Stability Schedule Management and Tracking Software
Stability studies checks and confirms that product quality, efficiency, and safety throughout a span of time is maintained and according to regulatory standards. This process is considered relevant and serves as a pre-requisite for the acceptance and endorsement of any pharmaceutical product. Pharmaceutical industries incessantly persist on the stability testing of their products to ensure that they conform to set procedures and standards. Stability Management Module in AmpleLogic is a complete software to meet the requirements in biotech, life sciences, pharmaceutical stability testing programs and stability management
For this purpose, AmpleLogic introduces Stability Management and Tracking software solution is specifically designed for pharmaceutical companies, biotechnology, and life sciences industries for stability testing. It also records all the conditions and procedures under which a study is carried out and keeps track of the stability chambers available
AmpleLogic Stability Tracking System provides complete and efficient control of stability studies and testing for a variety of life sciences industries. These studies include but not limited to the creation of a stability protocol with its various notes, required fields, and imported documents. It involves the submission of a set of standard reports, delivered through the module for reporting of the stability protocol and its associated results.
- Acts as a single strategic platform for all quality control and assurance activities.
- It aids in determining the industries best practices with that of the governments’ and other regulatory rules and guidelines.
- It plays a distinct console system to comprehensively manage product specifications and control limits.
The system manages the Stability Plan and Testing and gives customers the responsibility of defining the test parameters for stability studies, as well as sampling time points, package types, and test methods. AmpleLogic Pharmaceutical Stability Management Software fully complies with 21 CFR Part 11 requirements, EU Annex 11, MHRA, GMP and has a complete audit trail that is easy to read and search. The system also proofreads by itself and checks for typographical error and ensure that the data are powerful enough for in-depth auditing by QA/QC. Just a single click can help reveal stability information or data summaries.
AmpleLogic Stability Management Module is designed to be in phases or the full version depending on the user’s choice. The 100% validated system enables implementation to be carried out as early as just 2 weeks and made in utter compliance with 21 CFR Part 11 rules.
Product Stability Automation Module Features
- Stability Schedule Calendar
- Products Master and Templates Configuration
- Email Alerts, Remainders, and Escalations
- Workflow-Based Data Entry and Review
- Grade wise Stability Protocol Definition
- Timely Audit Trail
- Storage / Batch wise Stability Data Entry
- Storage / Batch wise Stability Data Entry
- Contains intuitive Reports
- Checking 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.
- It is a herculean task managing batches manually especially giving the fact that they are always on the rise.
- It is challenging drawing conclusions and final discussions from a list of data prepared manually and it is also tasking to maintain data stability.
- Manual stability testing cannot be integrated with OOS/OOT. Hence. It does not allow for proper integration.
- Parameters that indicate stability like related substances, microbial limit test, etc are sometimes excluded from manual stability testing and this makes the testing inefficient.
AmpleLogic Stability Schedules Management and Tracking Software Features
- Fully compliant with 21 CFR Part 11, EU Annex 11, GMP, MHRA and other regulatory standards
- Stability Schedule Calendar helps to monitor and record the different schedules of the testing with reminders and records of changes made.
- There is a feature for maintenance of details like Stability Protocol Reference Number, Lot Numbers, Sample Size, Manufacturing and Expiration dates, Stability Protocol Version, Test Intervals, Specifications, Storage Conditions and Inventory Management etc
- Separate flow have been created for different criteria such as Stability Protocol, Stability Initiation Protocol, and Incubation forms.
- Products Master and Templates Configuration can be done on the system.
- This Stability Management Software helps analyst to record sample details when it is received such as Product, Strength, Storage Conditions, Charged On Date, Pull Out Periods and Expiration Date
- Accommodation of workflow based data entry, review, email alerts, reminders, and escalations.
- If the analysis result exceeds the defined limit range then OOS/OOT will be triggered by the system
- Stability Protocol Definition are arranged grade wise.
- Adopts Timely Audit Trail and Predefined test modes.
- Stability data can be entered easily based on storage condition or batch number.
- Stability Sample Management Software has feature to send alerts on Out of Trend (OOT) and Out of Specification (OOS)
- All stability samples and their environmental conditions as well
as specific locations (lab, room, incubator, shelf life, etc.) are
automatically tracked by the system
- AmpleLogic Stability Management Solution can generate customized reports such as Intuitive reports, test interval reports, schedule reports can also be represented graphically for better analysis, discussions and conclusions.
- Reports like Stability detailed report, Stability monthly graphical report, schedule-wise testing report, stability protocol report, and stability monthly reports can be generated easily from the system for reference.
Benefits of Stability Management Solution
- Stability samples are better organized and easily traced from the stores or test compartments
- There is quicker reports and analysis. This helps to analyze the data and make accurate discussions, conclusions and decisions for maximum output and productivity.
- AmpleLogic Pharma Stability Management Software System provides flexible and data-driven workflow. This is designed in a way that it complies with standard operating procedures, eliminates manual process, error-prone process steps, and reduces the risk of deviations and noncompliance.
- The Stability Study Management system ensures effective implementation of Quality Control automation which saves time and efforts for drug discovery and development.
- It can integrate effortlessly with other systems including ERP (Enterprise resource planning), Document Management, and Learning Management System.
- It is known to be the only stability testing software that provides predefined test modes of different Stability Study Standards.
- Allows monitoring of quality-relevant instruments which can be demonstrated to auditors during audit trial.
- Having all calculations in a single platform improves efficiency, productivity, reduces risk and provides a significant time savings.
- Ensure all stability sample pulls are performed on time