QUALITY ASSURANCE AND REGULATORY COMPLIANCE
NorthEast Bioanalytical Laboratories
has optimized its processes and workflow strategies to maximize
efficiency at all stages of project conduct. All work performance
from receipt of study samples to reporting of data and completion of
study reports is based on a comprehensive set of standard operating
procedures that comply with FDA Good Laboratory Practice regulations.
For regulated studies, Quality Assurance staff ensure that all
work has been performed in strict compliance with internal policies and
procedures. Other salient features of our organization include:
• Complete inventory of study samples upon receipt noting any
abnormalities in the condition of the samples. The samples are
then stored according to the client's specifications in a secure
environment with constant temperature monitoring. The outcome of
the inventory is then conveyed to the client.
• All bioanalytical methods are fully validated and approved
before initiating sample analysis. Validations include a
thorough assessment of analyte stability prior to sample handling to
ensure complete integrity of the resulting study data. Results
are reviewed from a scientific perspective allowing NEBA staff to
provide clients with valuable feedback in the outcome of the study.
• Study reports are provided in hard copy and electronic formats
in our standardized format, or the reports can be customized according to client
specifications.
• All equipment is maintained and recertified on a routine basis.
• Training records for all personnel are maintained and updated regularly.
• Appropriate safety procedures are in place with periodic safety meetings being conducted with all staff.
• Biohazardous and toxic waste disposal is handled by authorized contract services.
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