Electronic Batch Record (EBR)

The AgiLab platform has fully functional, preconfigured capabilities for managing the end to end processes for products and formulations development. This includes:

• Formulation management
• Product composition
• Recipe management with composition calculator
• Batch management

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 users to:

• Track batch creation
• Identify equipment/lines used with last calibration date
• Weigh 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 users to:

• Maintain multiple schedules for each instrument (daily, weekly, monthly, etc.)
• Manage preventive maintenance, calibration and qualification schedules
• Log unplanned 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 work order 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 the requestor and the 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 allows 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 requirements.

The AgiLab platform automatically flags and immediately compares results in real time against defined specifications for immediate response. Alerts can be automatically generated 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 manage key document as SOPs, keep track of any incident and related personnel training.

Document management: 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

Training management: 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

Incident management: 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

The 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
• Use business intelligence dashboarding
• Measure and report metrics and KPIs
• Deliver enterprise level system monitoring

In addition, our analytics capabilities are designed to deliver predictive analytics, natural language and semantic search capabilities to support big data and advanced analytics strategies.