corporate
 
 

QoS is in the DNA of how we conduct business. We understand the importance of providing data of the highest quality and have adopted strict quality control measures. Our scientists and technical teams interact directly with clients to understand their specific quality requirements. Simbiosys' quality and regulatory affairs personnel oversee conformance with customer, FDA and other applicable international regulatory agencies. The majority of our discovery services programs can be easily transitioned to follow Good Laboratory Practices (GLP).

Simbiosys will constantly strive to:

Meet all quality objectives and applicable regulatory requirements
 

Design and operate laboratories to ensure quality and compliance with applicable regulatory requirements

Maintain GLP and other skills impacting quality through internal training programs
 
Conduct internal or host customer and regulatory body audits to demonstrate and ensure quality and compliance
 

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

 

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

 

Maintain preventative maintenance and calibration programs to ensure validated systems are appropriately maintained and operating as defined

 

Measure and report quality data and seek ways to continually improve performance

   
Quality measures for Assays :
Positive and negative controls included on each assay plate
 

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

Data generated at Simbiosys laboratories are subject to 4-level review by:
 
 

Replicate Analysis: Replicates are analyzed for standard deviations. Replicates with > 15% CV (coefficient of variation) are flagged

 
 

Quality manager responsible reviews data from each plate to compare plate-to-plate consistency

 

Platform Manager

 

R&D Director

QoS statements are included with the final client report confirming that the data presented have been reviewed and meet Simbiosys' quality standards.

 

 
Assay Development
Cell Isolation & Banking
Cell Line Development
Natural Product Testing
Molecular Biology
Bioinfomatics

 

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