Integrated
FDA Compliance Software System
EtQ Pharmaceuticals/Biotechnology
is an integrated FDA Compliance
Management System that has been
pre-configured to specifically
address the needs of the Pharmaceuticals/Biotechnology
industry, and exceed 21 CFR part
11 requirements. EtQ's unique
modular approach provides unparalleled
flexibility and automation. The
modules
are tightly integrated to deliver
a best-in-class FDA
Compliance Software solution.
Connected
to the Production Systems
EtQ Connectors close the gap between
production systems and the quality
system. Modules
like nonconforming
materials and Adverse
Event Handling connect to
ERP and CRM systems to fully automate
the creation and assignment of
events. Production systems can
then be automatically updated
throughout the event resolution
process. For example, to trigger
the release of product based on
the MRB disposition; or update
the complaint status based on
the CAPA investigation results.
Advanced
Filtering of Events
EtQ's unique FDA
Compliance Software System
is designed to minimize the number
of CAPAs using an advanced filtering
model:
• Automatic segregation
and categorization of events at
the source
• Automatic identification
and display of related events
• Built-in Risk
Assessment Software module
• Initial
assessment to allow early closure
• Risk
Assessment throughout the
process to guide decision making • Full investigation
with step-by-step root cause analysis
• Automatic lookup
and display of related investigations
and CAPAs • Comprehensive
CAPA action and effectiveness
check plan with risk mitigation
history
eValidation
EtQ offers an automated validation
module that will shorten the validation
process from weeks to minutes.
EtQ's unique eValidator™
comes preloaded OQs and PQs for
all the pre-configured modules. Read
More on eValidation >>
Electronic
Submissions to the FDA (eMDR)
EtQ Reliance eMDR Submission Tool
enables Medical Device Manufacturers
to electronically submit Medical
Device Reports (MDRs) to the Food
and Drug Administration (FDA).
This methodology allows companies
to electronically automate the
quality process for medical device,
and comply with quality and compliance
standards, including those of
the FDA. Read
More on eMDR>>
Advanced
FDA Compliance Methodology for Pharmaceuticals/Biotechnology
Implementing different Quality
Management applications to FDA Compliance
is costly, time-consuming and confusing to
users. With all its functionality built around
a common platform, EtQ has developed a
Management System that unifies both quality and
FDA compliance processes in the Pharmaceuticals/Biotechnology
industry:
