Quality Systems
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Quality clinical research demands standardisation of procedures which can only be
achieved through Quality Assurance (QA) and Quality Control (QC) systems.
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SOPs and study-specific documentation
Implementation and maintenance of QA and QC systems with written
Standard Operating Procedures (SOPs) and detailed written study-specific
guidelines ensures that clinical studies are conducted and data are
generated, documented, reported and archived in a consistent manner and
according to GCP and other applicable regulatory requirements.
SOPs are written statements of the quality procedures of a company.
SOCAR has an extensive set of SOPs which are updated regularly to
improve quality and to ensure that they reflect all relevant local and
international regulatory requirements. For each study, SOCAR develops
study-specific guidelines that document the QC checks to be applied
to each stage of data handling and processing. Study-specific guidelines
ensure that data handling and processing occur in a consistent manner and
that all data are complete, consistent and plausible and have been
processed and coded correctly.
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Computer validation
It is SOCAR’s policy to work with validated computer systems.
Prior to implementation, each study-specific database is validated
according to well-documented procedures to ensure that it
complies with ICH-GCP guidelines and FDA 21CFR Part 11.
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Training
Training is performed on an on-going basis and adjusted according to personal
development needs and job requirements. All training is documented on
training records.
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