OpsTrakker enhances life sciences operations by eliminating paper while improving efficiency, facilitating compliance, and unlocking manufacturing data.
Digital Equipment Use Logs: The Best Way To Track and Manage Your Equipment
STILLWATER, MINNESOTA, UNITED STATES – Enhanced Information Solution (EIS) today introduced OpsTrakker Version 1.4, bringing game changing advancements to the Life Sciences space. Built for Pharma 4.0, EIS continues to push the envelope in digital transformation. With OpsTrakker Version 1.4, we are excited to share our latest cloud developments, the deployment of batch execution workflows, enhanced integration features, smart workflows, biometric authentication, and more to expand digital records into areas which have not been able to participate in a connected workplace.
Significant Total Cost of Ownership Reduction
OpsTrakker’s electronic solutions to paper records and documents can help advance or kick-start your digital transformation. Too often, total cost of ownership, long implementation timelines, and IT red-tape, prohibit digital progress or expansion. With our latest release, OpsTrakker lays the foundation for moving from a traditional on-premise and cloud deployment to a “Cloud-Native” approach.
Our ‘Cloud Native’ methodologies and vision has the potential of significantly reducing design, build, and run costs while delivering a high-quality product that meets the voice of the customer.
Our “Cloud-Native” methodology improves agility as a quickly deployable, highly scalable, fully qualified GMP solution. Rapid deployment can drastically reduce project costs and implementation timelines to help steer you to your digitalization goals. With a focus on new methodologies and technologies, the latest release has the potential to significantly reduce the total cost of ownership, for the entire software lifecycle.
Streamlined Batch Execution Workflows
EIS has extensive experience implementing eBRs with our MES partners. Traditional MES systems are a great way to deploy electronic batch records but at times, user requirements and site capabilities prohibit full fledged MES solutions. OpsTrakker was developed to bridge the gap between paper records and an MES solution by providing a low-cost alternative that can be deployed in a matter of months. OpsTrakker may complement a company’s existing MES offerings or facilitate companies using paper solutions in starting their digital transformation, where MES solutions are not the right fit.
OpsTrakker’s lean batch execution workflow effectively eliminates paperwork and standardizes batch preparation workflows. The electronic batch execution workflow effectively achieves:
- Access to production data for analytics and process improvement.
- Right First-Time Execution for consistent production success.
- Reduce post-execution review cycles with “Review by Exception”.
The solution is GMP compliant with FDA 21 CFR Part 11 and EU Annex 11 for electronic signatures and records. OpsTrakker should not be considered a MES solution but rather a workflow engine that can remove all types of paper records including GMP Forms, batch records and equipment logbooks.
Integration Capabilities enabling IIoT
Gone are the days when you had to perform any activity twice. OpsTrakker is designed to be both connectable and connected. OpsTrakker’s latest integration features enhance your interconnected enterprise to unlock manufacturing data across the value chain. Out-of-the-box support for the latest connectivity methods promote seamless integration without sacrificing reliability or security. OpsTrakker enables IIoT through a wide array of integration points, including REST and Web APIs, OPC UA, and more to align with any organization’s automation stack. OpsTrakker is extremely flexible and easily configurable to have integrations up and running in less time and with little to no customization. Integrations with ERP systems, such as SAP or historians, including the OSIsoft PI System, provide visibility across the enterprise and enable data driven process improvement. Our latest integration features are available for our entire suite of digital solutions, to support your connected facility and IIoT ambitions.
Standardize Shop-Floor Activities with OpsTrakker Smart Workflows
Process deviations can drastically impact production consistency. Disruptions must be addressed in a methodical and standardized manner to promptly return production to a steady state. OpsTrakker Smart Workflows launch standardized activity sequences to guide shop-floor operators through corrective actions in real-time. Workflows build on alarm management and deviation procedures to automate manual activities, previously carried out with paper and pen.
How many times does an error have to occur until you realize when to stop? OpsTrakker gives you visibility over manual processes that you never had before. If you look at any digitized system, as soon as you get to the person part, there is a lot of ‘we don’t know what’s going on.’ Now we can. We can digitize those actions and prescribe an exact course of action, every time.
Such corrective functionality, paired with Review by Exception, drastically reduce product rejects, rework, and post-mortem investigation effort to improve site performance.
Biometric Authentication
Security and compliance are paramount for manufacturing applications. EIS has partnered with NYMI to provide seamless biometric authentication using the NYMI Band. With growing security demands and increased password complexity requirements, manually entering a password is not as simple as it used to be. The NYMI band is a wearable biometric device leveraging industrial IoT to wirelessly and securely authenticate shop floor activities using an individual’s unique biometric identity. Operators enjoy the state-of-the-art technology and the time savings in their daily working lives. The NYMI band was developed for privacy, security, and data integrity, as per 21 CFR Part 11 and Annex 11 requirements electronic signatures.
To learn more about how OpsTrakker can provide high-value functionality in tandem with MES or where full feature MES may not fit, contact us today! To view a software demonstration, please reach us by email at info@eisinc.com. We are excited to share these developments with your team and partner to contribute to your unique digital transformation.
Enhanced Information Solutions is a system integrator focused on making digitalization ambitions within the life sciences space a reality. EIS Specialists have a wide array of industry expertise, providing services in MES Consulting, Mobile Manufacturing Solutions, Software Validation, Operational Intelligence, Cybersecurity, and more. Consultants have expertise in all stages of the software project life cycle, including vendor selection, requirements gathering/analysis, design, implementation, validation, and ongoing support and to help you reach your digitalization goals. With offices around the world, we take pride in our lasting partnerships and shared successes to contribute to each unique digital transformation.