How Revol LIMS Can Help You Achieve Compliance and Efficiency in Your Stability Testing Process

Introduction

Stability studies are essential for ensuring the quality, safety, and efficacy of pharmaceutical products throughout their shelf life. However, conducting stability studies can be challenging, especially when dealing with multiple batches, environmental conditions, testing protocols, and regulatory requirements. That’s why you need a reliable and robust laboratory information management system (LIMS) to help you manage your stability testing projects.

Revol LIMS is a web-based LIMS that is designed to handle the complex and dynamic needs of stability studies. Revol LIMS can help you streamline your workflows, automate your data collection and analysis, ensure compliance with international standards, and generate comprehensive reports and trends. In this blog post, we will show you how Revol LIMS can support your stability testing projects, such as shelf-life studies, accelerated aging tests, and stress tests.

Configurable Workflow

Revol LIMS allows you to customize your workflow to suit your specific stability study design. You can define the sample life cycle, the testing schedule, the analysis methods, the acceptance criteria, and the reporting format. You can also create automatic transitions, approvals, and e-signatures to ensure data integrity and traceability.

Revol LIMS supports various types of stability studies, such as:

Real-time Stability Studies

These are long-term studies that monitor the stability of drug products under the recommended storage conditions. Revol LIMS can help you schedule the sample withdrawal and analysis at predefined intervals, track the sample status and location, and alert you of any deviations or out-of-specification results.

Accelerated Stability Studies

These are short-term studies that expose the drug products to elevated temperature and humidity to simulate the effects of aging. Revol LIMS can help you calculate the appropriate conditions and durations based on the ICH guidelines, record the environmental parameters, and extrapolate the shelf life using statistical models.

Stress Stability Studies

These are studies that subject the drug products to extreme conditions to evaluate their stability limits and degradation pathways. Revol LIMS can help you set up different stress factors, such as light, heat, oxidation, pH, and mechanical stress, and analyze the resulting changes in physical-chemical, biological, and microbiological properties.

Instrument Integration

Revol LIMS can integrate with various instruments and devices that are used for stability testing, such as balances, pH meters, spectrophotometers, chromatographs, dissolution testers, and environmental chambers. This enables you to capture the data directly from the source without manual intervention or transcription errors.

Revol LIMS can also validate the instrument performance and calibration status before each analysis to ensure accuracy and reliability. You can also configure the instrument settings and parameters from Revol LIMS to ensure consistency and reproducibility.

Inventory Management

Revol LIMS can help you manage your inventory of samples, reagents, standards, and consumables that are involved in stability testing. You can track the quantity, quality, expiry date, storage condition, and usage history of each item. You can also set up alerts and notifications for low stock levels or expired items to avoid delays or disruptions in your testing process.

Revol LIMS can also help you optimize your inventory usage by providing consumption-based reports and forecasts. You can also generate purchase orders and invoices from Revol LIMS to streamline your procurement process.

Compliance Management

Revol LIMS can help you comply with various regulatory requirements and guidelines for stability testing, such as ICH, FDA, WHO, ISO, GLP, GMP, 21 CFR Part 11, CAP, etc. Revol LIMS can help you implement the best practices for data security, audit trail, electronic signature, user authentication, document control, change management, corrective action preventive action (CAPA), training management, etc.

Revol LIMS can also generate compliant reports and certificates for your stability studies in various formats (PDF, Excel, Word) with customizable templates. You can also export your data to other systems or platforms for further analysis or submission.

Trend Analysis

Revol LIMS can help you analyze your stability data using various statistical tools and techniques. You can perform trend analysis to monitor the changes in product quality over time and identify any significant deviations or anomalies. You can also perform shelf life estimation to predict the expiration date of your product based on accelerated or real-time data.

Revol LIMS can also help you visualize your data using various charts and graphs (line chart, bar chart, pie chart, histogram, box plot, scatter plot, etc.). You can also create dashboards and widgets to display key performance indicators (KPIs) and metrics for your stability studies.