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A variety of interactive templates are used within WinLIMS to define testing procedures, product specification, protocols, instruments in order to make workflow as efficient as possible. These templates can change over time so WinLIMS provides a version control and audit trailing system to ensure adherence to CFR 21 Part 11.

Method Templates

Test method templates are used to define the details of the testing methodology including descriptors such as:

  • the test method name
  • the instrument (or type of instrument) used to perform the analysis
  • a cross-reference to it's SOP (Standard Operating Procedure) document
  • the amount of sample required to test
  • the type of storage container and preservative required
  • the sample preparation reagents and steps
  • the test sequence template.

...and the individual parameters (analytes) that are associated with the testing method. Each of the parameters have their own details associated with them. The details of each parameter include:

  • the parameter (analyst) name
  • the unit of measure
  • the decimal precision
  • calculations used to derive the results (when applicable)
  • menu lookup values (when applicable)

Sample Type (Test Suite / Product Specification) Templates

Test Sample Type templates are used to define products (raw materials, finished products, in-process materials), sampling points, general test suites, etc. that are routinely encountered by the laboratory. These can be named and categorized by you to ensure fit.

  • the test methods that should be assigned
  • the conditions of the test assignment (e.g. frequency, sampling points, etc.)
  • confirmation test assignment rules
  • the specification limit(s) for each measured parameter (analyte)
  • the statistical testing rules

Protocol Templates

Protocols are used to create multiple samples in one action. There are basically two types of protocols:

  • Time-Based
  • Job-Based

Time-Based Protocols

Time-based protocols are used to automatically create multiple samples based on on a per-defined set of time and storage (or event) conditions. Upon initiating a study WinLIMS will automatically create samples using a template for proper identification and schedule them accordingly.

During the initiation process, descriptive labels (which can include bar codes) can be automatically produced to affix to the samples to ensure proper identification. Reports can be issued at any time using the assigned information to allow the laboratory to accurately schedule staffing to manage their workload. As samples become due for testing they will automatically appear within pick-up lists to ensure that they are analyzed in a timely manner and are never overlooked.

Time-based protocols are most frequently used to monitor product shelf-life (stability) under a variety of storage, exposure or reaction conditions. This type of protocol is used extensively by Pharmaceutical and food companies to ensure the efficacy and safety of the products that they market.

Pharmaceutical companies also use protocols to perform bioassay studies on animals and patients to the bioavailability [1] of a drug when performing pharmacokinetic studies. Additional information regarding the subjects that are tested are also maintained in order to analyze trends based on user-configurable factors such as age, sex, weight, etc.

All of the samples that are associated with specific protocols share common information. This allows well-structured textual and graphic reports that convert large amounts of data into useful information that can be used to identify trends and provide predictive behavior in a rapid manner.

Job-Based Protocols

Job-based protocols are used to automatically create multiple samples based on a pre-defined testing sequence or pick-up list. Upon identifying the job WinLIMS will automatically create the samples using a template for proper identification. This greatly simplifies the job of creating samples that are routinely run.