Posted on LIMS Implementation. 23 October, 2017
The SampleManager LIMS Version 11 provides a crucial capability for drug discovery in its Stability Module. Many people take it for granted that commercial products they use will perform their advertised function effectively. Medical patients, for example, assume that the pharmaceutical drug products they consume will perform the therapeutic activity for which they were designed. Additionally, medical doctors expect that the medications that they prescribe for their patients are safe and effective. The confidence in both these cases is based on the understanding that pharmaceutical companies test their medications extensively prior to releasing them to the public.
One of the most important tests that companies perform to guarantee the safety and efficacy of their products is stability testing. Stability is the extent to which a product retains its properties, characteristics and stated action throughout its period of storage and use. Several regulated industries require stability testing for their products:
In large companies, numerous stability studies with hundreds or even thousands of samples may be ongoing at any given time. It is nearly impossible to manage this effectively with paper-based tracking methods, non-standardized processes, and disparate information systems spread across the enterprise. A quality laboratory informatics system with a dedicated stability module that is integrated across the enterprise can manage many different stability studies automatically. Such a platform creates an integrated laboratory ecosystem through which expiration dates and product safety can be assured.
Thermo Fisher Scientific’s SampleManager LIMS™ (SM) has had a dedicated stability module integrated into its software since 2004, long before most other platforms. Thermo significantly upgraded the functionality of the stability module in SampleManager version 11 (SM11). In this blog, we will give a brief overview of the SM2004 stability module, and then detail the most significant feature upgrades in the SM11 stability module.
SampleManager 2004 R2 Stability Module Overview
SM2004 R2 LIMS is a very robust SM version. SM2004 R2 was one of the first LIMS to incorporate support for stability study workflows. The SM2004 VGL Stability Module allows users to design stability studies that utilize automated sample scheduling. When using the system, there are four main stages:
Stability studies are organized into a matrix where different lots or batches are categorized by:
Storage conditions (C-Factors) – Storage conditions such as temperature, humidity, lighting etc. are defined and identified in the study matrix.
Time Factors – Time factor intervals are set to determine when pulls (planned samples) should be taken from the stored material for testing. It’s possible to add a time zero pull for a layer (batch/lot).
Matrix Layer Factors – Tracks parameters related to product batches other than time factors and storage conditions – batches, different orientations, different concentrations, etc.
This matrix configuration allows tracking of any combination of Batch/Storage Condition/Pull Time inside the matrix.
The sample login time (time a sample is pulled for testing) is calculated based on the study activation date plus the time factor interval. Once a sample is pulled for testing, the sample labels are printed automatically using VGL printer commands or Infomaker (an end-user form, report, analysis, charts and graphs creation tool).
The graphs created by this module are very simple and do not allow much configuration.
This module also has Inventory related features that allow you to track and manage stocks of material. You can see how much of each type of material you currently hold, how much has been allocated for specific purposes (such as stability studies), and how much unallocated material is currently available.
New Features in SampleManager Version 11
SM11 offers a complete re-design of the SM2004 VGL version of the stability module, utilizing .NET technology/tools. This .Net stability module uses a completely different database structure and is incompatible with the SM2004 VGL stability module. However, the two modules can be run in parallel if necessary.
This new .NET stability module in SM11 brings many of new features to the table that allow for convenient tracking of much more complex stability studies that mimic real life scenarios for products.
New Features include:
Flexible workflows in the SM11 stability module allow tracking of the following types of stability studies:
There are a number of benefits that can be realized by upgrading to SM11 stability module. These include:
Monitoring the effects of environmental conditions on the quality of a finished product via a stability study is a critical factor in ascertaining whether a product is safe for consumers. While the SM2004 stability module permits tracking and management of basic stability studies, the SM11 stability module has a wide array of new features providing the advanced capabilities needed to better emulate real-world conditions. SM11 stability module allows companies to undertake and track stability studies in a highly efficient and scalable manner.
Additionally, upgrading to SM11 allows companies to leverage the additional SM functionality (e.g., Workflows, Report Designer, Forms, Label Designer, Stock Management, Lot Inventory and the enhanced Explorer) found in SM11 that can dramatically improve laboratory compliance, operational efficiency, quality, productivity and innovation, while at the same time reducing costs. Astrix Technology Group is a leading provider of services for SampleManager including implementation, upgrades, customization and training.
About the Author
|Andre Schalch is a Managing Services Engineer for the Astrix Professional Services Group where he leads a team focused on SampleManager LIMS implementations. He has over 15 years of hands-on experience with implementations of LIMS, CDS, SDMS and ELN systems for different types of industries (environmental, pharmaceutical, petrochemical, mining, etc..), mostly focused on products from ThermoFisher Scientific (SampleManager and Nautilus LIMS).|
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