What is LIMZ-RD?
LIMZ-RD is specifically desiged for Pharmaceutials, API's and Chemicals development Laboratories.
- LIMZ-RD is tailored for R&D companies involved in new drug development, focusing on activities like:
- Formulation Development
- API Characterization
- Material Compatibility Studies
- Stability Studies of APIs and Formulations
- Method Validation
- Dissolution Profiling
- Impurity Profiling (customizable to client needs)
- LIMZ RD offers high flexibility and configurability, enhancing workflow efficiency, throughput, and data reliability.
- It simplifies administration, sample traceability, and regulatory compliance in R&D settings.
- LIMZ RD can generate comprehensive quality documentation from integrated modules to support regulatory submissions and maintenance.
- It is a valuable tool for research organizations assisting pharmaceutical companies in patent preparation and commercial manufacturing.
- LIMZ RD can be customized to automate contract research studies in areas of AD (Analytical Development) and FD (Formulation Development).
- It adheres to GLP (Good Laboratory Practices) regulations and US FDA 21 CFR Part - 11 guidelines.
Some Salient Features of LIMZ-RD
OasisLIMS offers a comprehensive feature set for establishing project initiation and defining the scope of work, along with specifying timelines, standard operating procedures (SOPs), protocols, and method requirements. The system meticulously records all project-related data at various stages of its life cycle, encompassing multiple levels of processes. There is a distinct option dedicated to capturing introductory details and innovator-specific information about the project. This section contains essential data concerning the project's objectives, scope, planning, and its inherent characteristics. Furthermore, OasisLIMS enables the input of diverse project attributes, outlines, overviews, information sources, and references.
- Product / Client / Test master
- Defining a set of tests
- Performing these tests on a sample
- Generating reports for:
- Product/Material master
- Client master
- Test master
- Specifications - Product - test - test method links
- Establishing a connection between the product
- Linking the product to its tests
- Identifying the necessary test methods
- Ensuring the tests can be conducted using these methods
- Limits
- Categorizing various limit types
- Establishing trend values
- Determining tolerance levels
- Segmenting by product for testing purposes
- Formulations
- Archiving and storing capability for past formulations
- Ability to retain and save historical versions
- Archival function for storing previous formulations
- Storage feature for preserving all prior formulations
- Data Retrieval
- Simplifies the process of collecting data for new product submissions or patents.
- Enhanced Formulation Management and Search
- Accelerates the process of creating new products while minimizing redundancy.
Transaction processing
Sample Management modules enable users to efficiently handle and manage received samples with effectiveness.
- Sample registration and login
- Automated batch sample registration for received samples.
- Support for sample identification and selection through the use of barcodes.
- The system generates distinctive, customizable sequential numbers to track various sample categories.
- Workflow management
- Test allocation to analysts is done on an individual basis.
- The workflow process typically includes the following steps:
- Registration of a sample.
- Supervisor assigns samples or batches to an analyst.
- Analyst conducts tests and records observations.
- Results are calculated.
- The sample is submitted for review and decision-making.
- Concise and comprehensive protocol detailing all the tests to be conducted on a sample in accordance with the specified criteria for documenting test observations.
Reports
The analyst may document observations from the samples and input the results online.
- Selection of tests for entry of readings / observations
- Input only readings and observations
- Results automatically calculated using built-in formulas
- No need for external formulas for calculations
- Online trending with tolerance values
- Detecting trends that are no longer current during data entry
- Conducting operational and validity checks at various levels to prevent incorrect data input
- Sample Review
- Test results can undergo a review and approval process by peers.
- Alternatively, peers may decide to send the sample for retesting depending on the results.
- Result Approval
- Results automatically cross-checked against acceptance criteria
- Automatic determination of sample conformance or non-conformance
- Inclusion of opinions in the Result Approval Report, referencing rejection parameters if needed
- Approved sample results can be exported to various industry-standard formats (Excel, PDF, HTML, RTF, TEXT, etc.) for analysis and reporting.
- Sending a sample to an external laboratory is necessary when there is a breakdown of equipment during analysis, a shortage of essential materials, or the need for validation, among other reasons.
- Reports: Sample status reports, Laboratory data, QC productivity report, Analyst performance report
- Recipe Management and Dynamic Production Formula
- Supports dynamic production formula management
- Integrates with quality control through LIMS interfaces
- Enhances material management and approval
- Stocks Inventory Management
- Manages all aspects of inventory
- Includes features like GRN entry and stock status review
- Provides summary of trial details and material issues
- Offers various reports such as GRN/Stock register and issue register
- Quality Control Integration
- Interfaces with basic LIMS for better material management
- Ensures better control of materials and approvals
- Production Batch Summary - Offers a summary of production batches
- Material Bin Card - Keeps track of material usage
- Direct Consumption Register - Records direct material consumption
- Total Inventory Activities - Covers all aspects of inventory management
- Recipe Management and Dynamic Production Formula
Plug-in-Add-on Modules
Dissolution Profiles
The Dissolution Profile Module serves as a valuable tool for assessing dissolution profiles of samples by conducting comprehensive data analysis. This includes the ability to log in, employ various media and apparatus, adjust speed and time intervals, generate protocol sheets, record observation entries, calculate correction factors, and generate analysis results and data sheets. Additionally, this module enables users to compare and scrutinize two dissolution profiles, making it a highly advantageous resource for computing the similarity factor, a statistical measure for evaluating the likeness between two dissolution profiles. This information can be presented both graphically and numerically.
Integrated Stability Scheduling and Studies
The Stability Module facilitates the organization of analyses at different time intervals under various experimental conditions, such as temperature and humidity, while focusing on specific parameters. It encompasses functions like stability sample logging, scheduling stability tests, recording observation entries, conducting real-time result calculations, and ultimately, certification and reporting.
The outcomes of the stability study can be collectively visualized on a protocol data sheet, offering the choice to present information regarding different environmental conditions and time intervals both in text and graphical formats. Additionally, there is a feature to log stability samples by specifying rack and chamber numbers. The module also provides the capability to generate graphs for stability data and offers a stock report for each walk-in chamber. Users can maintain records of stability sample stocks, including consumption data. Furthermore, there's an option to print stability sample bin cards, and any pending tasks related to stability studies are conveniently highlighted in the alerts and reminders screen.
Stability Trend analysis
Trend analysis involves creating visual and written representations of data from different product batches to examine how the product's behavior changes over time. It produces a detailed report tailored to the user's preferences, offering a comparison of batches based on user-defined criteria and presenting specification details in a standard spreadsheet format. Within trend analysis, there is the capability to project future trends from the data, and it provides statistical measures such as mean, median, and mode. The graph can display either a linear trendline or a logarithmic curve. It encompasses various elements, including summaries of sample conditions and sample dispositions. This module aids in the selection of vendors for approval based on analytical and sample data.
Regulatory Compliance
Audit Trail - Date wise / User wise / Function wise
Generate computer-readable copies of all operator entries with accurate timestamps, ensuring complete data retention and easy electronic data archiving and retrieval.
Document maintenance
An integrated Document Management System (DMS) is included to effectively structure laboratory data and its related documents. This system supports the management of Standard Operating Procedures (SOPs), Standard Testing Procedures, Calibration procedures, and ensures that SOPs are appropriately maintained and versioned, with a mechanism to track revisions. Additionally, it provides the capability to import SOPs from various file formats, such as those stored in common word processors like MS Word or ASCII Text, streamlining the document management process.
Security and Current user sessions - monitoring
Regulated system entry - overseeing both administrative and automated system management.
System Configurations
Internal Messaging System
A messaging system designed for OasisLIMS users to communicate with each other via email.
Alert / Reminders
When users log in, the system automatically displays alerts and reminders on the login screen window for tasks like retesting and equipment calibration, ensuring that the relevant users are informed and directed to perform these tasks.
Idle Session Timeout
If a user's inactive session extends beyond a predetermined maximum duration, an automatic timeout occurs. Upon reactivation, the session system prompts the user to provide their username and password.
Account Lockout
After three consecutive failed login attempts, OasisLIMS will automatically deny access and lock the associated account. Users will receive a notification to reach out to the system administrator for assistance in unlocking and reactivating their account. Additionally, the system maintains a record of the accounts and passwords that the suspected user attempted for administrative tracking purposes.
Email System
OasisLIMS offers an online emailing feature that allows users to send reports generated by the system to each other within a closed user group (LIMS) or to external users. This functionality leverages the services of an existing mail server.
Export Reports
The system allows users to export each report it generates online, supporting a range of industry-standard formats like Excel, PDF, HTML, RTF, Text, and more. This flexibility ensures that the system can accommodate the diverse information exchange needs of users who work with different software systems.
