 POMS
MES for Biologics
Management of Biologics Manufacturing
Operations
Honeywell’s POMS MES for Biologics solution is
a manufacturing execution system (MES) that manages
the production operations of FDA-regulated biologics
companies at every step of the process—from materials
receipt to the finished goods warehouse.
POMS MES is one of the most widely used and validated
MES systems in the Food and Drug Administration (FDA)-regulated
industries, with unparalleled power and breadth of functionality.
Implementations of POMS have been inspected and accepted
by the FDA and other national regulatory agencies worldwide.
POMS MES for Biologics ensures your manufacturing operations
are capable of delivering on your enterprise’s
e-business supply chain commitments. Your complex biologics
processes are managed at lower costs, and in shorter
timeframes, while meeting regulatory requirements.
POMS MES BENEFITS
• Reduced migration time of biologics processes
from R&D to manufacturing
• Consistent execution of biologics processes
• Streamlined validation efforts
• Increased schedule attainment
• Manufacturing flexibility while maintaining
execution discipline
• Recipe integration to PLC/DCS and batch historians
required for Biologics
• Comprehensive EBR (electronic batch record)
for Biologics
Key Activities Addressed by POMS MES for
Biologics
Process Modeling and Specification via
eSpec™
POMS MES for Biologics depends
on the award winning POMS eSpec™ for process modeling
and specification management. No other specification
product exists equal to the rich functionality of POMS
eSpec™. This S88 compliant tool enables creation
of process structures identifying the processes in terms
of operations and phases. The relationships of the operations
and phases are further refined using elements and attributes.
POMS eSpec™ is implemented during initial R&D
activity, through process qualification and finally
manufacturing scale-up; capturing specifications and
key critical parameters associated with the biologics
process. The resultant POMS eSpec™ execution instructions
are used to initiate and execute all biologics process
and control systems activities modeled during R&D,
qualification and scale-up cycles.
Advantages:
• Designed for the Process Specialist or Process
Authority
• Comprehensive Process Definition and Specifications
• Process Modeling Basis
• Reusable process operation and phase components
• Version and Revision control
• Integration to PLC/DCS for operation and phases
execution.
Comprehensive Management
From creating master batch records for products, to
consistently executing manufacturing processes, to measuring
plant productivity—POMS MES for Biologics offers
a total integrated solution.
Using eSpec™ developed specifications and interactive
instructions, POMS MES provides the ability to view,
control and manage all aspects of production on the
plant floor, including materials, labels, work-in-process,
assets, control systems, work instructions, facilities,
labor and documentation. POMS MES addresses every step
of the manufacturing process—from initial receipt
of raw materials through weighing/dispensing, solution
preparation, cell culture, fermentation, purification,
recovery and packaging activities. By guiding operators
and equipment through the manufacturing process with
interactive, step-by-step dialog; POMS MES ensures your
products are manufactured and packaged consistently,
within specifications, according to validation constraints
with the lowest possible cost.
Please continue to MES for Biologics Page 2 >
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