by implementing MES best practices
MES Starter Kits
Reduce risk and speed up time to production with an out-of-the-box approach to MES implementation.
Reduce risk and speed up time to production with an out-of-the-box approach to MES implementation.
Starter kits draw on proven best practices, enabling you to minimize risk to project scope and schedule. The starter kits allow you to transform your manufacturing process into automated workflows with minimum risk using standardized MES objects.
Out-of-the-box components accelerate project delivery using proven manufacturing processes and help you achieve 21 CFR Part 11 and Annex 11 compliance. By applying the Starter Kit methodology, you implement industry best practices to achieve results faster, with less risk and fewer scope changes.
Starter kits are designed to meet 80% of your project needs. Using the standards, guidelines, and configurable recipe objects provided, you can easily adopt and implement the out-of-the-box functionality to suit your manufacturing process.
by implementing MES best practices
with faster project delivery
using out-of-the-box functionality
Starter kits are delivered with an easy-to-use installer. After installation wizard windows, you have a fully-functioning electronic batch record (EBR) solution template. The solution includes parameterized recipe objects, sample equipment and materials, and documentation.
Documented process flows provide a solid foundation for implementation success. Business process flow diagrams detail the manufacturing process and facilitate project design discussions from gap analysis through project kickoff, execution, and implementation.
Starter kit recipes can be executed during the FEED as workflows. These workflows have the depth and breadth needed to guide the project team through the complete, pre-configured solution. Workflows parameterize components of the implementation, enabling a more streamlined configuration.
With an out-of-the-box EBR solution relative to your manufacturing process, MES implementation time and risk are reduced.
The oral solid dose starter kit includes recipes covering granulation, both wet and dry, as well as solution preparation, compression, and coating.
The full biotechnology kit includes recipes covering solution prep, upstream, and downstream processing, as well as common production support objects.
Reduce release cycle time, while improving the accuracy and consistency of your batch records Electronic Batch Records ensures operators deliver in line with your process requirements, making every operator your best operator.
