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MashFrame ST : Stability Study Management System

Overview

MashFrame ST is a web-based, enterprise-level, collaborative, part 11 compliant and secure pharmaceutical stability software designed to automate and streamline the entire stability program from start to finish. It eliminates the use of multiple software's to manage the stability program by allowing the execution of all stability based functions using an interactive dashboard. It contains four modules namely: Protocol, Data, Review and Report modules. A brief overview of each of the modules is provided below.

Protocol Module
It allows users to establish an electronic stability protocol by capturing various protocol elements, such as study purpose, team, location, packages, batches, conditions, testing frequency, tests, etc. It provides visually enhanced, intuitive interface to create stability schedule. Individual test components and their replicates can also be configured based on study design. Finally, it generates a word or PDF document of the stability protocol for review or distribution.

Data Module
Once the stability protocol is established, users can enter stability results directly in the applications database. Alternatively it can be integrated with other sources like LIMS or Excel to retrieve data. It also provides built in validation checks for data.
Review Module
The versatile state-of-the-art integrated graphing tool provides up-to-date graphs in real-time. User can dynamically pick and choose any combination of test, component, batch and condition to view graphs. It displays the graphs, along with the associated data tables and the summary of results for ease of review. The summary of results provides simple statistics such as maximum and minimum values based on batches and conditions. Modifications made to the graph to suit the needs can be stored and be used to generate reports in the report module.
Report Module
Reports can be generated in this module which are formatted, secure and auditable and available in multiple formats (like Word, PDF, etc.) to meet individual needs.
Additional Features
MashFrame Mobile extensions allows users to access results and view reports via web-enabled mobile devices. It allows the locking of the stability study using mobile devices. It also allows email notification to users on various activities.
In a nutshell, MashFrame ST allows users to manage stability program from one secure, compliant and web-based interface. It is a one-stop-shop for all stability needs.

Protocol Module

Some of the features of MashFrame ST Protocol Module are:

Ability to create an electronic stability protocol.
Elimination of the use of other time consuming word processors to author, review and approve stability protocols.
Provides flexibility to create stability protocols involving the following but not limited to:
 
  • Large or small molecules
  • Drug substances or drug products
  • Various types of studies such as Investigational or Registrational studies
  • Various Formulations
  • Various Packages
Ability to pick and choose conditions, timepoint and tests to create a visually enhanced, intuitive stability schedule, from configurable lists in the database.
Ability to configure the components and replicates for the selected analytical tests for a study.
Allows creation or modification of the study team members by simply choosing assigned users existing in the database.
Provides configurable instruction list for shipping, storage and testing of stability samples.
  Provides ability to define drug substance or drug product batches to be used in the study.
Allows individual project assignments to users, based on roles.
Able to lock, unlock and version control a study.
Eliminates the additional step of programming LIMS to setup the stability protocol.
The stability protocol information can be transferred electronically to other LIMS.
Generates a word or PDF document of the stability protocol for review.
Printing of the stability protocol with a date/time stamp and version number to comply with the cGXP requirements.

 

Data Module

Some of the features of MashFrame ST Data Module are:

Allows users to enter results directly in the applications database.
Allows the integration of MashFrame ST with other data sources like LIMS or Excel to retrieve data.
Provides data entry interface from any location or site, with an Internet connection, streamlining the third-party data entry tasks.
Provides ability to export data in various formats (Excel, XML, etc.).
Provides built in validation checks at the time of manual data entry or during data retrieval from LIMS.
Allows data review and approval of stability results.
Capability to sort, filter and view all results for a study.
Color scheme of the rows provides a visual link to the three stages of data entry
 
  • Future samples
  • Testing ongoing
  • Testing completed and data locked
It also allows notification to be sent out in cases such as, if atypical results are reported, if all data for a particular timepoint are available to be viewed and if the analysis is not completed within a certain time.
 



 

Review Module

Some of the features of MashFrame ST Review module are:

It provides high-quality colored or black/white graphs that can be configured for review or reporting needs.
The graphs are generated dynamically based on the test, component, batch and condition combination chosen.
It allows the monitoring of all ongoing stability studies in real-time with up-to-date plots, stability data and simple statistics.
It displays the graphs, along with the associated data tables and the summary of results for ease of review.
It makes the monitoring of all stability studies very simple.
It allows user to add comments / discussion associated with the graphs which can be generated as part of the reports.
The graphs have several features such as ability to scale axis, add up to four reference lines, zooming-in by selecting the area for better clarity, ability to edit legends, edit axis labels, etc.
Another enhanced feature is the ability to view the graphs in real-time on web-enabled mobile devices.
It is web-based, so it can be accessed from any computer terminal with an Internet connection.
Ability to export graphs to Word or PowerPoint to satisfy individual needs.

 

Reports Module

The report module allows generation of reports to meet individual needs.
The reports can be generated for the graphs that are saved in the review module and all the settings associated with the graph are stored to be part of the report.
The reports can be also viewed on web-enabled mobile devices.

Evaluation

We are pleased to make evaluation copy of MashFrame ST available to you, so that you may evaluate this software within your environment before making a purchase decision.

Click here to register for evaluation copy.
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