Data Sheet
MasterControl Documents
True document control is a must in a regulated
industry, but it’s hard to achieve without a digital
system. MasterControl Documents, an integral
part of MasterControl Quality Excellence, eliminates
uncontrolled copies, automatically archives out-ofdate documents, and is easily searchable during
inspections and audits.
Quality Excellence
Transform quality management
with the most complete,
connected, and intelligent QMS
available today. Choose the
proven platform that empowers
you to digitize and automate the
management of quality events,
documents and training across
your entire product life cycle —
and get your products to
market sooner.
Key Benefits
1
No Uncontrolled Copies
Restrict editing rights on documents and automatically archive old
versions of a document when it’s updated. You can also use timebombs
on downloaded PDF documents to ensure they will only be used up to
a certain time and date.
2
Automatically Organize Documents
Organize documents by setting up rules to automatically group them
based on metadata.
3
MasterControl Training Integration
When documents are updated, MasterControl automatically sends
out training tasks to affected employees. All associated training
information is tracked and compiled in training folders.
Data Sheet
Our 510(k)
submission was
smooth because we
had all the documents
in MasterControl.
All I had to do was
make an e-copy to
send to the reviewer,
and then to the FDA.
It was a fairly
simple process.”
A Closer Look at Features
– VP of Quality and Regulatory
Affairs, Medical Device Company
MasterControl Insights
Turn static, siloed information
into actionable intelligence.
Transform product development
with dynamic data management
and exploration through
powerful, personalized reporting
and dashboards.
1
Embedded Change Control
Eliminate unnecessary draft revisions by embedding change control
into workflows. When initiating a revision, MasterControl will require
the reason for change and change description, creating the draft
revision only when approved by appropriate individuals. Every change
is recorded with the person who made it, when it was made, and the
reason for the change captured for each revision.
2
Virtual Collaboration
Exchange comments back and forth online, removing the need for
in-person meetings. Avoid bottlenecks by automating escalation and
allowing alternative approvals when employees are out of the office.
3
Audit-Ready Documentation
All documentation is in the same, easily searchable location. Users
can easily provide documentation to auditors or allow auditors to have
limited access to select documents in the system.
Unlock the Power of Your Data
Every cloud instance of MasterControl includes MasterControl Insights. Insights
is an interactive business intelligence and data management tool that gives you
complete access to your data. Pre-configured, role-based dashboard visualizations
give you a comprehensive view of quality and manufacturing processes.
Additional Insights Features:
•
Customized dashboards to meet your business needs
•
Robust reporting
•
Advanced analytics and artificial intelligence (AI) capabilities
•
Export application programming interface (API)
•
Key performance indicator (KPI) management
About MasterControl
MasterControl Inc. is a leading provider of cloud-based quality, compliance and
production management software for life sciences and other regulated industries.
Our mission is the same as that of our customers – to bring life-changing products to more
people sooner. The MasterControl Platform helps organizations digitize, automate
and connect critical processes across the regulated product development life cycle.
Learn more at mastercontrol.com
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