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As a heavily
regulated industry, Compliance is an ongoing
priority for pharma. Systems and
business processes need to comply to
government regulations, and pharma staff
need to comply with SOPs. 3C Company can
help ensure your compliance with years of
experience in validation & remediation of
systems as well as developing new systems to
monitor ongoing staff compliance with SOPs.
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21 CFR Part 11 Validation
Validation & Remediation
for compliance of a legacy Clinical
Trial Management System deployed worldwide
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Compliance Tracking
In a regulated
environment, SOP compliance is always an issue,
and this large pharmaceutical company was no
exception. It had recently come to light that
study monitors were experiencing difficulty in
producing approved site visit reports in a
timeframe and with the frequency called for by the
Standard Operating Procedures. 3C Company was
challenged with developing a system for scheduling
investigative site visits, and tracking the
subsequent draft and approval of trip reports.
This system works closely in concert with the CTMS
to minimize any additional steps for the study
monitor. Today the internal compliance team uses
the data in this system to ensure a uniform high
level of quality and timeliness of the site visit
reports.
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