A Global Laboratory Informatics Company Making Labs Digital - Electronic Lab Notebook Software
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Logilab ELN is a proven and dependable system that provides a fully configurable sheet template with test- based workflow design to meet the needs of QA/QC and R&D operations for industries including pharmaceutical, life sciences, biopharmaceutical, chemical, petrochemical, environmental, food, feed, milling, and dairy.
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A Global Laboratory Informatics Company Making Labs Digital - Electronic Lab Notebook Software
- 1. A Global Laboratory Informatics Company Making Labs Digital
- 3. Our solutions are Designed to meet global regulatory compliance & Data Integrity Logilab Designed for Integrity & Compliance
- 4. A Mature & Proven ELN Logilab ELN Introduction Project/ Test/ Task Test /Experiment/Task execution Researcher study recording Inventory usage Instrument Interface Capture any instrument data into ELN from SDMS Database Backend Stores data in a central SQL-Server database Integration (LIMS/ERP) Integrates with LIMS & other systems
- 5. Logilab Functional capabilities Web Architecture Logilab ELN is a web based application. Runs on browser Template based data capture Has built-in template creation tools for data capture in a use friendly manner Instrument Data Capture Data from instruments can be captured via SDMS Database Backend Data is stored securely in a secured server database. There is non need to maintain files Structured & Unstructured Data ELN has both structured data storage using the spreadsheet & and unstructured document based data capture and storage Integrates with any LIMS/ERP/Database Logilab has been designed to integrated with external systems like LIMS/ERP or any database Mature & Proven ELN
- 6. 6 Logilab ELN Data Flow Login Capture Review Re-Test PUSH Approve
- 7. ELN Functional Highlights Making Labs Paperless Sample Management Task Management Labsheet Templates Data Identifiers for integration & reporting Template Evaluation & Validation Labsheet Data Capture Excel Management LIMS Integration Project & Workflow Instrument Integration Document editor based reporting Metalink® Android App
- 8. Powerful Dashboard Knowledge is Power • Dashboard for quick overview • Role based dashboards • Configurable dashboard • Download as report • Link to records • Alerts
- 9. An End-User configurable ELN ELN Configuration 01 02 03 04 05 06 07 08 Login Sheet/Form/ Doc Template Test Validate Release Refine Use
- 10. Administrator Effort • Setup Labsheets • Use Instrument data fields from SDMS • Use general & other data fields within sheet • Setup sheet and Test relationship • Map sheet fields with LIMS Test/Parameters Login Parsed & General fields Lab Sheet, Form, Document Design LIMS Mapping An End-User configurable ELN ELN Configuration
- 11. A User configurable ELN ELN Labsheet Configuration General & Instrument parsed fields Tool bar
- 12. Lab User Day-to-Day Activity • LIMS order sync • ELN task ordering • Researcher task ordering • Open Task sheets based on Order ID & Test / Task • Capture data in sheets (Manual entry & Instrument data) • Send results to LIMS Log Sample Open Sheets Capture Data Send to LIMS End-User Interaction ELN Data Capture
- 13. Test ELN Orders LIMS Orders End-User Interaction Test/Task Ordering Sheet Excel Orders Pending Task
- 14. ELN Data Capture Enter Data any time Formula auto calculated Instrument data auto populated Signature Fields Data is Date/time stamped Multiple-users can work on templates Data collected is versioned (data integrity) Mark activity completion Send results to LIMS any time
- 15. Calculations Performed Instrument Data Manual Data Entry End-User Interaction Captured Data
- 16. Bookmarking cells in sheet for parameter mapping One time configuration LIMS Mapping Mapping sheet cells and LIMS Test Parameters
- 17. ELN Data Capture Document type data input Insert instrument fields Insert tables Insert Images Insert Charts Insert tag fields automatically Store documents in a meaningful manner Simple document editor
- 18. User Access, Roles & Rights management • User authentication • Logilab ELN built-in • Windows ADS • User Groups • User rights • Retire/Activate users • Import ADS users • Password Policy Access Controls for better compliance
- 19. Audit Trail • 100% audit trail • User Login/Logoff • Template creation/editing • Versioning of templates • Data Capture • Who captured, When • Versioning of data • Audi Trail Review • Export of audit trail 21 CFR Part 11 ready Audit Trail
- 20. Cross Link Sheet • Create cross links from one sheet to another • Open cross linked sheet from any sheet Future proof data management Link from Laboratory Map Sheet Opens “Daily Lab Inspection” Sheet
- 21. Data Analytics & Report Creation Future proof data management • Create data link inside any sheet • Data link fields can be mapped to any other sheet Design time • Click on data link cells • Select sheet/orders to be opened • Select cell/area to copy • See that data is copied to data link cells Run time
- 22. ELN Reporting – via Document Editor Create MS- Office Documents Browser based editing (protect IP and data integrity) Collaborative working on same document by multiple users Automated insertion of data from ELN sheets Protection of non-editable text Secure server storage Authorised user can download as office documents Integration with email Office like document editor
- 23. Logilab SDMS-ELN-LIMS Seamless Integration
- 24. Logilab SDMS-ELN- LIMS Integration Data Flow Architecture Instrument Data LogiLab SDMS SDMS SQL Database Parsing Engine SDMS Explorer Web User Interface File FTP File Server Instrument Data Parsed Data REST Call Result for orders LIMS Middleware & Integration Engine Orders Generated by LIMS Middleware & Integration Engine Orders (Batch ID, Test, Parameter) Instrument sends data Results mapped to orders ELN SQL Database ELN Web User Interface WYSIWYG Template Orders/Results Results Serial Device Y/N? SDMS Explorer Tablet UI No Yes Serial Data Raw File Data RA, Sample, Test ID
- 25. Thank You
Editor's Notes
- Welcome to the overview presentation of Agaram Technologies’ Logilab Electronic Laboratory Notebook (ELN) product. First of all, let me brief everyone about Agaram Technologies: Agaram Technologies has been stablished in 1998. It is a leading provider of enterprise class Integrated Laboratory informatics software and solutions namely LIMS, QMS, ELN and SDMS. Agaram provides integrated software solutions, consulting services, product support and training to laboratories in Pharmaceutical, Healthcare, Dairy, Food & Beverage, Chemical, Oil & Gas, Environmental, Contract Research Organization (CRO), Forensics, Agriculture and Bio-Banking Industry. Agaram Technologies exclusively focuses on laboratory informatics products. It has earned a leadership position in this market by combining a world class customer experience with a powerful, yet simple and affordable suite of software products. These products have been organically built to seamlessly integrate all Laboratory related functions. It is an ISO certified organization (ISO 9001:2015) in Design, Development, Implementation, Maintenance and Support of Laboratory Information and Analytical Instrumentation Software Products and Services.
- Logilab ELN is a proven and dependable system that provides a fully configurable sheet template with test- based workflow design to meet the needs of QA/QC and R&D operations for industries including pharmaceutical, life sciences, biopharmaceutical, chemical, petrochemical, environmental, food, feed, milling, and dairy. Logilab ELN is designed to capture data in a spreadsheet like template called as Labsheet or lab notebook. Labsheet templates can be designed by scientists by dragging and dropping generic fields into the Labsheet and creating a form like input template depending on the type of test, experiment or research task. This makes the ELN usable for any digital data capture application for lab personnel, research scientists, process and process research personnel. Labsheets can be designed with data fields like text, numeric, dop-down list, date, time, formula, image, hyperlinks etc., Logilab ELN is designed to capture data from any analytical instrument that has RS232 and TCP/IP and also PC-based instruments that can either export results in ASCII, Excel, CSV formats or has the capability to can print a result report. The system is a fully scalable, flexible, enterprise system designed to streamline test or experiment along with instrument data capture (via SDMS) in a controlled environment, calculate and integrate with external system. It helps laboratories to adopt paperless processes. It ensures easy adaptability, time-savings due to faster configuration and operations and Reduced complexity to use resulting in better customer experience.
- Logilab ELN ensures that the Laboratory Organization complies with various statutory compliance standards as well as Good Practices Principles of data integrity. It includes: Good Clinical Practices (GCP) Hazard analysis and critical control points (HACCP) US FDA’s 21 CFR Part 11 Europe’s Eudralex Annex 11 Good Manufacturing Practices (GMP) Good Laboratory Practices (GLP) ISO 17025 UK’s MHRA Regulations USA’s Environmental Protection Agency Regulations International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) The advantages include paper-less record keeping system having high availability, easy access, accurate validation and tracking of records, data integrity, Audit trail information and authorised secured user access to data. It ensures that users can have a system which is highly reliable for easy Patent filing process and handling patent disputes (if any)
- Logilab ELN is designed for executing laboratory activities in an electronic format. Some of the Laboratory activities are as follows: Execution of a test or experiment. Preparation of a substance for testing the sample. Recording of research activities. All of this can be conducted in a controlled single environment without having to depend on external systems. The ELN can also receive data from analytical instruments which are connected via Logilab SDMS. The ELN stores all data in a central database repository. The ELN designed to be integrated with external systems like LIMS and ERP.
- In this slide, let us briefly discuss some of the key Functional capabilities and the advantages: 1st one is: Browser-based application architecture Logilab ELN is a Browser-based application that can be run using any of the standard web browsers such as Chrome, Internet Explorer and Firefox, etc. It offers easy access using any browser on a computer device in the network. It eliminates the need to install software on each and every instrument client as well as users’ computer systems, thus saving a lot of time and efforts and ensuring error-free installation and maintenance. 2nd one is : Template-based data capture Logilab ELN has an easy-to-use excel like drag-and-drop user interface to design laboratory task or activity templates called Labsheets. These Labsheet templates are used for data capture either manually or using instrument integration. Templates can be evaluated with test data and also validated before usage. This is a good practice and also helps regulated labs to use validated templates. 3rd one is : Instrument data capture Logilab ELN, when implemented by integrating with Logilab SDMS, can capture data from any analytical instruments that are pc-based and standalone instrument via RS232 & TCP/IP protocols. 4th one is : Secured Database Backend Data is stored securely in a secured server database. There is no need to maintain files in the system. 5th one is : Structured and Unstructured Data Storage ELN has both structured data storage using the spreadsheet & and unstructured document based data capture and storage. 6th one is : Integration with Other systems Logilab ELN is designed with a configurable/Customizable middleware Integration engine that can send/receive data from any external system like (LIMS/ERP). It has an easy-to-use mapping tool to capture data for seamless transfer between ELN & LIMS/ERP/CDS. It ensures the time and cost savings and better user experience due to reduced complexity of operations and maintenance. It also ensures error-free operations, uniformity and consistency of data extraction and processing.
- This slide shows how the data flow happens in Logilab ELN. Data flow starts from templates in which the user enters the data manually or captured from instruments using SDMS integration. If it is integrated with SDMS, Data generated and received from instruments is automatically populated into the ELN templates. Data captured can goes though a workflow for review and approval. Once the data is approved by the designated and authorised approver, it is then released to LIMS (when integrated). Data is stored in a central database repository
- In this slide, let us see some of the functional features of Logilab ELN. 1st one is : Sample Management Samples within Logilab ELN can be managed as a master list of types of samples. Additionally, ELN inventory management can be used to receive and store the samples in inventory. Samples or any material inventory item in ELN 2nd one is : Task Management Logilab ELN tasks are orders for specific type of tasks. The orders can be synched with LIMS and also the task orders can be placed within the ELN. Tasks are activities that needs some kind of recording of data either manually . 3rd one is : Labsheet Templates Logilab Labsheet templates are used for data capture. Templates can be evaluated with test data and also validated before usage. This is a good practise and also helps regulated labs to use validated templates. 4th One is : Data Identifiers for integration and reporting Logilab ELN template fields can be marked as identifiers for different purposes Exporting of specific fields as results to LIMS Taking input data for a specific field from an other template. Marking a field as tag for reporting purpose 5th one is : Template Evaluation and Validation Samples within Logilab ELN can be managed as a master list of types of samples. Additionally, ELN inventory management can be used to receive and store the samples in inventory. Samples or any material inventory item in ELN 6th one is : Labhsheet Data Capture Logilab Labsheets enables users to enter data manually and also performs formula calculations automatically. Labsheets can be designed with instrument parsed data fields, which are transferred seamlessly by Logilab SDMS. 7th one is : Excel Management Logilab ELN is a good solution to take care of excel sheets that are used by laboratories. Normally excel files can be edited at the operating system level and can be an uncontrolled document. Logilab ELN Excel orders can be used to achieve a controlled editing with version and release controls of GxP excel documents 8th One is : LIMS integration Logilab ELN is available out of the box integrated with Qualis LIMS. LIMS samples, tests and orders can flow to Logilab ELN seamlessly. After data capture, specific data or results can be seamlessly transferred to the LIMS from the ELN. 9th one is : Project and Workflow Logilab ELN has a project masters for creating and running projects. ELN task orders can be placed for specific projects and samples. ELN users can be made members of projects. ELN project data is available and visible 10th one is : Instrument Integration Logilab ELN is ready to be plugged with instruments integrated using Logilab SDMS. Data extracted from PC software based, standalone RS232, TCP/IP, Analog and clinical instruments can be easily recorded within Logilab ELN templates. 11th one is : Document Editor-based reporting Logilab ELN has a browser-based word type of document editor. Users can create dynamic reports based on ELN template tags which are auto filled via a document template. This gives the power of creating any kind of complex reports in the hands of scientists. 12th one is : Metalink Android Logilab SDMS Metalink® Android app a practical tool for locking instruments for specific ELN tasks and capturing data on the move with perfect view of instrument data while scientists have to work with different instruments.
- Logilab ELN provides easy-to-configure user-role-based dashboard which displays the information that are necessary for a specific user role to act upon as a ready-reckoner. This helps the user to see the overall pending list and configure the trend chart of specific research test results/data logger that helps to make a good decision without getting into the modules. Dashboards can be configured based on roles It ensures focussed and timely action and improving the service quality for the users.
- ELN configuration starts with a template configuration for any activity like Test, experiment or any other activity like preparation of samples, reagents etc. Templates can be designed based on the fields concept. Designed templates are tested for correctness. Verified templates are validated against sample data. Validated templates can be released for operational use. Over a period of time, templates can also be refined, versioned and released For day-to-day activities, users will use the released templates
- ELN Configuration has some of the tasks that need to be performed by the Administrator. The first one is : Setup of Labsheets. It is followed by Selecting Instrument, Methods and the other data Fields of SDMS. The fields may be of General or other types within the sheet. Optionally chemical diagrams, functions and formulae can be added. Once Sheet creation is completed and verified, it needs to be mapped with Tests thereby setting up the relationship. In this process, the fields belonging to LIMS tests or parameters are mapped correctly in ELN.
- This is the example screenshot of ELN Labsheet creation.
- In this slide, we shall briefly see how the data is captured in ELN. If the orders are created in LIMS, then it must be synced to LIMS. In case of ELN task order, they need to be create in ELN. The order may also be Research task order that needs to use flexible templates (dynamic templates are a concept the user will decide what to capture and add fields at the time of capture) The authorised user needs to open the Labsheets that have been mapped to Tests and start capturing data. This may either be direct manual one in ELN or through integration with SDMS for automatic instrument data capture. The authorised user then approves it. It is followed by sending data to LIMS.
- This is the screenshot of how the orders are processed in LIMS. The authorised user can create Test or Task orders inside the ELN. The user can also pull orders created in LIMS by synching the same. Another option is there to create research orders for dynamic templates. Options to create orders using simple excel like file storage is also available with version control.
- In this slide, we shall see some of the ELN Data capture features: Orders when opened will show up the templates Data can be entered at anytime. Users can close and capture data at different point and time Formula is calculated automatically (like excel) Data fields like (manual entry, date, time, date/time, signature) are available for ease of use Data from multiple instruments can be captured within one template After initial data capture and saving, if user captures or overwrites data, the data gets versioned (data integrity & compliance)
- This slide shows how data from different sources are populated within the sheet. Data from instruments are automatically placed in specific locations. Manual data can be entered in specific cells. Calculations are performed similar to excel and when data is populated.
- This screenshot shows how we map the ELN sheet fields to the LIMS Test/Parameters
- This is new type of template which is under development (this feature will be released during 2020) With this templates create protocols can be created and the results can be captured while executing the protocols.
- Logilab ELN has a very powerful User Management module using which the accesses and actions of the users can be controlled. Logilab SDMS has a full-fledged user access, roles and rights management system. It facilitates the following in terms of better security and control of operations. Configurable User and User group Rights Microsoft Active Directory (ADS) integration option Retire/ Activate Users Project Team configuration Password Policy configuration Session Lockout configuration Auto lock of user account
- Logilab ELN has Audit trails module to ensure better tracking and easy troubleshooting by the way of following: Capture of User Login/Logoff, Template creation, editing and versioning. Recording the User, module name, action performed, Date & Time and comments Audit Trail Review & Archival functionalities Export of audit trail to spreadsheet Users can enter comments to capture relevant information
- This slide shows how to cross link sheets. Create cross links from one sheet to another is a very important feature which adds a value to the users. In this example we have created a lab like map using the sheet merge and have filled the name of lab checklist locations Each location can be mapped to a “Daily Inspection Checklist” When you click the location automatically the “Daily inspection checklist” for the specific location will be loaded.
- Data link concept is similar to excel sheet linking of data from different excel sheets. i.e. data is filled inside a open sheet which is actually from another file. Similarly here in Logilab ELN. Users can mark a cell as “Data Link” cell. During sheet design. The data link cell can be mapped to another sheet. When user starts using the sheet with “Data link” cell. When you click the data link cell, the UI will show sheets that are mapped to the data link. User can select any one of the sheet and select the cell or area to be copied. Data from that sheet is automatically placed inside the “Data link” cell or area. The above feature can be used for data summary, data analytics etc. For example, if you want to create a summary of say “Monomer % “across several batches of process development samples. You can bring all data to a separate sheet and create a summary. Charts can also be plotted to see the trend, SPC etc.
- Logilab ELN provides a user-friendly configurable MS-word-like editing Interface to create different types of templates. Since it is very easy to understand and use, it provides a better user experience and considerable time-saving for the user operations. It has the following capabilities: Create document type content Create office documents Create form type content Integrated to insert Result Tables from Test Data Sheets Create Report Template and merge Test Results from Completed ELN Sheets. Ability to restore, download and upload folders/files Tagging of Sheet Data (Planned in future) Automatic placement of data inside document (Planned in future)
- Logilab ELN is designed with a configurable/Customizable middleware Integration engine that can send/receive data from any external system like (LIMS/ERP). It has an easy-to-use mapping tool to capture data for seamless transfer between ELN & LIMS/ERP/CDS. It ensures the time and cost savings and better user experience due to reduced complexity of operations and maintenance. It also ensures error-free operations, uniformity and consistency of data extraction and processing.
- This slide shows how data flow takes place in the integrated environment of SDMS-ELN-LIMS systems. The orders created in LIMS are first synched to ELN which has other setup like labsheets and mapping with tests and other fields readily available. In SDMS, we have data scheduler which will take care of instrument data capture and store it in a server. The results from the instruments can be parsed to a meaningful and interested data which can be sent across to ELN. ELN receives the data captured in a instrument and sent across by SDMS through middleware and integration engine. The test results thus reached ELN are processed and sent across to LIMS for further processing.