Table of Contents
- 1 What is OasisLIMS Professional?
- 1.1 Master Specification Maintenance
- 1.2 Sample Management
- 1.3 Sample Login
- 1.4 Worksheets and Labels
- 1.5 Result entry and Test Methods/Calculations (User Defined through Excel Interface)
- 1.6 Generation of CoA - Certificate of Analysis
- 1.7 Reporting
- 1.8 Regulatory
- 1.9 MIS
- 1.10 Sample Scheduling
- 1.11 Equipment Calibration and Maintenance
- 1.12 Inventory Management
- 1.13 Standard Operating/Testing Procedures
- 1.14 Auditing
- 1.15 Easy to Use Interface
What is OasisLIMS Professional?
OasisLIMS Professional is an all-encompassing laboratory information management software that operates both as a web-based and client/server solution. It is designed to cater to the needs of small and medium-sized laboratories across a wide spectrum of laboratory tasks. With its inherent capabilities, OasisLIMS Professional allows you to efficiently oversee the sample flow and associated data, ultimately enhancing laboratory productivity. It plays a pivotal role in standardizing workflows, tests, and procedures, all while maintaining precise control over the entire process. The system seamlessly incorporates real-time calculations to log test data, thus reducing errors. Additionally, it includes a module for resource allocation within the lab, ensuring that instruments used in analysis are correctly calibrated and operated solely by trained and qualified personnel. Furthermore, it safeguards that chemicals, standards, and reagents utilized in analyses are appropriate for their intended purposes.
- Key Functions of OasisLIMS:
- Revision control of masters
- Encourages organizations to adopt LIMS and transition to a paperless system
- Compliance with best practices and regulatory requirements, particularly in pharmaceutical and major regulatory organizations
- OasisLIMS Professional Configuration:
- Customizable to include audit trails
- Captures changes related to results, test procedures, instruments, and chemicals used during analysis
- Benefits of Implementing OasisLIMS Professional:
- Saves valuable man-hours of technical staff
- Reduces time spent on writing and checking individual reports
- Frees up saved time for more important and productive tasks in the laboratory
- The primary objective of OasisLIMS is to enhance laboratory efficiency and precision through the reduction of manual tasks, encompassing a spectrum of essential functions including
- Sample Management
- Workflow management
- Test data record keeping
- Automatic test method calculations
- Inventory management
- Instruments management
- Administration and control
- Flexible Reporting
- Trending and Analytical Quality Control
- Standard Operating Procedures Maintenance
- Instruments Management
- Inventory Management
- Auditing and Security
- Simple User Interface
Master Specification Maintenance
The specifications pertaining to raw materials, packing materials, intermediates, bulk products, finished products, water quality, standards, and solutions should be designed in a manner that facilitates easy maintenance and includes a comprehensive history of revisions. This ensures that there is no necessity to repeatedly reference these specifications during the analysis process. Such a system streamlines the workflow and enhances efficiency by providing readily accessible and well-documented information about the various components involved in the manufacturing or analytical processes, ultimately contributing to the overall quality and consistency of the final products.
The core of daily laboratory operations revolves around sample management and laboratory workflow. OasisLIMS offers comprehensive support for various laboratory functions, including efficient management of tasks such as sample searching and display, sample registration, tracking and auditing, test maintenance, test result entry, result review, release and approval, certification, and reporting, among others.
When a production intimation or GRN is received, the software initiates a sample login process with minimal parameters. This software offers a versatile range of login options, including normal sample, retest, pre-shipment/pre-purchase, reanalysis, market, and control, among others. It also provides the functionality to automatically generate a unique Sample ID or Analytical report No for different sample categories. Users can input sampling plans for each product or material and record sampling details and observations. Additionally, there is the flexibility to conduct partial or reduced analyses, and the software automatically assigns tests to the samples. Furthermore, users have the option to add new tests or modify limits after sample registration as needed.
Worksheets and Labels
OasisLIMS enables users with the necessary permissions to effortlessly customize the layout styles and formats for each test, presenting sample and test data in a workbook format with a sequential numbering system. No programming skills are required to make these edits.
- Customizable worksheet format for data entry aligned with the Drugs and Cosmetic Act, its rules, or in-house testing protocols.
- Automated creation of dynamic worksheets for various categories like raw materials, packing materials, intermediates, bulk, and finished products.
- Worksheets detail the required tests in accordance with established standards or in-house specifications.
- Optional inclusion of analysis methods within the worksheet.
- Capability to generate labels for different sample stages, such as under test, sampled, approved, or rejected.
Result entry and Test Methods/Calculations (User Defined through Excel Interface)
You can enter work allocation, result entries, and test-specific or sample ID-specific data in various flexible input formats. This allows for qualitative and quantitative analysis, including descriptions, compliance status (conform or non-conform), and predefined validated calculations for parameters like LOD, Assay, Purity, UOC, Dissolution, GC/HPLC, average weight, and more. Additionally, there is provision for user-defined test method calculations.
- Eliminates calculation errors
- Saves time for chemists
- Allows laboratory technicians to focus on value-added tasks
- Automatic generation of calculation sheets and raw data sheets
- Detailed Certificate of Analysis (CoA)
- Test method calculations are validated, reducing the need for result verification
Generation of CoA - Certificate of Analysis
OasisLIMS produces Certificates of Analysis (CoA) that can be customized with different layouts to suit the specific sample type. The CoA generation process includes a validation step where results are compared to specified limits to determine whether a sample should be approved or rejected. Based on this assessment, the system automatically generates a disposition status. In instances where a sample does not meet the required criteria, the final report includes rejection details. This system is designed to make independent decisions, reducing the potential for biased opinions.
OasisLIMS Professional features a robust and adaptable industry-standard reporting tool, capable of generating a diverse range of reports to meet regulatory mandates, management needs, and graphical data presentation. The data stored within the OasisLIMS database is easily accessible and can be exhibited or printed through a wide array of report formats. Many of these reports come equipped with filters, allowing for effortless query creation through simple point-and-click interactions, resulting in immediate report layouts. OasisLIMS offers a standardized collection of reports across various categories, supporting Management Information Systems (MIS), laboratory service-level reports, and reports designed for regulatory compliance.
Specifications, Work Sheet, CoA - Certificate of Analysis, Sampling sheet, Sample register, Rejection register, Labels (under test, approved, rejected, sampled, quarantined etc.)
- QC productivity
- Analyst performance
- Samples pending for sampling
- Samples pending for analysis
- Samples pending for entry of results
- COA pending for review
- COA pending for printing
- Lab performance report on various parameters
- Sample approval status
- Samples for retest
The OasisLIMS scheduler enables the creation of customizable schedules and automates the registration of samples, as well as the occasional generation of reports. This functionality aligns with the common industry need to process samples at regular intervals. By leveraging the robust scheduling capabilities of OasisLIMS, the system can automatically identify and issue alerts or reminders for sample processing, reducing the risk of oversight associated with manual control. The built-in scheduler utilizes rules established through data management tools to instruct the system on its tasks and timing.
Equipment Calibration and Maintenance
The Equipment Management Module offers comprehensive features for users to establish and effectively oversee the equipment utilized in sample analysis. This module facilitates the tracking of calibration schedules and the documentation of calibration outcomes, while also maintaining real-time data for monitoring equipment usage and performance. Users have the capability to schedule and oversee instrument maintenance tasks, and they can set up alerts to notify them when maintenance deadlines approach. Additionally, the system maintains a comprehensive record of the equipment's maintenance history.
OasisLIMS integrates a comprehensive system for controlling and managing stock and inventory. This module encompasses the entire process of managing items such as chemicals, glassware, reagents, and solutions within a laboratory, from their receipt to their utilization in the analysis of various types of samples. The inventory and storage management capabilities of OasisLIMS enable users to effectively monitor the availability and expiration dates of these items. Moreover, the system automatically generates alerts to reorder items when their inventory levels fall below a predefined threshold. This combination of inventory management software and tracking procedures makes OasisLIMS an indispensable tool for any laboratory. The system also provides reporting features to monitor stock receipts and consumption, along with other valuable details. Additionally, OasisLIMS offers the capability to print labels for easy identification of consumables.
Standard Operating/Testing Procedures
OasisLIMS offers an integrated word processing feature for the management of Standard Operating Procedures (SOPs) used across various laboratory activities, serving as essential guidelines and references for quality procedures. These SOPs can be modified directly within OasisLIMS using standard editing functions and securely stored within its database. Alternatively, they can be imported from external applications like Microsoft Word™.
Additionally, there is an option to attach files while efficiently organizing them through folder management, all tagged with unique document IDs. These attachments are stored as Binary Large Objects (BLOBs) within the OasisLIMS database to ensure maximum security. SOPs can be versioned to keep the most current version at the top, and aging of SOPs is also supported for proper documentation maintenance.
OasisLIMS features an extensive audit trail and trace log capability, offering you the ability to create an audit record for every action taken within the system. This enables you to review alterations, their timing, the reasons behind them, and the responsible party. All changes are meticulously documented and securely archived for later scrutiny and reference.
Easy to Use Interface
The familiarity and user-friendliness of OasisLIMS' interface are crucial for boosting productivity and minimizing the time required for user training. New users can quickly become skilled, and occasional users can effortlessly maintain their proficiency thanks to this interface that resembles Microsoft Office. Drawing inspiration from the familiar features found in Microsoft Excel™, OasisLIMS offers a structure with workbooks, worksheets, folders, and sample management, enabling users to replicate their laboratory's operational processes without the need for intricate IT assistance.