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The ALTA Quality Assurance Program, under the
direction of Lynn Heiman
, has been implemented to ensure the ultimate in data quality and integrity
in strict accordance with FDA Good Laboratory Practice Standards.
-
Routine internal audits and inspections
Routine internal audits and inspections are
performed to assure facilities, equipment, personnel, methods,
practices, records, and controls are in conformance with GLP.
- Study Inspections
As part of GLP compliance, studies conducted under protocol are
inspected during various critical phases to ensure study integrity.
In addition, data audits are conducted for adherence to study
specific QC requirements, including precision and accuracy
control limits.
- Data Audits
Alta's quality assurance program has been designed to control data
quality at the source of production. Each record (data component) is
reviewed in process by the appropriate staff, preferably the analyst
or project manager receiving the data. Alta relies heavily on
"semi-automation" where critical data intensive events
have been automated to reduce transcription errors and improve
result tracking and compilation. All study data, notebooks, and
files are reviewed to assure compliance to protocols, laboratory
SOPs and to GLP. Final reports are reviewed to assure that the
report accurately reflects the raw data, describes the experimental
method, data results and observations. Upon final review, the
Quality Assurance Unit (QAU) prepares and signs a Statement of
Quality Assurance to be included with the final report.
- Records Management
The organization of study files, archives, and other key record
keeping procedures have been co-designed by the QAU, project
managers, and management. At the close of a study, all raw data or
exact copies thereof, protocols, and copies of final reports are
retained in a locked fireproof cabinet in a specifically designated
archive room. Access to the archives is limited to authorized
personnel.
- Training
Alta provides ongoing training in the application of
Good Laboratory Practice Standards. All laboratory personnel receive
an introduction to GLPs and laboratory SOPs from Alta's QAU. In
addition, each employee will attend a GLP basic training seminar
from a third party. Training records are maintained by the QAU for
every laboratory employee performing technical procedures and
recording data.
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