If we had a nickel for every time someone has asked the eternal question “Which is better, SAP QM or LIMS?” we would all be able to retire in style on the beach in Malibu! It’s a mystery why this question has persisted for so long in the informatics world. Is it because it’s a highly charged, “religious” type issue? Is it a turf war (laboratory vs. manufacturing) issue? Is it because these systems have evolved over time making the landscape blurry? The answer is – a little of each.
So first, let’s take a little history tour. In the beginning, there were paper notebooks and index cards where all technical specifications and testing data, metadata, and results were recorded for raw materials, in process goods, and finished products. And it was good. Then came the ever popular spreadsheets which were eventually (and are still being) replaced by the all-powerful LIMS. And it was better. The lab management was happy. The lab workers were resigned (or happy depending on the usability of the LIMS implementation. But the production staff and quality personnel were dismayed as they had to beg for their results from the lab personnel or the LIMS.
Then came SAP – that which promised all things to all people, if one had enough time, resources, and money. And lo, as SAP spread throughout the organization and then the manufacturing processes, they espied the quality lab on the periphery. And SAP decided that they should handle all that data and information too, and so SAP QM was born. And the laboratory heavens exploded, the lab managers were confused, the lab workers were still resigned, but the production staff and quality personnel were uplifted. They were to be the masters of the lab and all was right in the production world and SAP was king. Amen.
Thus was born the SAP QM vs. LIMS conundrum.
Unfortunately, there is no definitive answer to the question of which is better SAP QM or LIMS. Like most situations when it comes to informatics systems, the choice of the best solution is generally dependent on your needs, requirements, culture, standards, and infrastructure. However, here are some general guidelines that can be applied to help you decide.
|Situation / Requirement||System to Choose|
|Manage the entire lab organization||LIMS|
|Storage of raw data and metadata||LIMS|
|Real time lab processing||LIMS|
|Instrument interfaces (manual and instrument systems)||LIMS (or SAP QM IDI + instrument interfacing tool, kinda)|
|Instrument calibration||LIMS (or SAP QM & PM, kinda)|
|Stability Studies||LIMS (or SAP QM & PM, kinda)|
|Simply record quality test results||SAP QM|
|Supply chain integration is valued||SAP QM|
|Global control of specifications||SAP QM|
|Lot / Batch / Process quality results only||SAP QM|
We have found that the solution companies chose to implement is often one that combines SAP QM and LIMS. This gives the lab a user friendly interface (the LIMS), a place to store raw data and metadata as well as access to all the features and functions a LIMS offers to manage the lab, processes, instruments, inventory, etc. At the same time, the quality and manufacturing personnel get what they need in the SAP QM side. The exception to this is when a large, global organization that has SAP deployed worldwide decides that having two platforms (i.e. LIMS and SAP) is not cost effective and that the features and benefits of a LIMS are not that critical to their manufacturing operation and hence the company. In this situation, SAP QM is deployed and may even displace a currently implemented LIMS.
Now, this is not to say that an integrated solution does not have its share of hiccups. One of the biggest is the question of which is the master system and which is subservient with respect to the specifications, test points, and test scheduling. In some companies, the LIMS will be the penultimate repository of the specifications and testing information and results (i.e., the master) and in others, it will be SAP QM. Either mechanism works. The decision is usually driven by company culture, departmental power (QA lab vs. manufacturing) and politics. The one thing you can count on in these situations is that the decision is rarely an easy one.
– – – – – – – – – – – – – – – – – – – – – – – – – – – – – – – – – – – – – – – – – – – –
Tell us how you chose between implementing SAP QM or LIMS. Did you implement an integrated solution utilizing both? If you did, which system was the master system and which was subservient?
In my experience, it’s always been the situation that Corporate has made the decision to implement QM because all quality data belongs in SAP and the plant lab was not giving up LIMS. Thus, there was a need to bring the two together. Thermo’s SampleManager has a pretty nice interface between the two. Baytek’s WinBLISS system does as well.
Do you think though that with SAP’s S/4HANA and the new UI experience through Fiori applications will change the mind of most LIMS users? I mean, they have enhanced QM so much that all of the shortcomings from SAP QM in the past seems to be met / exceeded now and future enhancements of SAP. In my mind it would be more cost effective to get rid of LIMS because its increasingly expensive to integrate lab equipment as you only get a small amount of licenses to start with, then it only goes up from there.
Duncan thanks for your comments. While HANA and Fiori will definitely help with lab personnel’s satisfaction level with interacting with SAP QM, there are still fundamental issues and concerns from a laboratory operation point of view as to why SAP QM without a LIMS may not satisfy the needs of the lab overall. Also, while some LIMS count instruments as a form of user, not all do so. Besides, interfacing your instruments to whatever data management/repository system that you are using is still a best practice for efficiency, error reduction and quality reasons. So interfacing your instruments to LIMS or SAP should still be pursued and the costs of doing so in either solution are often a wash.
Does anybody or any company use SAP QM module for stability study?
Does it acceptable to Regulatory authorities?(FDA ,MHRA etc)
If you have any information,please share..
Experience of using SAP for stability study is not satisfactory.
It is complicated,interdependent on many functions,department and persons including question on data integrity.
Thanks for your comments. While by no means a standard in the industry, there are companies that utilize SAP QM for supporting Stability Testing. Here is a good article on the topic. I hope this helps: “How to Configure an SAP Stability Study for Better R&D and Product Improvement.”