Stability

Reliably manage your stability programs, reducing errors, and providing a toolset for effective stability testing, analysis, and reporting.

Balancing Lab Efficiency with IT and Compliance Requirements

Do you use spreadsheets or paper to manage your stability program and is that process stretched too far?
Help your teams automate and effectively manage your stability program with automation fit for purpose.

Compliance with Regulatory Requirements

Built in compliance for generating and managing stability protocols, testing schedules, and reports necessary for regulatory submissions.

Improved Data Accuracy

The software reduces the potential for human error in data recording and calculations. This ensures that stability data is accurate and reliable, which is critical for making informed decisions about product shelf life and quality.

Efficient Data Management

Streamline data entry, retrieval, and storage. Support quick access to historical data. Facilitate trending and highlight potential issues.

Automated Scheduling

Automatically generate stability inventory requests, testing schedules and sample pulls based on predefined protocols. This reduces the administrative burden on laboratory personnel and minimizes the risk of missing testing deadlines.

Alert and Notifications

Receive automated alerts and notifications for detected exceptions. Real time alerts save time and may save a run.

Trend Analysis

Generate trend analysis and shelf life reports through the life of a study to identify stability-related issues or deviations. This allows companies to take proactive measures to address potential problems before they escalate.

Resource Optimization

Automate stability testing processes to increase efficiency, reduce manual paperwork, optimize resources (personnel and equipment).

Reduced Costs

Efficient stability management can lead to cost savings by minimizing the need for retesting, preventing product recalls, and reducing the risk of non-compliance fines and penalties.

Faster Decision Making

With real-time access to stability data and trend analysis, decision-makers can quickly assess the stability of products and make informed decisions about product release, labeling updates, or reformulation.

Risk Mitigation

By closely monitoring the stability of drug products, pharmaceutical companies can identify potential risks to product quality and safety. This enables proactive risk mitigation strategies, such as reformulation or packaging changes, to be implemented if necessary.

If you want a more technical discussion about stability in general, we have a white paper – Read More

Pharmaceutical stability management software is designed to help pharmaceutical companies monitor, manage, and maintain the stability of their drug products. It offers a range of features to ensure compliance with regulatory requirements and the quality and safety of pharmaceutical products. Here are some common features of pharmaceutical stability management software:

Stability Study Management

Study creation: Defines the study protocol including definition of storage conditions, timepoints, required or conditional testing, test groups, inventory sets and pulls, test schedules, and acceptance criteria.
Sample management: Tracks and manages the storage, labeling, and distribution of stability samples.
Test planning: Schedule stability tests and retests based on predefined protocols. Work request system for calendar view or email notifications.
Data Entry and Recording: Assures accurate formats, lists entries, precision, and verified against specification criteria.
Libraries: Define generic study types as libraries to quickly and reproducibly create new studies.

Specifications

An important part of setting up a stability study is assigning a specification. These specifications do the following:

Define the required testing for a product or formulation
Define warning limits and acceptance criteria for textual or numeric results
Specify the precision of numeric result OR specify the allowed values for textual results
Secure workflow for reviews and approvals.

Test Processes

Record your test information directly in Templated test documents to eliminate paper from your stability processes.
Includes proforma sample & standard preparation, automated calculations, instrument interface, references to materials and equipment with full audit trail and electronic signature.
Secure workflow for reviews and approvals.

Reporting

Trend analysis reports to monitor stability data over time, helping identify potential issues or deviations.
Statistical tools for analyzing stability data and calculating shelf-life estimates.
Stability reports compliant with regulatory standards, such as ICH guidelines.

Dashboard

Visual display for real-time monitoring of stability studies, including status, test completion, and deviations.
Automated alerts and notifications for scheduled inventory transaction, scheduled tests, deviations, and out-of-specification results

Sample Management

Comprehensive stability sample management including: location tracking, chain of custody, barcode scanning, inventory transaction scheduling an logs, and sample workflow with electronic signatures to capture status change.

Document Repository

Store and manage stability study-related documents, including protocols, reports, and certificates of analysis.
Maintain version control for documents and ensures that the latest versions are used in stability studies.

Documents are linked together by an index document, and can be retrieved at any time

Integration with Laboratory Instruments

Instrument connectivity: Integrates with laboratory instruments for automated data capture, reducing manual data entry errors.
Data import/export: Allows for seamless data import and export with various file formats and systems.

User Access and Security

Role-based access control: Provides role-based permissions to control access to different system functions and data.

Sequence Visualization

A browser based sequence viewer eliminates the need for reviewers, approvers and decision makers to access & navigate the chromatography system.

A simple, demo version of SciCord’s SciChrom Viewer is accessible below. A guide is also available if you need more information about how SciChrom Viewer works.
Quick Guide

Zoom/Pan Controls

The chart can be panned by left-clicking and holding anywhere in the chart and moving the mouse.
The chart can be zoomed by scrolling up or down on the scrollwheel, or by using a pinch to zoom gesture on touchscreens.
Ctrl-Clicking and dragging the mouse (or clicking down on the scrollwheel/middle mouse button and dragging) will create a zoom-box that will define the new pan and zoom of the chart.
- If the zoom-box does not match the aspect-ratio of the original chart, the injection lines will be vertically stretched to fill the space. This can be used to enlarge small peaks.

Ctrl-Click or Middle-Mouse click to use the zoom-box

Options Panel

The options panel can be accessed by moving the mouse over the gear icon in the top right corner of the chart, or by right-clicking anywhere in the chart.

Reset Chart: redraws the chart from scratch, restores zoom and panning to default positions
Reset Focus: Resets the vertical scaling if the chart has been vertically stretched
Hide/Show Crosshairs: Hides or shows the crosshairs, button label changes contextually
Show/Hide Retention Time: Shows or hides the retention times on peak labels. The button label changes contextually
Configure Columns: Shows a popup dialog that allows you to select the visible columns in the peak table and set number of decimals
Screenshot: launches the screenshot dialog
Hide/Show All: Hides/Shows all secondary injections. Button label changes contextually.
Stacked/Normal View: Toggles the Stacked view on and off. Button label changes contextually.
- If the button is grey and says “Normal View”, secondary injections will be drawn on top of the main injection
- If the button is blue and says “Stacked View”, the secondary injections are given an offset to separate them out from the main injection and each other
  - Four arrows are available below the button to change this offset by moving the secondary injections up, down, left, or right.

ChromView options panel

Legend

If there are one or more secondary injections, an additional column will be added to the legend called “Main”.

The circle icon to the left of the name of each secondary injection will be a colored check-mark. Clicking this icon will turn it into a grey X and hide the corresponding injection in the chart. All of the secondary injections can also be hidden/shown at once using the Hide/Show All button in the options panel.
The circle icon to the right of the name of each secondary injection will be a grey X. Clicking this icon will turn it into a red check-mark and will display the baselines on the corresponding injection.
The main injection will have a blue circle in the “Main” column, while the secondary injections will have a grey X. Clicking one of the grey Xs will make the corresponding injection the main injection and re-order the chart accordingly.

The legend can be moved around the chart by clicking and dragging it.

ChromView legend

Peak Information

Clicking on a peak will highlight the peak in the chart.
- A mini-table will also appear with relevant information about the peak.
The full table is located below the chart. Each row corresponds to a peak.
- Clicking a row will also highlight the peak in the chart.
- The visible columns can be configured in the options panel.

ChromView click peak

For a deeper dive into using SciChrom Viewer, the full user guide can be downloaded:
Full User Guide

If you want a more technical discussion about stability in general, you can read more here.

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