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 Lite 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 Lite 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