Integrated LIMS with SAP

QM with SAP can be used as a complete, fully integrated Laboratory Information Management System (LIMS) for the digital management and control of all laboratory-related processes, ensuring both the administrative functions of an analytical laboratory and the sample cycle or test routine of a sample. Another strength of the LIMS is the ability to automate laboratory processes to a high degree through instrument integration. Through direct integration with SAP ECC or S/4HANA, companies benefit from seamless integration with materials management, production or sales processes, avoiding data islands and ensuring a consistent database. This enables end-to-end traceability and improves the efficiency of sample management, analysis and documentation.
With SAP as the LIMS, test plans can be centrally managed and test batches automatically generated, standardising and automating laboratory processes. Digital recording and management of test results reduces sources of error and improves data quality. In addition, SAP offers powerful analytical tools that provide real-time insight into laboratory results, helping companies to identify trends and make informed decisions.

Another benefit is support for regulatory requirements, as SAP ensures compliance with standards such as ISO 17025, FDA 21 CFR Part 11 or GxP. System logging of test processes ensures complete documentation and audit compliance. Thanks to modern technologies such as IoT integration, machine learning and cloud applications, SAP as a LIMS is a future-proof solution that supports laboratories in their digital transformation and enables efficient, transparent and compliant laboratory work.

The following quality-relevant processes are represented in the system:

Quality planning
Sample management
Inspection processing
Deviation management/CAPA
Quality costs
Certificate creation
Stability tests
Vendor release

Consulting

Business Case
When is IT support for laboratory processes appropriate – and what does this mean for my regulatory requirements? Why is SAP QM the right solution for my company? There are many important questions that need to be answered in order to evaluate the pros and cons of a LIMS. We will work with you to define your objectives, describe the expected potential, assess the risks and calculate the project budget.

Scoping
Together we identify the potential areas of application for your LIMS and plan all the project steps necessary for a successful implementation. This phase includes an assessment of your skills requirements and the internal and external resources needed for the project. We provide you with a timetable for the project steps and an estimate of the expected costs.

Proof of Concept (PoC)
What functionality will be cost effective? And what level of automation is appropriate for what type of laboratory? We look at your laboratory processes in the supply chain and the associated requirements. We then compare these with the functionality offered by SAP QM and present the results as a decision document for your management team. Ultimately, the future LIMS must support you in planning and performing tests in a time- and resource-optimised manner, as well as in collecting, analysing and managing your sample data – all in compliance with regulatory requirements (FDA, GxP, ISO, etc.).

Implementation

As SAP QM specialists, we can also support you with the design, configuration, production planning and production cutover of a LIMS-focused SAP QM solution.

Our implementation work can also include the following services

Design and programming of role-specific QM applications
Interface design and programming
Programming of additional functions
Programming additional data fields
Any necessary modifications to forms

We specialise in the development of analytical and functional applications.
This makes it much easier for you to use your LIMS as part of a digitalisation strategy.

Services and Support

Even after your SAP QM system has gone live, we can provide you with second and third level support services as required. Whether you require remote service delivery or direct on-site support, our SAP QM specialists provide a mobile and flexible service. Our wealth of experience means we understand the key issues your users face and can provide timely support over the long term.

A key success factor is to ensure that the entire value chain is considered during design and implementation, as well as for subsequent services. We therefore ensure that processes are at the heart of our approach and analyse LIMS requirements from a process perspective.

Based on our experience from many projects, we offer best practice models for quality control and assurance to ensure a successful rollout for our customers.

To maximise the benefits of integrating the LIMS with the ERP system, we also take into account the different roles involved in quality control and quality assurance, and develop practical KPI systems and dashboards based on the available SAP data.

During the implementation of your LIMS, we take great care to ensure compliance with regulatory requirements and combine project and validation methodologies.

Use our experience as specialists for LIMS with SAP:

Over 25 years of experience in implementing quality management with SAP and designing QM, QC and QA processes
Best practices, templates and predefined requirements for SAP LIMS
Specialist in industries such as pharmaceuticals, medical devices, chemicals, biotechnology – and more
Extensive expertise in regulatory requirements

Germany

Matthias Bothe

Managing Director & Industry Unit Manager
Life Sciences, Chemie and Medical Engineering
phone: +49 681 93 666 0
email: matthias.bothe@dhc-gmbh.com