Validation with SAP Solution Manager

FDA 21 CFR Part 11 compliant
validation documentation

SAP Solution Manager

Validation with SAP Solution Manager

As experts in the life sciences and medical technology, we always strive to find and provide optimal solutions for our customers. It quickly became clear to us that SAP Solution Manager is an optimal tool for supporting SAP ERP and SAP S/4HANA projects.

To close the functional gaps of the SAP Solution Manager in the regulated environment, we have developed the DHC Add-On for SAP Solution Manager – Solution Documentation and DHC Add-On for SAP Solution Manager – Change Request Management to enable a paperless and FDA 21 CFR Part 11 compliant use.


Our proven DHC validation method is adapted to the conditions of companies in the regulated environment and to industries that place high demands on the quality of their production, quality and IT processes. We consistently implement this method in SAP Solution Manager.
In addition to our Starter Packages, we have developed tried and tested add-ons for the life sciences and medical technology sectors that enable the use of SAP Solution Manager in a regulated environment. This enables us to provide you with a carefree introduction to the use of SAP Solution Manager even in a regulated environment.

All important documents are managed paperless as Electronic Record in SAP Solution Manager. Approval of documents for validation or change request management is carried out by an FDA 21 CFR Part 11 compliant electronic signature.
With DHC, you have a partner with over 20 years of consulting experience in the validation and implementation of SAP ERP.


Basically, the validation of large and complex systems, such as SAP ERP or SAP S/4HANA, is very time-consuming, since a large number of documents are generated, which of course have to be managed over the entire life cycle of the IT system. Within the framework of test management, it must be ensured that the entire functionality of the SAP ERP or SAP S/4HANA system functions exactly as described in the requirements specification. These test activities must be permanently monitored and it must be ensured that the errors found are rectified in a documented manner. In addition, operational processes must be established for validated systems, such as Incident Management and Change Management.

The more you support these processes electronically, the fewer errors will occur in operations. Especially in quality assurance, costs can be saved massively, since much less effort is to be expected when checking and, for example, revising documents.
We asked our webinar participants where they saw the greatest advantages in the electronic validation of IT systems as opposed to paper-based validation. The biggest advantage is seen in the central access and the constant availability of the documents. This is followed by a leaner document management process, since the effort for printing, collecting signatures and possibly scanning the documents as well as storing the documents is also eliminated.

Get more information!

Request more information and podcasts about DHC solutions with SAP Solution Manager without obligation!


Take advantage of our experience and industry expertise in all aspects of SAP Solution Manager

  • Since 2004, we have accompanied our customers in the introduction and implementation of SAP Solution Manager. This has enabled us to build up a high level of SAP Solution Manager competence. Especially for the implementation of SAP projects, we have successfully relied on the support of the SAP Solution Manager for years.
  • With our DHC Starter Packages for SAP Solution Manager, we provide you with standardized best practice processes for Solution Documentation, Test Management, Change Management and Incident Management, which provide you with the best possible support for your SAP ERP and SAP S/4HANA projects.
  • The reference processes we have developed for SAP Solution Manager are based on the internationally recognized standards ITIL v3 and ISTQB.
  • With additional add-ons for Solution Documentation and Change Request Management, we fulfill additional requirements, which are particularly high in industries with high quality requirements.
Contact person Germany
Matthias Bothe

Managing Director & Industry Unit Manager
Life Sciences, Chemie and Medical Engineering
phone: +49 681 93 666 0

Matthias Bothe, DHC GmbH
Contact person Switzerland / Austria
Carsten Buri

Director Sales & Marketing
phone: +41 44 500 888 7

Carsten Buri, DHC AG



23. September
LSA Webinar (in German)

Mobile defects recording and deviation management in SAP S/4HANA

We will show you the apps available in the SAP standard for recording errors and deviations.

30. September
Info Day (in German)

SAP Info Day: Integrated CAQ with QM Solutions from SAP and Partners

Register now for the free web session on the DHC customer project “Global Quality System with SAP QIM at Meyer Werft”!

07. Oktober
Webinar (in German)

SAP S/4HANA Implementation and Validation in Life Sciences

Find out what benefits the LSA approach offers you for the optimal, validated deployment of S/4HANA.

15. Oktober
Webinar (in German)

VxP, the cloud-based Validation Platform for the Life Sciences

With VxP, DHC offers a cloud-based validation platform to accelerate validation processes and digitalise documentation.

22. Oktober
Webinar (in German)

Test equipment management and monitoring

Presentation of the test equipment management integrated in SAP with all functions for the company-wide management of operational test equipment.

04. November
Webinar (in German)

SAP S/4HANA Transformation and Validation in Life Sciences

Learn everything about phases for the system transformation (system conversion) of an SAP ECC to S/4HANA with integrated validation.

26. November
Webinar (in german)

APQP, FMEA and PLP with QM solutions from SAP (SAP QM)

Presentation of the various SAP tools for mapping APQP and presentation of SAP PPM, FMEA, control plan, inspection plan and quality notification

09. November
Life Online Training

SAP: Validation and GMP Compliance (Live Online Training der ECA Academy)

Online training with speakers from DHC GmbH, organised by Concept Heidelberg on behalf of the ECA Academy,


Our webinars are provided as a free service for DHC customers and potential customers.