Reaping Benefits Through Enhanced
e-Management and Analytics
Spreading 2018 success by shredding
the 20th century spreadsheet.
By Mike Botta, Executive Editor
As the pharmaceutical industry wrestles with evolving regulations, technical challenges, and mounting pressures to reduce prescription drug prices,
manufacturers continue to search for new ways
to streamline operations and reduce costs, while
increasing quality, safety, and speed to market.
To that end, one major provider of software
services to the life sciences sector has introduced
a new analytics engine and three new cloud-based
applications designed to help pharmaceutical
management increase efficiencies, enhance quality
controls, and improve business processes.
Salt Lake City-based MasterControl Inc. recently
released version 11. 7 of its quality management
system, an upgraded package featuring enhanced
analytics capabilities and three new cloud-based
offerings: eTMF Manager; Registrations; and
Registrations for eCTD.
The eTMF—or electronic trial master file—
software system automates, centralizes, and
standardizes the TMF process thus minimizing
the burden, risk, and complexity of managing
vast amounts of clinical trial data. Without
eTMF, managing thousands of documents and
massive amounts of data using paper-based or
hybrid systems can lead to errors and oversights
that potentially place clinical trials at risk of
Registrations software manages product
registration and 510(k) device submissions,
automates manual or hybrid processes, and tracks
the various requirements for every geographic
location, creating transparency for effective
monitoring of submission bottlenecks.
Registrations eCTD—or Electronic Common
Technical Document standard—publishing
software allows users to quickly identify content
based on region and prepare for electronic
submission publishing via a partner in in-house
publishing tool. eCTD has been adopted by many
countries in order to standardize registration
information, eliminating differing regional and
other requirements across the various geographical
When it comes to product registration, many
life sciences companies are not selling just into
the U.S., but selling into a hundred or more
geographical locations around the globe, Matt
Lowe, executive VP of MasterControl, told
Pharmaceutical Processing in a recent interview.
No doubt, tracking the regulatory requirements
for a 1,000 different products heading into 100
different countries becomes a daunting task and
regulatory affairs folks have been managing the
process largely on Excel spreadsheets for years.
“For that many products in that many markets
the spreadsheet is up to date for about the five