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Oasis-EBR Electronic Batch Records


An integrated software for maintenance of batch manufacturing and packaging records, electronically! On-line manufacturing records entry through electronic batch records (EBR) with electronic work instructions (eWI); Easy compliance with cGMP Regulations.;Specifically designed for pharmaceutical / API / Chemicals manufacturing units. Escalation of batch records helps improve process management efficiently, increases quality, and ensures compliance.

Key features offered by Oasis EBR ...

Master Batch Records (MBR)
Pre-configured forms/Files Forms/Documents outline/Details of Mfg. processes Governs an individual Mfg. run Pre-Defined/Configurable Templates
Documents Preparation
Upload Attach/Link – files Quick Storage and Retrievals Under Secured Database Operations Completely User Defined Reuse Existing BMR/BPR documents
Production Batch Records (PBR)
Macro Objects for process parameters recording Capture all related information of Mfg. process Mfg. procedures as Electronic Instructions Multi-page information capturing Paper-less Manufacturing
Process Workflow Automation
Sequence of operations/Automatic routing Serial Steps / Adherence to workflow Complete recording and verification of INFO
QA Stage Approvals
Reviews and approvals Authorization / Electronic Signatures Feedback submission at all levels Track and Trace
Automatic Notifications
Reviewers and approvers automatically notified Off-line alerts and reminders
Pending for review, for approval, for action BR printing Master Batch Records/Controlled Copy Batch Manufacturing Records Batch Packing Records Manually stamping paper pages to ensure accurate manufacturing/production records is a time consuming and costly endeavor. Electronic batched printing of records provides a controlled solution for producing consistent documentation for paper-driven processes. Issuing consistent manufacturing records (BMR/BPR) has never been more convenient than with the BPR pre-stamped lot number feature.

Business Benefits

Batch operations conducted and maintained manually are inherently inefficient, slow and cumbersome. Oasis EBR system streamlines and standardizes work practices on shop floor. Eliminates stamping each page of a record with lot numbers/batch numbers/ticket numbers/etc. Simply type batch related information at once and it populates statutory information in all required locations within the records and relevant documents.

Eliminate and streamline work practices, Reduce complexity of printing Embed knowledge of printing records, effectively manage manufacturing records Rapid employee adoption and use, Flexible printing solutions, Regulatory compliance Microsoft .Net application built for secure document management, as well as simplified change management and validation, Option to Interface with ERP / LIMS system Document Control & Archiving (DCA) / MPCR, Recipe Authoring (RA), Equipment Tracking (ET), Materials Management (MM) / Weighing and Dispensing, Electronic Batch Records (EBR) , Security & Audit (SA)
Oasis EBR automates escalation of batch records for more efficient process management, The process entries such as tare and gross weights, start and end times, environment parameters and setup verifications etc. can be recorded on line. Pre-configured forms simplify data collection and help minimize errors common in manual data collection. Separate Fully Functional Module with user access restrictions .

Integrated key functions offered by Oasis EBR ...

Electronic Templates, flexible

Built in word processor for maintaining batch and packaging records as standard template* with each product formula / recipe, Every stage has templates attached to it (meant for recording process parameters, observations and operators entries), Provision for revisions. *programmed configurable eFoms having manufacturing procedures/instructions and provision for user entries inputs with text boxes, check boxes, option buttons and calculations

Attachments e-Forms

Creation of Production login / work orders (new batches) automatically attaches standard templates as on-line electronic forms (eBMR) for subsequent recoding of process parameters, observations and operators entries

Real-time Operators Entries/Recording

Provision for user entries inputs with text boxes, check boxes, option buttons and calculations, Synchronized with production workflow

Approval System, Authenticate Action

QA approvals and controls with every stage, Any deviation or exception can be commented with corrective action

Time Stamping / Electronic Signatures

System time date stamping with shop-floor manufacturing; provision for electronic signatures

Automatic Tracking

Oasis BR tracks all routing information and data entered into the electronic form, allowing the batch coordinator to follow the overall process, identify bottlenecks, and understand the sequence of events during processing. Physically tracking logs, test results, and other records from different areas is time-consuming. A manual process makes it almost impossible to avoid bottlenecks, a serious problem in case of a need to identify defective batches.

Data Capturing from ERP

In-line insertion of relevant informaton from ‘Production Module’ to eForms, batch details, product formula, issuance records, issue returns, man/machine operators entries

Effectively Manage Manufacturing Records

Easily transform paper-based manual manufacturing record systems into a computer-supported system. Existing documents compatible with MS Word/ASCII text can easily be imported and attached with EBR database, reduces time for master preparation while implementation.

Reduce Complexity Of Printing Records

Batch manufacturing records often comprised of various documents that are printed separately and compiled later. With Oasis-eBR, the compilation of various documents is done adherence to Master Batch Control Record, so that one never forgets a form or document again.

Rapid Adoption and Use

Attractive and easily understood production record printing application guarantees rapid employee adoption and use.

Embed Knowledge

Oasis EBR system standardizes the knowledge of work practices; this results in reducing repeated higher training costs and less room for errors. With Oasis-eBR, you can embed work practices within the application so that the knowledge of manufacturing process remain and maintained with in the system. The practice would be system driven then man driven.

Regulatory Compliance

Automatic audit trail and other control measures ensure cGXP and 21CFR Part 11 compliance for those industries requiring such.

Equipment Interfacing through O-Link Server

To capture / upload data from weighing and dispensing instruments installed on shop-floor.

User Administration

Plant Master, System Users, User Profiles, User Session, Web Browser, Un-Authorized Use Report, Backup Database, Recover Database, Function Key, Format Master, Logout, Lock, Change Password, Preference, Mail, Alert/Reminder, Exit

Integrated Equipment Management, (optional)

Equipment Type Master, Equipment Unit Master, Equipment Master, Equipment Maintenance, Equipment Test Master, Equipment Test Link, Calibration Login, Calibration Reading/Observation, Equipment Master List, Equipment Test Link printing, Calibration Worksheet, Certificate of Calibration, Equipment Calibration Status, Equipment Due for AMC, Equipment Maintenance Report, Equipment Due for Calibration, Equipment Calibration Calendar, Equipment Pending for Calibration, Equipment Register, Alerts and reminders (pop up window)