Does the data gulf between CMOs and
CROs and their customers need to exist?
Product companies and CMO/CRO (contract
manufacturing/research organization) organizations we
have met have expressed a
desire to have
easier access to process, manufacturing, and quality data for themselves and
for their customers continuous process verification. CMO’s have time consuming
and expensive task of using difficult to access data for process monitoring,
troubleshooting and investigations, annual product reviews and responding to
customer needs. For their customers, a
large gulf exists between them and their process data due to the difficulty
retrieving their data from batch records and the CMO’s production systems. This
results in time
consuming manual efforts, errors, rework, cost escalation,
potential supply chain and quality or compliance problems, and
project delays. Needless
to say, all of these things can damage the relationship between CMOs and their
customers.
Fortunately, technology advances have
removed these barriers so that these data gulfs no longer need to exist for any
organization. One such platform is ProcessPadTM, the first browser based process
and quality data platform in the industry. ProcessPadTM
platform enables CMOs to share both their manually entered process data from
paper or electronic batch manufacturing records and streaming machine data. ProcessPadTM is fully 21CFR Part 11 compliant
software that
can be hosted by the CMO/CRO hosted on a validated cloud.
How product companies can
utilize the platform?
Sponsors’ can subscribe to a dedicated
data portal on the
ProcessPad platform
to access
their CMO and CRO
data. By running standard and ad hoc reports, they can easily visualize and
monitor their process performance based on customized alert and action limit
criteria. They can also easily visualize their batch production history using
color-coded tags and easily generate lot genealogy trees along with many other
capabilities.
How CMOs can utilize the platform?
If the sponsor organization don’t have a
portal on the ProcessPad platform the CMO organization can also subscribe to a
dedicated data portal on ProcessPad platform to monitor processing operations
of all their products and then can allow access to sponsors for specific products.
CMOs can also utilize the data portal as an additional service to the sponsor organization. CMO/CROs
can also use the platform to enhance the efficiency, reliability, and
profitability of their operations. One common arena where this can occur is
compiling and trending data for annual product quality reviews through
automated reports for customers.
Both sponsors and CMO can now host all their
process data (offline batch record data as well as streaming machine data) on
the ProcessPadTM platform. For more information write to us at info@simplyfeye.com or info@windshire.org
Founded in 2010, Simplyfeye Softwares Private Ltd.
provides data analytic products and solutions to life science processing
companies. Its ProcessPadTM software enables these organizations to
maximize the value of their quality metric, process, QC and manufacturing data
throughout the product lifecycle. Simplyfeye is partnered with The Windshire
Group, LLC for marketing and servicing ProcessPad in the Americas.
ProcessPadTM uses a browser interface to
provide easy on-demand access, across functions and with suppliers, to data for
aggregation, management, visualization, and analysis. Organizations benefit
from more efficient use of human resources; process improvements and higher
manufacturing yields; more robust investigations and troubleshooting; higher
product quality; and better regulatory compliance.
© Simplyfeye Softwares | info@simplyfeye.com | http://www.simplyfeye.com
