Battle of the information management systems

Which information management system is better for your laboratory – LIMS or SAP? Robert Pavlis investigates

Can SAP QM replace LIMS in industrial quality control labs? There is no doubt that this is again a hot topic: in the last eight months alone a number of large companies have made the decision to replace their LIMS with SAP QM. Is this a permanent trend or will companies revert back to LIMS once they understand the limitations of SAP QM?

SAP started marketing their QM (Quality Management) module as a LIMS about five years ago and at the time they approached Labtronics to develop an instrument interfacing solution to complete their offering. A number of companies investigated the SAP product, but most concluded that it was not yet a complete enough solution to be used as a LIMS.

SAP has continued development of their product and in the last eight months a number of large and mid size companies have looked at the “new” SAP QM and made the decision to replace their LIMS with SAP QM. Quite a few others are looking into it as an option.

From the company’s perspective, having one system provides some clear benefits: one system is usually less expensive to deploy and manage; integrating the lab into manufacturing throughout the supply chain has many benefits; and company-wide traceability is easier with one system. In today’s tighter economy, I expect that more companies will ‘insist’ that the lab uses SAP, by not funding LIMS projects. From a corporate level this decision makes a lot of sense.

A large Pharma company has asked us to interface their lab instruments directly to SAP QM using the LimsLink product. What made this request surprising was that they also wanted LimsLink to perform some calculations that were clearly better done in SAP since they needed to use some specific SAP values.

The reason for not doing the calculation in SAP was that “it is too difficult to get our SAP development team to add the calculations”. This is a very important message and one I have heard from a number of sources. A very similar comment is “our SAP team does not want to add extra fields to store our metadata”.

My conclusion is that SAP QM can be customised to do most things that a LIMS can do. However, the corporate willpower to make that happen does not always exist. Laboratories seem to have little say in the design of SAP QM during the implementation phase and are simply told which data the company needs. This results in a less than ideal solution. 

You can compare the products all you want, but if the corporate implementation team does not see the lab as a priority then the implemented solution will not be tailored for the lab. But what are the limitations of SAP QM?

Instrument Interfacing
SAP offers the QM-IDI (Inspection Data Interface) for integration. This is an API that is designed to work with another software system like a LIMS to exchange information. It is not suitable for connecting instruments directly to SAP QM. A better option is an interface tool like LimsLink that can connect any instrument to SAP in a ‘black box’ bi-directional mode.

The LimsLink solution works well for sophisticated instruments that have their own data system; for example chromatography and ICP. It does not work as well for manual instruments like balances and pH meters which are better automated with an ELN. 

Manual Procedures
Much of the work in the lab is still manual, even if it involves a simple instrument like a balance or pH meter. Manual processes are also used to capture visual inspection information. Getting this kind of data into SAP QM requires a system to control the user during the workflow, and then to transfer data to  SAP.

An ideal product for this is an ELN specifically designed for a quality lab. Such an ELN can provide standard worksheets for controlling the process and capturing data. The worksheet can retrieve sample information and product test limits from SAP. The analyst then completes their work, and results are automatically reported back to SAP.

Storage of Raw Data and Metadata
SAP QM is typically not configured to accept raw data and metadata from the lab. This may be due more to an implementation decision than a limitation of the product, but nevertheless, it is a problem for the lab.

The best place to store raw data is in an SDMS and several such products are available on the market including Nexxis SDMS, NuGenesis, and OpenLAB. LimsLink will store raw data in these systems automatically at the same time it sends results to SAP. This solution is easy to implement and can be very cost effective.  

The storage of metadata is a more complex problem. The metadata for manual processes should be stored in the ELN worksheets, which are then stored in a searchable SDMS. This data is then easily retrievable when required.  Metadata for larger instruments can be stored in data systems, but this will result in information being all over the lab. When instruments and data systems are upgraded you run the risk of losing this data in files that are no longer supported.

A better solution is to use an advanced instrument integration solution that automatically stores the metadata that is not sent to SAP QM. This data should be stored in a standardised database format.  This type of solution has an added bonus. With the correct metadata stored, you can now get real time analytics on instruments and samples. This allows you to answer questions such as: How many samples were run on instrument ‘A’ last month? Do we need to buy an additional instrument? Which chromatography samples were run on column ’B’?  This is great information for planning lab expansions and performing investigations into possible problems.

Workflow Control
A laboratory manager needs to control the workflow in the lab. For this you need access to other lab tools such as inventory control, instrument calibrations and training records. Some of this functionality is available in SAP QM. For example release 4.0b now supports calibrations. But are these systems implemented for lab use? If not, the lab will require its own system.

As laboratory systems become more sophisticated they will start providing better workflow control for the people and systems in the lab. LIMS can only provide this functionality in a very limited way since the LIMS does not control the users at the bench level. LIMS does not really know what the analyst is doing minute by minute and therefore can’t control workflow. SAP QM has the same problem.

Controlling workflow is something that is required at the bench level, and will need to be solved outside of SAP or LIMS.

In-process Samples
The results for in-process samples are not routinely stored in SAP; but the lab still needs to manage such samples.  A LIMS could be used for this, but when SAP QM is being used for final product results, a LIMS is an overkill for the problem.

An alternative is to use a simple sample management tool that tracks samples and records results. This type of solution can be much less expensive than implementing a full LIMS and it can be part of the lab automation system. So for example it can be part of the ELN or the iLAB system that is used to manage workflow in the lab.

It seems fairly clear that a significant number of larger companies will replace LIMS with SAP QM on a long term basis. Over time we can expect SAP QM to provide more and more LIMS type functionality, but as one analyst said to me: “SAP is not a LIMS”. 

A feature by feature comparison clearly shows that LIMS is a better choice than SAP from the lab’s perspective. However, the decision may not be a lab decision and from a corporate perspective SAP is a suitable alternative, provided steps are taken to solve some of the remaining problems that lab will have. The good news is that the tools required to solve these problems are available today and with proper implementation these tools can overcome the limitations in SAP, making SAP a solid alternative to a LIMS. 

Author: Robert Pavlis is President of Labtronics Inc