OasisLIMS 4.0 Enterprise

What is OasisLIMS 4.0 Enterprise?

OasisLIMS is a well-established product in the market that has earned the trust of many prominent laboratories. These laboratories have successfully streamlined their entire operations using OasisLIMS by automating essential lab processes through instrument integration and other high-quality management systems. OasisLIMS offers a pre-validated out-of-the-box solution with web-based functionalities and advanced customization options. This not only minimizes the time and expenses required for implementation but also requires minimal resource allocation. Pharmaceutical organizations can take advantage of this proven technology to ensure compliance with GAMP guidelines and adopt standardized industry practices across their enterprise.

  • Accelerated implementation techniques with minimal resource demands
  • In strict adherence to numerous regulatory standards
  • Consistently dependable support spanning several years
  • Built upon domain legacy, industry insight, and technical proficiency
  • Pharmaceutical-Specific Functionality
    • 100% web-based enterprise LIMS
    • Supports GxP requirements
    • Offers comprehensive functionality
    • Facilitates compliance with standards:
      • 21 CFR Part 11
      • MHRA
      • GAMP
      • ISO17025
    • Designed, developed, tested, and maintained using software quality standards

OasisLIMS 4.0 Enterprise Key Features

Key features of OasisLIMS 4.0 Enterprise are as follows:

  • The solution includes the following functionality to support pharma:
    • Management and Review of Specifications
    • Comprehensive Management of the Sample Life Cycle for Raw Materials, In-Process, and Finished Products Quality
    • Streamlined End-to-End Sample Workflow with Reporting and Charting Capabilities
    • Efficient Lot and Batch Management
    • Robust Stability Testing and Inventory Control
    • Dashboards and Alerts for Timely Reminders
    • Printing of Staged Labels for Convenience
    • Automated Online Calculations of Test Methods and Specification Checks
    • Routing and Sign-Off for Work Reviews
    • Tracking of Consumables Inventory, including Reagents and Standards
    • Rigorous Instrument Calibration, Certification, and Maintenance
    • Scheduling of Water and Environmental Monitoring Samples
    • Monitoring and Tracking of Analyst Training, Certification, and Qualification
  • A wide variety of standard functionality is available under OasisLIMS to help meet regulatory and security requirements, that includes:
    • Complete authority over the process of data review and endorsement
    • Optimal session timeout settings
    • Thorough password verification measures
    • Comprehensive version management capabilities
  • Electronic signatures and Electronic Records:
    • Configurable secure electronic signatures for all system operations
    • Comprehensive audit trail functionality
    • Enhances data accuracy
    • Improves regulatory compliance

OasisLIMS 4.0 Enterprise Master Management and Control?

Efficient management of OasisLIMS 4.0 Enterprise is as follows:

  • All Master Information
    • Materials
    • Products
    • Vendors
    • Customers
    • Units
    • Specifications
    • Various Miscellaneous
  • Management and Control
    • Referential integrity control maintains consistency in output from masters
    • Mastery control with referential integrity guarantees output stability
  • Track Masters
    • Oasis permits tracking of primary master records and their associated attributes and values, including revision history.
    • Oasis enables monitoring key master data and its related attributes and values, complete with revision tracking.
  • Sample Lifecycle and Execution
    • Ensure complete traceability for samples from start to finish.
    • Oversee the entire lifecycle of samples with end-to-end management.
  • Sample login / Receipt
    • Sample registration allows users to register a single sample.
    • During registration, users can assign a unique number to the sample.
    • The registration process also automatically assigns tests based on product specifications.
    • Samples can be logged into OasisLIMS by users outside the laboratory.
    • Samples can also be logged automatically through scheduled tasks or an ERP interface.
  • Batch Management
    • Manufacturing facilities use batch production methods.
    • They manage samples of raw, intermediate, and finished products for batch approvals.
    • Research and analytical laboratories associate samples based on work requests, jobs, or submissions.
    • Laboratories have a different approach to sample management compared to manufacturing facilities.
  • Work Allocation
    • OasisLIMS allows for automated test assignment to lab groups or individual analysts.
    • Authorized users can easily reassign tests that were automatically assigned.
    • The reassignment process is user-friendly and done through a simple interface.
  • Workflow Based Guided Sample Execution
    • Sequence of steps
      • Workflow-based sample execution cycle guides users step-by-step.
      • Users are led through configured tasks by the system.
    • Sample Tracking
      • Sample tracking system
      • Facilitates rapid sample status viewing
  • Labels with Barcode Generation
    • Print labels with formatted barcodes
      • Labels generated at various stages of the sample life cycle. Examples: under test, sampled, approved, rejected, etc.
      • System includes inventory tracking for different label types
      • Labels are printed using the system for monitoring and management
    • Worksheet Generation
      • Numerous worksheets are accessible for aiding sample processing in the laboratory.
      • These worksheets can be categorized by lab departments or according to any other logical criteria.
      • Worksheets can be displayed on the screen or printed as hardcopies.
      • Analysts can use printed worksheets to record their observations efficiently.
    • Results Entry / Analytical Quality Control
      • OasisLIMS offers a results entry mode
      • Users can choose a single sample using its descriptive identifiers
      • Upon selection, all required results are displayed for entry
      • The system includes built-in test method calculations for result generation
      • Validation procedures are integrated to ensure the accuracy of analytical methods and results
    • Results Validation / Review & Approval
      • Standard procedure in many laboratories: Review of results entered in OasisLIMS by senior manager
      • Common practice in regulated labs, especially in pharmaceuticals
      • Results validation step may be skipped when not required or when data meets specifications
      • Sample approval step confirms end of testing cycle and final disposition by lab management
      • Dispositioning of samples varies among labs
      • Common disposition statuses: Approved, Rejected, OOS (Out of Specification)
      • Communicates the outcome of sample testing to the organization

OasisLIMS 4.0 Enterprise Sample Management Module

Administer a diverse range of sample processing tasks through the utilization of multiple workflow functionalities, all while upholding laboratory protocols in accordance with standard operating procedures (SOP) and laboratory methodologies. Enhance productivity by streamlining processes and minimizing errors related to calculations and transcription.

  • Sample Management
    • Ensure end-to-end traceability for samples throughout their lifecycle within the system.
    • Effectively manage samples from initiation to completion within the system.
  • Batch Management
    • Analysis and testing of raw materials, in-process items, and finished products conducted on a batch-by-batch basis.
    • Sampling and testing performed for product batches to ensure quality and compliance.
  • Analytical Methods
    • Enhanced accuracy achieved through the utilization of validated test methods and real-time automatic calculations
    • Reduction of errors and transcription mistakes due to the automated online analysis process
  • Workflow Execution
    • The system assists users in following a predefined workflow for processing various lab samples.
    • It guides users through sequential steps to complete the tasks efficiently.
  • Inventory Management
    • Laboratory sample processing involves inventory management for standards, solutions, reagents, and other necessary items.
    • Efficiently track and control the stock of laboratory supplies for sample processing.
  • Consumables Management
    • Lab consumables life cycle management
    • Preparation and receipt of items
    • Monitoring and tracking consumptions
    • Ensuring proper disposal or destruction of items
  • Automatic Schedulers
    • Implement a recurring registration schedule
    • Define the frequency for repeated sample registration
    • Include stability assessments in the schedule
    • Incorporate environment and water sample registration
    • Include other tasks or events like reporting and notifications
  • Review Management
    • Reviewing and approving testing results
    • Evaluating and authorizing the release of submitted samples
    • Oversight of sample disposal processes
  • Lab Monitoring
    • Laboratory sample monitoring
    • Multiple locations and surfaces
    • Complete visibility
    • Status tracking
    • Processing stage monitoring
    • Execution tracking
  • Stability Management
    • Monitor stability samples in real-time
    • Analyze the shelf-life of samples
    • Conduct analysis at specified intervals
    • Subject samples to various experimental conditions
    • Track inventory of study samples
  • Instrument Management
    • Laboratory instrument management
    • Tracking instrument usage
    • Maintaining instruments
    • Calibrating instruments and components
  • Electronic Worksheets
    • Dynamic electronic worksheets eliminate the need for manual laboratory notebooks.
    • They replace paper records, reducing unnecessary paperwork.
    • These worksheets can record test readings and experimental data.
    • They facilitate collaboration among lab personnel in managing resources for sample execution.
  • Ad-hoc Query
    • Generate data queries
    • Utilize search filters
    • Apply filters to multiple attributes
    • Export data
    • Exported data format: Excel
  • Reports Designer
    • Inclusion of a built-in designer tool
    • Allows for independent design of Certificate of Analysis
    • Allows for independent design of Worksheets
    • Allows for independent design of Specification reports
  • Barcode Integration
    • Barcodes can be integrated into labels and reports.
    • The inclusion of barcodes enables efficient reading and searching of critical information.
    • Barcodes enhance data accessibility and retrieval from labels and reports.
  • Authorizations with e-Signatures
    • Electronic signature support for multiple levels of authorization
    • Chain of approvals includes Prepared by, Checked by, Reviewed by, and Approved by
    • Authorization levels assigned to system users based on their roles and responsibilities
    • Ability to reject at any stage with remarks for incorporation
    • Backtracking process for resubmission of records after rejection
  • OOS (Out of Specification)
    • CoA generation: If sample fails specification limits
    • OOS procedure triggered immediately
    • Investigation process follows standard company practices
    • Goal: Identify root cause and failures
    • User-defined investigation templates/checklists used
    • Analyst decides whether to re-analyze the sample
    • Complete OOS sample logs and non-conformance reports generated
    • OOS module interfaces with Oasis-QMS
    • Identifies, investigates, and reports laboratory incidents
    • Corrective and preventive action procedure to prevent reoccurrence
  • OOT (Out of Trend)
    • OasisLIMS tracks historical trends of test parameters for products.
    • It compares these historical results with tolerance limits.
    • If there is a deviation from benchmark/reference values, the system generates alerts.
    • The OOT module interfaces with Oasis-QMS.
    • It identifies, investigates, and reports incidents in the laboratory operations.
    • Corrective and preventive action procedures are implemented to prevent recurrence of incidents.
  • Audit and Activity History
    • Access a comprehensive list of activities
    • Activities are related to sample processing and execution
    • Activities are part of a workflow
    • Observe all activities in one place
  • Automatic Scheduler
    • Scheduler functionality allows users to set up automated tasks.
    • Users can define automatic sample logins, reports, and work intervals.
    • Utilizes a straightforward table entry format for configuration.
    • Automatically logs samples into OasisLIMS at specified times.
    • Samples are assigned the status of "new sample logged" upon automation.
    • These samples are marked as not yet received in the laboratory.
  • ELN, Electronic Lab Notebook
    • OasisLIMS ELN (Electronic Note Books) allows electronic recording of data linked to sample information.
    • It ensures accurate documentation for instruments, personnel, standards, chemicals/reagents, volumetric solutions, and procedures.
    • OasisLIMS ELN performs automatic online test method calculations, including raw data and formula details.
    • Enabling this feature eliminates the need for paper-based worksheets.
  • Corrective Action and Preventive Action
    • Identification of incidents during laboratory operations
    • In-depth investigation of laboratory-related incidents
    • Documentation and reporting of incidents in the laboratory

Lab Service Level Reports and Quick Data Retrieval

OasisLIMS 4.0 Enterprise provides lab service level reports and quick data retrieval:

  • Reporting
    • On-demand reporting and data visualization with industry standard tools
    • OasisLIMS features a powerful and flexible industry standard reporting tool
    • Capable of generating reports to meet regulatory requirements, management information, and graphical reports
    • Data stored in the OasisLIMS database is easily accessible and can be presented or printed in various report formats
    • Most reports have filters for point-and-click query creation, allowing for instant report generation
    • Offers a standard set of reports across different categories, including MIS and lab service level reports
    • Provides reports for regulatory compliance purposes
  • Dashboards
    • OasisLIMS dashboard offers quick access to essential information.
    • Easily view key performance indicators (KPIs) for informed decision-making.
    • Real-time graphical grid displays provide actionable insights.
    • Ad-hoc query functionality allows users to define data queries using search filters.
    • Data can be exported for further analysis and use.
  • User Defined Reports and Templates
    • OasisLIMS offers a user-defined reporting system with configuration options for report elements like headers, footers, and details.
    • Users can create configurable Certificates of Analysis (CoA) for different sample types, including raw, packing, intermediate, finished, water, stability, and calibration samples.
    • Configurable worksheets enable users to design the layout and format of dynamically generated worksheets.
    • Users can design various types of labels at their end using the system.
    • OasisLIMS features a built-in powerful search engine for data retrieval across the system, based on descriptive parameters like batch, sample ID, and product.
  • Data Files linking
    • OasisLIMS offers the ability to link database records with external files as attachments.
    • Clicking on these links allows easy access to and downloading of the externally linked files.
    • Users have options to configure external file storage, either in a centralized server location within a shared folder or directly within the database.
    • When stored in the database, files can be securely accessed by all OasisLIMS users.
  • Search Engine
    • Inclusion of an integrated search engine for system-wide data element retrieval.
    • Incorporation of a built-in search tool to locate data elements throughout the system.
  • Ad-hoc Query
    • User-defined data query generation
    • Utilizes search filters on multiple attributes
    • Allows users to specify criteria for data retrieval
    • Export data in Excel format for easy analysis and sharing
  • Reports Designer
    • Inclusion of a built-in designer tool
    • Ability to design the layout of Certificate of Analysis
    • Capability to design Worksheets
    • Capability to design Specification reports
    • Independent customization for each of these document types
  • Barcode Integration
    • Barcodes can be integrated into labels and reports.
    • This incorporation enables efficient reading and searching of key information.
    • Barcodes enhance information retrieval and data management.
    • Labels and reports with barcodes improve overall efficiency and accuracy.

Security and Auditing

Oasis provides security and auditing options to ensure data safety and compliance with regulations.

  • Data security
    • Implement data access restrictions
    • Determine access based on roles
    • Set access levels by department
    • Enforce object-level permissions
  • Auditing
    • Store and view record changes
    • Maintain audit logs for Master data and Transactional data
    • Include reasons for changes or deletions
    • Record details: what changes, who made them, when, and why
    • Changes cover Profile Settings, Master data, and Transactional data
  • Audit trails Report
    • User-defined filters for reports:
      • Filter by date range
      • Filter by specific user
      • Filter by activity
      • Filter by type of operation
    • Audit logs display both old and new values when changes occur.
  • Regulatory Compliances
    • OasisLIMS complies with US FDA 21 CFR Part 11, Euro Annex 11, and PIC/S guidelines.
    • It is specifically designed to adhere to regulatory compliance standards.
    • The software meets the strict requirements for electronic records and electronic signatures outlined in various regulations.
  • Single sign-on
    • Implement single sign-on (SSO) with LDAP or other SSO methods.
    • Ensure that every electronic record is associated with a timestamp and user IDs.
    • Comply with 21 CFR Part 11/Annex 11 requirements for electronic records and signatures.
    • Oasis LIMS Electronic Signature serves to verify specific actions performed by users through electronic signatures.
    • Actions such as master data registrations, changes, test result submissions, and approvals can require authentication.
    • Authentication is carried out by users using their username and password.
    • Electronic signatures include a date and time stamp and represent the authenticated action.
  • Authentic date
    • The system retrieves the date and time from the server.

System Interfaces and Instruments Integration

OasisLIMS 4.0 Enterprise offers system interfaces and instruments integration:

  • Instrument Integration
    • Interface compatibility with a wide range of networkable instruments
    • High-level instrument integration facilitated by O-Link instrument integrator
    • O-Link enables direct communication with instruments, ensuring data acquisition from diverse equipment
    • O-Link establishes connections with instruments via RS-232 port, TCP-IP, or file-based output
    • Direct access to the database from CDS desktop/server for result capture
    • Intermediate results from CDS can be utilized in calculations for final results using custom test methods
  • SAP Integration
    • SAP certified OasisLIMS bi-directional data transfer integration process
    • OasisLIMS/SAP integration customizes data communication between OasisLIMS and your company's SAP system
    • OasisLIMS/SAP interface automates sample logging from SAP to OasisLIMS and updates sample/test status in SAP
    • Communication can be event-based or timed based on implementation needs
    • Three interface levels available: text/CSV file, BAPI RFC, and web service via XI/PI
    • SAP interface is tailored to each installation due to varying integration architecture.
  • 3rd Party Application Integration
    • ERP (SAP, Navision, Oracle, JDE etc.)
    • PIMS (Aspen Tech IP 21, OPC Server)
    • SQC

Integrated Validationed Support

OasisLIMS provides a comprehensive implementation strategy aligned with GAMP guidelines, featuring a meticulously outlined validation plan and execution procedures. This solution offers meticulously documented validation processes for its product deliverables, meticulously crafted by seasoned validation experts with a profound grasp of regulatory mandates. These services cater to organizations operating in regulated sectors, aiding them in compliance adherence. OasisLIMS support services encompass validation planning, test script development, and execution assistance.

  • Clear Validation Master Plan
  • User Requirements addressing industry processes
  • Detailed Functional Specification for standard features
  • Protocols (IQ/OQ/PQ) and verified test scripts aligned with product workflow
  • User manuals and standard operating procedures, including security, deviations, and change control forms
  • Traceability Matrix, Validation Report, Validation Summary, and System Release Documents

Configuration and Framework

OasisLIMS 4.0 Enterprise Configuration and Framework:

  • In-Built Configuration tools
    • Customize and expand the user interface
    • Enhance data profiling capabilities
    • Extend business logic
    • Achieve these tasks without the need for programming
  • Multi-Plant Operations
    • OasisLIMS Multi-Site Architecture
    • Enables a single OasisLIMS implementation
    • Restricts access to information and functions
    • Tailored for individual laboratory groups at specific sites
    • Ideal for managing multiple plants within a single database
    • Operates seamlessly over a Wide Area Network (WAN)
  • Email - Internal / external
    • Internal Oasis mail system for LIMS users
      • Allows users to exchange messages among themselves
      • Provides standard functionality including compose, broadcast, multicast, and attachment options
    • External email configuration via SMTP
      • Enables automatic generation of emails for customer-specific actions and reports
      • Examples of automated emails:
        • Test reports
        • Certificate of Analysis (COA)
        • Out of Specification (OOS) notifications
        • Event-based notifications
        • Schedules and reports
  • Integrated SMS Mobile gateway
    • Provide instant messaging and notification alerts via SMS on mobile devices for important events and advanced notices to alert users.
  • Backup and restore/recovery
    • Inclusion of a built-in backup and restore feature
    • Offers various modes for backup and restore operations
    • Supports scheduled backups
    • Allows for unscheduled (manual) backups
    • Can back up data to different mediums, folders, or directories
    • Supports backup to various devices
  • Notifications
    • Automatic alerts and reminders are triggered upon login or other events.
    • Alerts include samples due for retesting.
    • Reminders for equipment calibration are generated.
    • Alerts for samples slated for destruction are sent.
    • Notifications for samples needing sampling, analysis, review, or work assignment are issued.
    • Notifications for reference standards due for standardization are activated.
    • Alerts are sent for samples pending stability analysis.
    • The system offers easier implementation and management of these reminders and alerts.
  • Data import
    • Import data from various file formats: CSV, delimited, XML, and Excel
    • Process imported data for the creation of initial set-up masters
  • Export reports
    • New report generator upgrade
    • Enhanced feature
    • Online export capabilities
    • Supports various industry-standard formats
      • Excel
      • PDF
      • HTML
      • RTF
      • TEXT
  • Electronic Worksheets through eForms (Optional Module)
    • Input observation data
    • Use standard templates
    • Multiple analytical methods supported
    • User-friendly interface
    • Resembles paper-based input forms
  • Web services to Interface
    • Industry standard web services include XML, SOAP, and JSON formats.
    • These web services facilitate seamless data communication.
    • Integration with other systems on an enterprise network is made easy.
    • XML, SOAP, and JSON ensure compatibility and interoperability.
    • These protocols support efficient data exchange within the industry.
  • New User Interface, an improvised user experience
    • Outstanding user interface
    • Enhances user experience
    • Simplifies navigation of system items
    • Offers multiple access methods
  • Home Screen Panels with Advanced Look and Feel
    • Quick and easy access codes for fast navigation
    • Drill-down options for viewing and updating information
    • Panels with shortcuts for efficient navigation
    • Smart navigation to screens, reports, notifications, alerts, reminders
    • Quick links to recently accessed items
    • Time-saving features on the home screen
    • Streamlined startup process after initial login
  • Enhanced Operational Ability
    • Quick searches based on user-selected parameters
    • Enhanced navigation for ease of use
    • Faster information retrieval
    • Improved productivity and efficiency
  • On-Line Context sensitive help
    • Comprehensive electronic help
    • Indexed Table of Contents (TOC)
    • Detailed assistance
    • Hyperlinks for easy navigation

OasisLIMS 4.0 Enterprise