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Meet
all quality objectives and applicable regulatory
requirements |
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Design
and operate laboratories to ensure quality and
compliance with applicable regulatory requirements
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Maintain
GLP and other skills impacting quality through
internal training programs |
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Conduct
internal or host customer and regulatory body
audits to demonstrate and ensure quality and compliance |
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Document
the Simbiosys' quality systems, audits and performance
including validation, materials control (receipt,
handling and shipping of reagents, equipment
and supplies), specifications, processing procedures
inclusive of master and batch records, test
methods, and vendor and supplier approval processes
and practices
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Investigate
all out-of-specification events, deviations
and discrepancies, report the findings and conclusions
of the investigation, and implement and document
corrective and preventive actions
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Maintain
preventative maintenance and calibration programs
to ensure validated systems are appropriately
maintained and operating as defined
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Measure
and report quality data and seek ways to continually
improve performance
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| Quality
measures for Assays : |
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Positive
and negative controls included on each assay plate |
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8-12
point standard reference curves included with
each assay run. IC50/Ki values determined for
reference compound using qualified stocks and
compared to mother stock to validate the assay
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Data
generated at Simbiosys laboratories are subject
to 4-level review by: |
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Replicate
Analysis: Replicates are analyzed for
standard deviations. Replicates with >
15% CV (coefficient of variation) are
flagged
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Quality
manager responsible reviews data from
each plate to compare plate-to-plate consistency
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Platform
Manager
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R&D
Director
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QoS
statements are included with the final client
report confirming that the data presented
have been reviewed and meet Simbiosys' quality
standards.
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