  • Advanced electronic signature
  • Qualified electronic signature

Types of technical signatures (Part 11)

  • Electronic signature
  • Digital signature

In relevant texts, the “normal” signature or the hand mark “signum” is required, i.e. in most cases a simple electronic signature is sufficient to fulfil the required specifications. Currently, the “written form” and thus the qualified, electronic signature is considered mandatory only in exceptional cases. Furthermore, it should be noted that formulations such as “to be specified in writing” are not equivalent to the legal requirement of “in written form”.

It is precisely with this type of problem that we help create clarity with our services. In a large number of projects, we have provided the necessary transparency for similar issues and successfully developed and implemented solutions together with our customers.

We can support you with:

  • Analysis of business areas (and systems) with regard to the use of electronic signatures
  • Clarification of the required type of electronic signature / signature
  • Creation of organisational prerequisites
  • Create advisory documentation and templates that represent the standard of the company
  • Training (awareness and detail training, workshops, coaching)