Integrated
Quality Management Software System
EtQ's GMP Compliance Software for Medical Device is an
integrated quality management and FDA compliance software system that has been
pre-configured to specifically
address the needs of the Medical
Device industry, and exceed GMP standards and 21
CFR Part 11 compliance requirements.
EtQ's unique modular approach
provides unparalleled flexibility
and automation. These 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 Nonconformance Management Software and Customer Complaints/Complaint Handling Software 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 Management 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
Management Software module
• Initial
assessment to allow early closure
• Risk
Management 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
Closed-Loop
CAPA
EtQ's GMP Compliance Software for Medical Device is pre-configured to initiate
various post-CAPA processes, including
electronic distribution of CAPA results, Change
Management, and Employee
Training.
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
Quality Management System Methodology for
Medical Device
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 Medical Device
industry:
