Enable paperless batch record and execution guidance
Why the AgiLab EBR?
AgiLab EBR is one of the most flexible digital application for execution guidance of any batch recipe.
The AgiLab EBR is designed for companies that want improved batch record without the large complexity of Manufacturing Execution System (MES) system.
Through a flexible, intuitive user interface, the AgiLab EBR combines data capture, workflow design in automating the execution and review of batch records
Thrive your digital transformation and benefit from a high level of traceability and compliance with the AgiLab EBR:
Replace paper batch records, spreadsheets
Centralize all the batch information
Follow the operations to execute according process step
Automate data capture from equipment and warehouse inventories
The AgiLab Platform has fully functional, preconfigured capabilities for managing the end to end processes for products and formulations development. This includes:
Recipe management with composition calculator
The AgiLab Platform manages all processes from creation of a product or formulae and batch identification to result entry and reporting. The platform is designed for managing formula recipes with existing sub-formula, raw materials, ingredients and other components with graphical process design. Recipe creation complies fully with ISA-88 and ISA-95 standards to help optimize technology transfer from R&D to manufacturing.
Companies have traditionally used paper to maintain batch records. Under 21 CFR Parts 210-211 regulations, the electronic batch record (EBR) must demonstrate the accomplishment of every significant step in the production of each batch of a product.
The AgiLab platform allows to:
Track batch creation
Identify equipment/lines used with last calibration date
Weight components/materials used
Capture in-process and laboratory control results
Complete labelling control records
Define a electronic signature for each step
A regulated environment needs robust equipment management. Every piece of equipment that requires calibration based on the manufacturers schedule or the internal SOP of the laboratory should be calibrated at regular intervals. It is essential that the calibration results are recorded, along with calibration status, dates and availability of that instrument for use in the laboratories.
The AgiLab platform allows to:
Maintain multiple schedules for each instrument (daily, weekly, monthly, etc.)
Manage preventive maintenance, calibration and qualification schedules
Log un-planned maintenance
Control the availability of instruments for test usage
Record instrument usage logs for every sample or test
Print instrument labels or integrates with third party labelling software
The AgiLab Platform manages and facilitates workorder between departments. Formulators, scientists and collaborators can manage the submission, receiving, tracking and reporting of results originating from lab work requests and test orders through an intuitive interface.
Direct collaboration between requestor and executor of the work
The analytical testing features include the ability to request one or more tests to be performed on one or more samples. It will allow laboratories to:
Enter requests with key information through intuitive “wizards” and business rules
Apply higher priority to specified samples and tests
View the status and progress of requests
Specifications allow laboratories to ensure that products meet standards and customer-specific.
The AgiLab Platform automatically flag and immediately compare results in real time against defined specifications for immediate response. Alerts can automatically generate to inform analysts if quality criteria are not being met and to:
Centrally manage and control specification limits with business rules
Check specifications throughout processes
Log Out-of-Specification (OOS) occurrences through a rigorous workflow path
Accept or reject batches
Enforce SOP and protocols
In GMP and ISO17025 compliant areas, it is important to manageme key document as SOPs but as well track of any incident and related personel training
The AgiLab platform offers a centralised repository to ensure secured documentation with controlled access to:
Edit online with our embedded Office document editor
Define workflow based document approval
Assign tasks and manage their lifecycle
Control document revision
Search with full text capabilities
personnel are required to undergo training on key business processes including methods, SOPs, testing and instruments.
GMP and ISO17025 guidelines stipulate that only trained staff are allowed to run tests or use the associated equipment.
The AgiLab platform allows you to:
Schedule and plan training
Keep personnel informed about planned training
Keep quality and training documents updated
Only display specific techniques to trained personnel
Allow only trained users to perform certain operations
Generate a competency matrix report
Integrate with external training management systems
It is important to keep track of any incident such as Out-of-Specification and deviations during process execution.
The AgiLab platform allows users to manage the full incident lifecycle including:
Register incidents such as deviations
Enter specific metadata according to incident type
Complete incident investigation
Set actions to execute and monitor status
Review and evaluation of incidents
Integrate with external incident management systems or quality management systems
The AgiLab platform leverages Oracle technology to provide enterprise-ready, secure means for bi-directional interfaces such as web services, file exchange, database links and more.
Typical integrations with external systems
including, but not limited to:
Enterprise Resource Planning systems (ERP)
Chromatography Data Systems (CDS)
Equipment calibration and metrology systems
Enterprise Document Management Systems (EDMS)
Quality Management Systems (QMS)
Statistical analysis systems
Manufacturing Execution Systems (MES)
AgiLab's approach for instrument integration is to provide generic configurable interface mechanisms, rather than hard coded integrations to a specific list of instruments. We provide out of the box plugins for:
Waters Empower Chromatography Data System
Mettler-Toledo LabX system
Tne AgiLab platform is a centralised repository for all structured and unstructured data means that, once captured, data is fully searchable and can be used for trending and reporting.
The AgiLab Platform allows you to:
Collate results and other information across experiments and tests
Generate summary information on the status of their projects and experiments
Business intelligence dashboarding
Measure and report metrics and KPIs
Deliver enterprise level system monitoring
In addition, our analytics capabilities is designed to deliver predictive analytics, natural language and semantic search capabilities to support big data and advanced analytics strategies.
Face the challenges of your industry with the AgiLab EBR
Our team is at your disposal to discuss your laboratory digital projects and goals.
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