Stability studies determine how a component or product degrades over time, what impurities appear, and how storage conditions impact this process. SciCord Stability Manager includes the tools to define, execute, and report laboratory Stability studies.

SciCord believes that creating and maintaining better software solutions for laboratories will equate to better science – research and development, analytical testing, manufacturing – and increased innovation during a time when the public demands it. SciCord Stability Manager is an intuitive solution optimized for quick setup and management of simple stability studies while including the tools and functionality necessary to manage the complexity of larger studies. Stability manager streamlines data processing for the analyst while providing efficient reporting mechanisms to simplify the presentation of finalized data for internal use or regulatory submission.

SciCord Stability Manager is an off-the-shelf product utilizing cloud technology to provide a scalable tool that is affordable for businesses of all sizes. Installation, validation, training, and support are provided by a SciCord Team, including project manager, template developer, validation expert, and SciCord support staff. The SciCord Stability Manager follows 21 CFR Part 11 compliant guidelines and has been fully validated per the FDA and GAMP5 criteria.

SciCord’s Stability Management supports:

Creation and Modification of Study Protocol

  • Simple to use editor with flexible protocol setup and modification
  • Easy-to-use time interval and storage condition selection process via drop-lists
  • Assign multiple storage dates for varying storage conditions within a single study.
  • Automatic calculations, including units needed and scheduled dates
  • Adhoc testing and study revision

Electronic data entry, reviews and approvals

  • Data goes through entry, review, and approval statuses
  • Data can be exported directly from SciCord to Microsoft Word or Excel file formats
  • SciCord is capable of integrating with third party software for either data import or export

Work Requests, Calendar Functionality, Messaging/E-mail Notifications

  • Work Requests can be assigned a specified date/time frame and tester, among other items
  • Create testing schedules and visualize testing forecasts and late work
  • Receive Messaging/E-mail notifications for work requests
  • Supports multi-laboratory testing
  • Filter workload by date, tester, location
  • Export Calendars to Outlook

Statistical Analysis and Formatted Reporting

  • SciCord provides a Stability Datamart to support analytics using any SQL compatible visualization tool (JMP, Spotfire, Power BI …)
  • Out-of-the-box Reporting includes:
    • Data from multiple tests compiled into a comprehensive stability report
    • Charts are dynamically adjusted to display specific results and conditions
    • Regressions are automatically calculated to provide estimates of when the product will fall out of spec
  • Like all SciCord products, existing Stability reports can be tailored to your organization’s needs, or new features can be added upon request