Stability Schedules Management

Stability Schedule Management and Tracking Software

Stability studies will certify the maintenance of product quality, efficiency, and safety throughout the shelf life or period of time, this can be considered as a pre-requisite for the acceptance and endorsement of any pharmaceutical product. The persistence of stability testing in pharma industry stands to be a key procedural component in the present pharmaceutical development program for a new drug as well as new formulation.

 

AmpleLogic introduces Stability Management and Tracking software solution is specifically designed for pharmaceutical companies and also records all the conditions under which a study is conducted and keeps track of the stability chambers available.

 

AmpleLogic Stability Tracking System provides complete control of stability studies for a variety of industries that includes the creation of a stability protocol with its various notes, required fields, and imported documents. A set of standard reports are delivered through the module for reporting of the stability protocol and its associated results.

 

  • A single strategic platform for all quality control and assurance activities.
  • Leverages industry best practices with both industry and government regulations and also with ISO standards.
  • A distinct console system to comprehensively manage product specifications and control limits.

The system manages the Stability Plan and Testing, enabling customers to define the test parameters for stability studies, as well as sampling time points, package types, and test methods. AmpleLogic Stability Management Software is a fully comply with 21 CFR Part 11 requirements, with a complete audit trail that is easy to read and search. This system is easy enough to check who corrected a typographical error and powerful enough for in-depth auditing by QA/QC. It helps to generate submission ready stability information or data summaries with a single click of a button.

AmpleLogic Stability Module has executed either in phase wise or full version. The implementation process can be done just in 2 Weeks through a 100% validated system with 21 CFR Part 11 Compliant

Product Stability Automation Module Features

  • Stability Schedule Management and Tracking SoftwareStability Schedule Calender
  • Stability Schedule Management and Tracking SoftwareProducts Master and Templates Configuration
  • Stability Tracking SoftwareEmail Alerts, Remainders, and Escalations
  • Stability Schedule ManagementWorkflow-Based Data Entry and Review
  • Stability ManagementGrade wise Stability Protocol Definition
  • Stability Schedules ManagementTimely Audit Trail
  • Stability Schedules ManagementStorage / Batch wise Stability Data Entry
  • Stability Schedule Management Storage / Batch wise Stability Data Entry
  • Stability Schedule Management and Tracking SoftwareIntuitive Reports

Industrial Challenges

  • To check the quality of a drug substance or drug product that varies with time under the influence of a variety of environmental factors like temperature, humidity, light and to establish a re-test period for the drug substance or shelf life for the drug product and recommended storage conditions.
  • Managing the increasing number of batches manually.
  • In the ability to evaluate and discuss stability data to provide a suitable conclusion.
  • Manual stability testing cannot be integrated with OOS/OOT.
  • Manual stability testing sometimes fails to include all stability indicating parameters like related substances, microbial limit test, etc.

AmpleLogic Stability Schedules Management and Tracking Software Features

  • Stability Schedule Calendar helps to keep track of different schedules of the testing with reminders as well as escalations.
  • Details like Stability Protocol Reference Number, Stability Protocol Version, etc. can be maintained.
  • Separate flow for each Stability Protocol, Stability Initiation Protocol, and Incubation forms.
  • Products Master and Templates Configuration can be done.
  • Workflow based data entry, review, email alerts, reminders, and escalations.
  • Grade wise Stability Protocol Definition.
  • Timely Audit Trail and Predefined test modes.
  • Stability data can be entered based on storage condition or batch number.
  • Intuitive reports, test interval reports, schedule reports and graphical representation of analytical results.
  • Stability detailed report, Stability monthly graphical report, schedule-wise testing report, stability protocol report, and stability monthly reports can be generated from the system for reference.

Benefits of Stability Management Solution

  • Better traceability of various stability samples that are stored or pulled or tested.
  • Quicker reports help to analyze the data and make quality decisions for maximum output in earlier decision making.
  • Provides flexible data-driven workflow, that ensures compliance with standard operating procedures, eliminates manual process, error-prone process steps, and reduces the risk of deviations and noncompliance.
  • Effective implementation of Quality Control automation reduces time efforts for drug discovery and development.
  • Integrates seamlessly with different systems including ERP (Enterprise resource planning), Document Management, and Learning Management System.
  • The only software that provides predefined test modes of different Stability Study Standards.
  • Monitoring of quality-relevant instruments can be demonstrated to auditors during audit trial