Digital Signatures

DS

Digital Signatures

DS

Verify documents and complex PLM objects faster and meet regulatory requirements

Verify documents and complex PLM objects faster and meet regulatory requirements

Advantages for enterprises and employees

  • Speed up circulation procedures for verification and approval processes
  • Meet regulatory requirements and improve validity control and process reliability

Speed up circulation procedures for verification and approval processes

You can use CONTACT Elements Digital Signatures to stem the flood of paper at your company and speed up processes due to the immediate availability of electronic documents. Define automatically initiated verification and approval workflows for selected documents, e.g. when there is a change in status, and have them signed using a verifiably valid digital signature. This ensures the traceability of your processes and enhances their quality.

Sequential and parallel signatures – avoiding media discontinuities
Digital Signatures significantly speeds up multi-step verification and approval procedures in particular. In cases such as these, you can combine predefined parallel workflows with signing tasks. The user who has been assigned a signing task will see this task in his Task Manager and can execute the signature in the Task Manager itself. By avoiding media discontinuities, you can simplify and accelerate circulation procedures while at the same time providing better protection. When it comes to coordination processes that involve multiple departments or even globally distributed sites, the advantages could hardly be any clearer.

Digitally sign documents and ensure their validity

Meet regulatory requirements – improve validity control and process reliability

CONTACT Elements Digital Signatures also provides you with benefits when it comes to increasingly stringent regulatory requirements. Digital signatures are already being recommended in the automotive industry when transferring data via the OFTP2 transfer protocol. They are also accepted by the FDA for strict manufacturing and documentation processes. Digital Signatures allows you to meet the requirements stipulated in the FDA standard 21 CFR Part 11 relating to electronic records and electronic signatures and the corresponding EU directive on electronic identification.

Internal and external signatures on documents and complex data objects
You can apply CONTACT Digital Signatures to both electronic documents and straightforward data objects or a combination of the two. Standardized output formats for digital signatures are PDF documents and XML files that can viewed using any browser. Have partners sign contracts or the relevant internal staff and external customers sign requirements or complex structures, for example; released version of articles, together with their BOMs, can also be validated using a digital signature. You benefit from verifiable and legally compliant internal and external signature processes, enhanced process reliability, accelerated procedures, cost savings and protection against fraud.

Ensure compliance with OFTP2 and FDA and EU standards with CONTACT Elements Digital Signatures

Requirements defined in Regulation (EU) No 910/2014 and implementation of OFTP2 and FDA 21 CFR Part 11

A multitude of laws, guidelines and directives regarding consumer protection, product liability, environmental and quality management mean that companies in regulated industries have to meet stringent regulatory requirements – this applies not only to the financial industry but also to the automotive, air transport, energy, health care, life science and pharmaceutical industries. Companies in these industries therefore have to commit considerable resources to ensuring that processes meet these requirements in a traceable manner and providing appropriate certification, as well as guaranteeing that contracts are legally valid. After a brief definition of the terminology used and a description of how digital signatures work, this white paper discusses the legal specifics of digital signatures. This is followed by an introduction to two directives from regulated industries that stipulate the use of digital signatures, namely the OFTP2 transfer protocol and 21 CFR Part11. Finally, this white paper describes the possibility of integrating digital signatures in PLM processes and the resulting benefits for companies.

Download White Paper now!

Related topics

Intelligent document logistics: organizing and utilizing know-how enterprise wide

Make all important documents available on every workstation

Save valuable time when searching for documents

Protect valuable know-how

Speed up test and release processes

Comply with regulatory requirements much more easily

 

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