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EnglishDEVIATION MANAGEMENT & CAPA
Identify quality deviations and
develop measures to avoid them!
DEVIATION MANAGEMENT AND CAPA WITH SAP QM
In regulated industries such as pharmaceuticals and medical devices, structured deviation management and effective corrective and preventive actions (CAPA) are essential to ensure quality, safety, and compliance. SAP offers a fully integrated solution that enables companies to systematically capture and analyse deviations using modern, easy-to-use mobile applications, and to control targeted actions for troubleshooting and error prevention.
A key advantage of SAP is its integrated process management, which enables seamless integration with other quality processes such as complaint management, audit management and change control. Standardised workflows, automated escalations and electronic approvals ensure that all deviations and corrective actions are efficiently processed and documented – a critical factor for compliance with GxP, FDA 21 CFR Part 11, ISO 9001 and ISO 13485.
For root cause analysis, proven methods such as FMEA, 5-Why or Ishikawa analysis can be used directly in the system.
Corrective and Preventive Actions (CAPAs) can be linked to test plans and inspection lots, enabling companies to be both proactive and reactive. The complete documentation of all process steps ensures that companies always work in an audit- and compliance-compliant manner.
Comprehensive data analysis is another highlight: real-time dashboards and key performance indicators (KPIs) enable continuous monitoring of process quality. Integration with the SAP Analytics Cloud allows companies to generate detailed reports and identify opportunities for improvement.
DHC digitises deviation management and CAPA processes in SAP Quality Issue Management (QIM) or with the help of quality notifications (Q-notifications) in SAP QM. The advantage of both solutions is their full integration into SAP ECC 6.0 or SAP S/4HANA, which helps to avoid redundant data and error-prone interfaces.
DHC CONSULTING SERVICES FOR DEVIATION MANAGEMENT / CAPA WITH SAP
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.
Scoping
Together with your QM experts, the scope and application scenarios of SAP for deviation management and CAPA are determined and a high-level strategy is defined. 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.
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.
WHY CHOOSE DHC?
Leverage our experience as a deviation management specialist with SAP:
- More than 25 years of experience in implementing SAP QM and Deviation Management
- Extensive experience in various SAP ERP implementation projects
- Extensive pharmaceutical know-how that can be applied to handling deviations and deviation/CAPA management
- Detailed functional and technical expertise regarding SAP QIM and QNs in SAP QM
Managing Director & Industry Unit Manager
Life Sciences, Chemie and Medical Engineering
phone: +49 681 93 666 0
email: matthias.bothe@dhc-gmbh.com
CEO and Director Sales & Marketing, DHC Switzerland
phone: +41 44 500 888 7
email: carsten.buri@dhc-ag.ch
Learn more about our consulting services for Deviation Management / CAPA with SAP!
