Seamless Integration from Data to Knowledge
Life Sciences
Delivering solutions which support timely process understanding and decision making through end-to-end structured management of all aspects of product development, Tech Transfer, and full-scale production
Stay Competitive with Integrated Batch Solutions
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Easily achieve good manufacturing practices (cGMP) |
Improve traceability |
Save time, effort and costs |
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Make smarter, faster decisions |
Improve availability |
Reduce validation time |
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Increase production speed |
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MES Business Integration Goals
- Follow industry best-practices, including standardized message schema for industry compliance
- Improve real-time data capture between systems by utilizing event-based integration architecture
- Reduce technical cost of ownership and improve adaptability by reducing custom components
- Improve development efficiency by leveraging existing design/configuration whenever possible
Key Outcomes of a Connected Plant
- Electronic Batch Records
- Parameterized Recipes
- Review-By-Exception
- Central Dispensing
- Electronic Equipment logs
- Additional Data Integrations
- Material Tracking System
- Laboratory Information Management Systems
- Scales
Validation Strategy
- CSV Deliverables Embedded in project Methodology – NOT activity after software delivered
- Collaborate and have agreements with CSQA
- Just-in-Time formal approval of validation deliverables
- Test scripts based on risk level
- Utilize universal test cases where possible
- Test standard objects once and verify correct implementation
MES Implementation Strategy
Parallel Workstreams
- Development of Master Recipes in Parallel
- Workshops used to bring entire team together to confirm requirements, review design solution, finalize solution and perform final review
Data Contextualization
Use a preferred Third Party server interface software to visualize data.
Equipment Integration
Achieve a single source of truth with production equipment and assets.
MES/DCS Integration
Shorten the production introduction burden and technical transfer time.
Order Scheduling
Release production orders as needed, as a function of predictive scheduling.
Product Specific Data Management
Automatically transfer product specific data into recipes and sequence of functions.
