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Quality
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Compliance and Validation
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ONG Automation Ltd has extensive experience over the last 25 years, working for
many Pharmaceutical and Medical Device, Food & Beverage, Business sectors.
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Compliance:
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Applying compliance to FDA, GMP's and GAMP5 requirements ONG can assure our customers
that we are the ideal partner for working in a Regulatory environment.
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ONG Quality Systems are designed to be simple yet effective from Design Concept
to finished product and we provide excellent Quality Engineering based on the ISO
9001 standard & GAMP5 for all projects.
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ISO9001 is used in conjunction with the Gamp 5 Life Cycle Model to ensure key projects
follow the best Industry standards and practices. ONG provides for project documentation
from FDS,FAT,HDS,SAT following a dedicated life cycle.
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Validation:
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ONG can provide validation support services to complement customers IQ,OQ,PQ, process
stages inclusive of site support engineers to ensure compliance is maintained to
suit the customer requirements. This wealth of knowledge and experience means we
have the necessary expertise to help you comply with regulatory demands.
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Validation Services:
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ONG Automation Ltd, provides Design and Validation Services utilizing significant
experience and training. From Customer Design Qualification Protocols of Automation
Systems, to IO/OQ and PQ Qualifications. ONG Automation services provides for Manufacturing
Processes for Pharmaceutical, Medical Device & Diagnostic, Food and Beverage, Consumer
Products Industries.
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Validating automation and control systems such as PLCs, SCADA (Supervisory Control
and Data Acquisition), requires an in-depth technical knowledge of the systems along
with validation expertise. Our teams are degree qualified Engineers with extensive
experience. ONG Engineers have the experience and skills needed to validate complex
systems and at the same time ensure compliance to regulatory requirements maintaining
a state of validation.
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