Pharmaceuticals
Compliancy, consistent quality and streamlined manufacturing and documentation processes
are crucial to the success of Pharmaceutical manufacturers. This is even more important
in today's aggressive environment due to pressure from regulatory agencies, consolidated
buying groups, and low cost generics manufacturers. Camstar InSite
is an integrated Manufacturing Execution and Quality solution that enables companies
to gain unprecedented quality and operational benefits, leading to improved profitability
and regulatory compliance.
ENABLES MAXIMUM ROI FOR THE ENTIRE ENTERPRISE
For over 18 years Camstar has implemented its robust InSite MES to provide significant
value to companies around the world. Companies can quickly implement the solution
across multiple global locations, leading to streamlined processes, improved overall
compliance, and improved manufacturing operations.
By standardizing on the InSite MES, multi-plant pharmaceutical manufacturers can:
- Improve overall product quality
InSite helps pharmaceutical companies ensure that the processes are executed in
the exact same fashion that they are designed. InSite ensures that current work
instructions are always at the fingertips of the operators that execute them. Furthermore,
only trained operators are able to execute pre-determined operations which ensure
that no non-conformances occur due to lack of training. These capabilities are incredibly
scalable, thus ensuring optimal product quality regardless of plant size.
- Ensure quality with complete traceability
To create electronic batch records (eBR), InSite collects all manufacturing information
including: operators, equipment, date and time, process used, and quality data.
InSite also applies statistical process control (SPC) with alerts and exception
processes to enable rapid resolution of manufacturing issues before they become
product problems. Finally, InSite enables dynamic quality management by automating
the management and enforcement of workflows and specifications, thus reducing manufacturing
variability across facilities while improving quality throughout the global production
network.
- Simplify and reduce cost of regulatory compliance
InSite includes functionality specifically designed to help pharmaceutical manufacturers
quickly and accurately comply with current and emerging regulatory requirements,
reducing the cost of compliance while improving efficiency and providing full accountability.
InSite complies with FDA Title 21 CFR Part 11 governing electronic signatures and
the collection and storage of electronic records. And timely as-built history and
genealogy functionality ensures the integrity of the manufacturing audit trail by
accurately tracking material and production activities across different sites, time
zones, and geographies - all in support of current good manufacturing practice(210/211).
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