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:
- Pharmaceuticals, OTC Products, & Registration Batches
- Foods & Beverages
- Healthcare Products & Medical Devices
- Dietary Supplements
- Paints & Coatings
- Cosmetics & Cosmeceuticals
- Sunscreens & Topical Products
- Other Commercial Products (anything with an expiration date)
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:
- Defining static data used for building study designs, such as study conditions, time and layer factors. Static data in stability module is set using “VGL style” forms.
- Creating study design templates, known as protocols
- Creating specific study designs
- Managing studies
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:
- Integration with SampleManager lots functionality – SM11 centralizes lot-related functionality on a single entity that can be associated with different stability studies (as needed). Lots of finished products that are associated with stability studies can be logged in with .NET forms and new SM11 lot entity templates/workflows.
- Articles – A new entity that defines the drug/product that you are testing. Allows the user to enter detailed information about the product.
- Packaging Systems – You can define different packaging systems on same product (article). This allows you to run a specific protocol, or different study designs (Protocol/Study Template), with lots of different packaged products.
- Study Markets – Allows you to define different markets (e.g., countries) with different specifications in study design. You can then check study results against study markets defined in the study design/protocol without needing to create different products (MLPs) and/or study templates in the system.
- Picklists for dispensing – Organizes the “samples to be dispensed” task list for samples on a daily basis. Also automates the dispensing process where the user will confirm the samples being dispensed with the amounts, person and date/time dispensed.
- Improved mechanism for tracking samples – Creates pull events, email notifications, sub-studies on the study design to help manage complex study types (e.g., degradation studies, studies that involve changing the physical location of your drugs within the inventory chambers, etc.).
- Enhanced inventory tracking – Tools to relocate and reconcile inventory on the lot and study levels are available out of the box to handle the different use cases scenarios that may exist. Lot inventory can happen even before stability studies are started. Study inventory allows automatic allocations based on the dispensing of samples (picklists) and manual allocations.
- Forms and Report Designer – Dashboards and reports.
- Graph capabilities – Many additional features and more user friendly than SM2004.
- Validation rules – Configurable rules that ensure study build compliance.
Flexible workflows in the SM11 stability module allow tracking of the following types of stability studies:
- Experimental, R&D or follow-up studies
- ICH short or long-term studies
- Reduced stability testing (ICH Q1D) – gives the user flexibility as to when to pull samples
- Cycling (mimics situations where drugs encounter many different conditions) & Freeze/Thaw Studies (mimics when drugs encounter freeze/thaw conditions) – much more convenient in SM11 because of study cell pull events.
- Different branches of the same study to test degradation of drug sample in more complex scenarios that involve many different conditions – much more convenient in SM11 due to ability to create sub-studies. This allows companies to run a single stability study that covers many different scenarios.
There are a number of benefits that can be realized by upgrading to SM11 stability module. These include:
- Less customization needed. Highly configurable, resulting in reduced roll out and validation costs and overall maintenance of the application.
- Increase operational efficiencies.
- Intuitive user interface decreases training overhead and increases user acceptance
- Flexibility to continue to use the SM2004 R2 Stability Module alongside the new Stability module – this will avoid migrating current on-going stability studies to the new module data/business process structure.
- Utilize the Stability Dashboard to manage everyday activities.
- Utilize enhanced study inventory and sample pull management capabilities.
- Leverage preconfigured stability reports (study details, study reports, study graph).
- Usage analysis and update tools allow you to determine where static data (e.g., Article, Product, Test Group, etc.) is being used and update records as needed. This will address the most complex scenarios and requirements to track different versions of the static data being used by the stability studies.
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.