Identify quality deviations and
develop measures to avoid them!

SAP Quality Management


No business process runs perfectly all of the time, which means quality deviations are part of day-to-day life. Deviations are not just part and parcel of production and logistics, however, but can also affect customer complaints or be related to vendors. Accordingly, every company needs processes and tools that can identify quality deviations early on when they occur, so as to track them, rectify them and – last but not least – avoid them in the future.

Deviations must be recorded and documented as part of a detailed description of the non-conformity/defect. Once the quality-relevant deviation has been confirmed, a detailed root cause analysis must then be conducted.

These causes form the starting point for identifying the measures required to perform corrections on the one hand and to implement preventive actions on the other.

Following implementation, the efficacy of these measures must then be assessed.

The life sciences industry in particular requires effective and reliable CAPA and deviation management. CAPA also forms part of the FDA and EU GxP guidelines, and is therefore relevant for manufacturers of pharmaceuticals and medical devices.

DHC digitalises CAPA processes in the SAP Quality Issue Management (QIM) module or with the help of quality notifications (QNs) in SAP QM. The advantage of the two solutions is full integration with SAP ERP, and therefore the avoidance of redundant data as well as error-prone interfaces.



Business Case
In the business case, we set out the arguments for or against the deployment of the QM module in SAP and about the scope in which the module could be cost-effectively deployed. We also provide answers to the question of costs as well as the benefits achievable by a SAP rollout. We therefore assess the compatibility of SAP QM functionality with your company’s quality management strategy and the appropriate business scope for deployment of the module.

We work with your QM experts to specify the field of application and application scenarios for the 8D system, while also defining a high-level strategy. The objective here is to identify an implementation recommendation in SAP, including a rough implementation plan. You can then use this deliverable to specify your roadmap and the next steps to take. This then serves as a starting point for all of the next steps in the project, from decision-making and implementation through to the final cutover to production.

Proof of Concept (PoC)
We use a feasibility study to compare your requirements with the functional and technical options offered by SAP QIM or SAP ERP with QNs, and assess the degree of fulfilment that this provides for the costs involved. This yields the decision document for or against SAP QIM/ERP with QNs. The proof of concept produces a recommendation as to whether SAP meets your requirements, what the pros and cons are for a SAP solution compared with third-party software, which costs are involved and what the next steps are to be taken.


As a SAP QIM/ERP specialist, we provide you with support for SAP-specific design, configuration, production planning and production cutover, both for SAP QIM as well as the quality notifications/integration into SAP ERP.

Our many years of experience with SAP QIM and QM – and particularly with integrating other SAP modules – provide you with expert help for mastering your challenges.
Our implementation work can also include the following services:

  • Conceptual design and programming of role-specific QM apps
  • Conceptual design and programming of interfaces
  • Programming of additional functions
  • Programming of additional data fields
  • Any modifications to forms as required

We specialise in particular in the development of Analytical and Functional Apps.
This makes it much easier for you to deploy deviation management with SAP as part of a digitalisation strategy.

Services & Support

Even after your deviation management process in SAP goes live, we can provide second- and third-level support services as required. Regardless of whether you need remote service provision or direct, on-site support, our SAP specialists offer a mobile and flexible service. Our wealth of experience means we are familiar with the key questions asked by your users and can guarantee prompt support into the long term.


Use our experience as specialists for Deviation Management with SAP:

  • Over 20 years of expertise in the implementation of SAP QM and deviation management
  • Comprehensive experience gained in a wide variety of SAP ERP implementation projects
  • A wealth of pharmaceutical know-how applicable to the handling of deviations and deviation/CAPA management
  • Detailed functional and technical expertise related to SAP QIM and QNs in SAP QM
  • Incorporation of process-oriented and agile rollout strategies (BPMN 2.0, SCRUM, Design Thinking)


Matthias Bothe

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

Matthias Bothe, DHC GmbH
Carsten Buri

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

Carsten Buri, DHC AG
Request information!

Learn more about our consulting services for Deviation Management / CAPA with SAP!


28. Januar
Web session (in German)

Validation of SAP S/4HANA on-premise and Private Cloud Edition

The webinar looks at the validation requirements for SAP S/4HANA on-premise vs. cloud systems.

04. Februar
Web session (in German)

UDI: Implementing global requirements with the right strategy and software

Implementation of the UDI requirements based on the SAP Cloud Platform with the UDI Platform of p36

10. Februar
Web session (in German)

Your journey to the secure Microsoft Cloud for Pharma, Medical Technology and Biotech

Overview of the key success factors for security on the path of regulated companies to the Microsoft Cloud

11. Februar
Web session (in German)

New ISPE GAMP® Good Practice Guide: Enabling Innovation

What does the new ISPE Guide mean for Computer System Validation (CSV) or Computer Software Assurance (CSA)?

18. Februar
Web session (in German)

QM in S/4HANA – Example of an integrated LIMS in a Customer Project

Presentation of the quality-relevant processes of a LIMS in a customer project with the help of SAP QM as an integrated overall solution.

10. März
Web session (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.


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