OpsTrakker GMP Solutions
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Increase the speed and quality of pharmaceutical production with OpsTrakker eBR Software
Traditional MES Solutions do a great job in deploying electronic batch records. We have extensive experience implementing electronic batch records with our MES partners and advancing digitalization efforts. At times, user requirements and site capabilities prohibit a full fledged MES solution. OpsTrakker’s batch manufacturing record software bridges the gap of a traditional MES solution and a paper system, and provide a low cost alternative that can be deployed in a matter of months. OpsTrakker’s eBR may complement an organization’s existing MES offerings or assist companies using paper with their digital transformation. By leveraging more than 25 years of experience in the industry, our offering can eliminate paperwork and standardize lightweight electronic batch records.
Avoid the risk of human error. Electronic batch records ensures that every activity is precisely recorded and documented in accordance with regulatory requirements. OpsTrakker’s workflow engine facilitates operator activities during batch production, to standardize each activity, while eliminating paper form the shop-floor. The solution leverages review by exception to highlight deviations, discrepancies, and errors, to significantly reduce post execution review cycles. In turn, enabling prompt corrective action as well as process insights to promote effective and efficient process improvement.
A Lean eBR Software for the Life Sciences and Pharmaceutical Industries
Few industries require the same regulatory requirements as the pharmaceutical, biotechnology, and medical device industries. Paper-based records are no longer up to the job. Completing paper-based batch documentation is time-consuming and prone to human error, often requiring dozens, if not hundreds of papers and forms to complete. Furthermore, the labor intensive review process, may lead to further production delays.
OpsTrakker’s lightweight eBR software improves manufacturing productivity and facilitates compliance through streamlined data capture and electronic signatures. The batch manufacturing workflow engine guides manual activity completion to facilitate right first time execution. Electronic entries are safeguarded with validation checks and leverage review by exception to improve post-execution review cycles.
All batch documentation and records are digitally secured in a central location and can be accessed anytime from anywhere. Ease of retrieval can significantly enhance your organization’s ability to review the batch, and analyze for process improvement.
OpsTrakker eBR Module
Electronic batch records are an online solution that automate manual activities within a batch production and packaging. OpsTrakker’s engine eliminates human error, while improving production output and standardizing operator activities. The solution bridges the gap of a traditional MES solution and a paper based system, to replace paper and advance digitalization ambitions, without introducing too much complexity.
Solution features
- 'Review-by-Exception' to significantly reduce post-execution review
- Activity Sequence Enforcement for guided manual activity completion
- Integration with ERP systems (i.e. SAP) for equipment, material, and inventory status management
- Integration with historians (i.e. the PI System)
- Barcode and QR Code Data Entry for reduced error and effort
- Configurable user groups and user functions
- Mobile Ready, available on Native App or Supported Browsers
- Biometric Authentication with the NYMI Band
Problems solved
- High cost and inefficiencies associated with recording, scanning, and storing paper-based forms
- Paper transportation across various locations
- Illegible completion of paper forms
- Incomplete or inaccurate data input
- Requirements for wet signatures
Benefits delivered
- Access to Shop-Floor Data for Analytics and End-to-End Visibility
- Regulatory compliance with FDA 21 CFR Part 11 and EU Annex 11
- Right First Time Execution
- Reduced review cycle times with "Review-by-Exception"
- Improved operator efficiency
- Support for Cloud or On-Premise Hosting
- Eliminate any/all paper from your workflow
- Provides an audit-ready environment
Frequently Asked Questions
An Electronic Batch Record (EBR) is a digital record used to document the manufacturing history and execution of a production batch. EBR systems replace paper batch records with controlled electronic workflows that capture process steps, operator actions, materials, equipment information, approvals, and other GMP manufacturing data. OpsTrakker eBR enables pharmaceutical and life sciences manufacturers to digitize batch execution and create structured electronic batch records.
Electronic batch record software manages the digital execution and documentation of manufacturing batch processes. OpsTrakker eBR guides operators through defined manufacturing activities while capturing required data, electronic signatures, timestamps, exceptions, and other information needed to create a complete electronic batch record.
Electronic Batch Records replace handwritten batch documentation with guided digital workflows. Instead of manually completing and reviewing paper records, OpsTrakker eBR enables operators to execute manufacturing activities electronically while required information is captured and validated throughout the process.
Electronic batch execution uses digital workflows to guide manufacturing personnel through the steps required to produce a batch. OpsTrakker eBR can provide operators with the appropriate instructions, data-entry requirements, verifications, signatures, and workflow steps while creating the associated Electronic Batch Record.
An Electronic Batch Record can capture operator actions, process steps, equipment information, material information, quantities, timestamps, electronic signatures, process values, verifications, comments, exceptions, and approvals. OpsTrakker eBR creates structured digital records that provide traceability throughout batch execution.
Electronic Batch Record systems used in regulated environments can support 21 CFR Part 11 requirements through electronic records, electronic signatures, audit trails, user authentication, access controls, and record traceability. OpsTrakker is designed for regulated pharmaceutical and life sciences manufacturing environments.
Electronic Batch Records can improve data integrity by capturing information directly at the point of execution, enforcing required fields and process steps, maintaining timestamps and audit trails, and reducing handwritten entries and manual transcription. OpsTrakker eBR creates structured and traceable digital records throughout batch execution.
Review by exception allows reviewers to focus on deviations, exceptions, missing information, out-of-range values, or other conditions requiring attention instead of manually reviewing every element of a batch record. OpsTrakker eBR can help streamline batch record review by identifying information that requires additional review.
Yes. Electronic Batch Records can reduce review time by validating information during execution, identifying incomplete or exceptional entries earlier, and making records immediately available electronically. Review-by-exception capabilities can further help quality personnel focus their attention on information requiring investigation or approval.
An Electronic Batch Record focuses on digitally executing and documenting the activities required to manufacture a batch. A Manufacturing Execution System (MES) can manage a broader range of production execution functions across a manufacturing operation. OpsTrakker eBR provides electronic batch execution capabilities and can be used as part of an Agile MES strategy or alongside existing manufacturing systems.
Yes. Electronic Batch Record software can integrate with systems such as ERP, MES, LIMS, QMS, equipment systems, and other manufacturing data sources. OpsTrakker is designed to connect digital batch workflows with the broader manufacturing technology environment.
Electronic Batch Records eliminate paper from one of the most documentation-intensive manufacturing processes. OpsTrakker eBR digitally guides batch execution and captures manufacturing information as structured electronic records, reducing reliance on printed batch records, handwritten entries, manual reconciliation, and physical document storage.
Electronic Batch Record (EBR) and Electronic Batch Manufacturing Record (eBMR) are closely related terms used to describe digital records of batch manufacturing activities. Terminology can vary between organizations, but both generally refer to electronically capturing the execution, data, signatures, and manufacturing history associated with a production batch.
OpsTrakker eBR is Electronic Batch Record and digital batch execution software designed for pharmaceutical and life sciences manufacturing. It replaces paper-based batch records with controlled digital workflows that guide execution, capture structured manufacturing data, maintain traceability, and support more efficient batch record review.