LIMS VERSUS SAP QM
More and more companies, especially in the pharmaceutical industry, are raising the question whether SAP QM is able to satisfy their requirements in terms of laboratory information management system (LIMS) processes. This question often leads to protracted discussions, which can be costly and time consuming. Many times such debates continue for years without any clear outcome. Why is this question so hard to answer, and why are there such strong differing opinions regarding this topic?
Some years ago, SAP QM was unable to provide typical LIMS functionalities, which made the decision for a LIMS implementation fairly simple. From the beginning of SAP QM’s existence, the best of breed approach was to use SAP QM for quality assurance functions only. The integration into the LIMS was handled via a standardized interface (QM-IDI). A LIMS was used for quality control activities, e.g. for recording results, the interfacing of test equipment, stability studies, and sample management. Many experienced people still believe that SAP QM cannot capture typical LIMS functionalities and prefer the use of a LIMS for all quality control functions.
SAP QM functionalities have been enhanced by typical LIMS functionalities, and there are many success stories available from satisfied customers using SAP QM as a LIMS. The question should not be whether SAP is able to provide these functionalities, but rather: What is the benefit of using SAP QM instead of using a Laboratory Information Management System?
Former best-of-breed approach:
SAP R/3 was originally focused on quality assurance functions. The final usage decision for a product was either handled inside of SAP or automatically transferred from the LIMS to SAP via a standardized interface (QM-IDI). The LIMS is usually interfaced with additional software products to cover all required functions aside from the typical quality control features. Trending and statistical reporting are usually handled inside special trending tools. Scientific Data Management Systems collect raw data from advanced test equipment. Electronic Lab Notebooks cover all the requirements of a physical laboratory notebook and can also be used for reagent management.
Our best-of-breed approach:
Over the years, SAP added more and more typical quality control functions so that SAP ECC 6.0 is now able to cover all typical LIMS features. Interfaces with the trending tool and the ELN/SDMS ensure full coverage of all required functions. The LIMS itself is no longer needed. Electronic Lab Notebooks and SDMS should be highly integrated, and ideally both software products should be from the same provider. In addition to typical SDMS and ELN functions, SAP is able to handle all other requirements.
What is the benefit of using SAP QM instead of using a Laboratory Information Management System?
Many pharmaceutical companies are struggling with the number of computer systems and the related complexity of their system architecture. Also, the FDA often complains about IT infrastructures being too complex with
too many interfaces,
data redundancies, and
- weak overall traceability of data.
That is the reason many pharmaceutical companies are trying to reduce the complexity and the number of computer systems. If there are multiple LIMS platforms installed, SAP ECC 6.0 can be used as an Enterprise LIMS and all other Laboratory Information Management Systems can be replaced.
It is likely that SAP is the lower cost option compared to a LIMS. Usually, the
SAP hardware is already in place,
the system is up and running, and, in some cases, the additional licenses for the laboratory users are already available and paid for.
In this case, the only costs would be the implementation costs, while the LIMS has additional
In conjunction with an ELN/SDMS, SAP QM is able to consolidate LIMS in a regulated pharma environment for QA/QC laboratories.
This recommendation does not apply to R&D laboratories. These laboratories usually have very specific requirements, and the existing LIMS are usually heavily modified. There are more suitable solutions on the market than SAP QM in conjunction with ELN/SDMS in this case.