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Quality
at Pleiad
Pleiad's
Quality System comprises a comprehensive set of
standard operating procedures (SOPs) and working
practice documents (WPDs), and a robust staff
training program.
Quality
is constantly reviewed and improved:
-
monthly Quality Review Meetings at which the
senior management team reviews quality metrics
(such as query rate) from all ongoing projects
and any ongoing CAPAs from internal or external
audits;
-
co-monitoring visits by clinical managers for
all projects that involve monitoring;
- lessons
learned at the end of each project;
-
dissemination of any audit results throughout
the whole company;
- internal
audits that ensure that every aspect of every
project is scrutinized by a trained quality
auditor and CAPAs are instituted as required;
- independent
process audit of Pleiad on an annual basis and
institution of any CAPAs identified;
- Quality
Management Plans for major projects;
-
Quality Improvement sessions with all departments
on a regular basis.
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