Enhanced communication with efficient real-time data sharing between Sponsors and CMO’s

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

 

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Founded in 2010, Simplyfeye Softwares Private Ltd. provides data analytic products and solutions to life science processing companies. Its ProcessPad^TM 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.

ProcessPad^TM 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.

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© Simplyfeye Softwares        |        info@simplyfeye.com        |          http://www.simplyfeye.com

Monitoring Outsourced Biomanufacturing: Sponsor/CMO Collaboration

Further to my previous post on using Excel as a recording tool, one of the advantages of using this approach is in data collection from diverse locations particularly in the outsourced manufacturing environment.

As we see more and more CMO activites proliferating (with drug discovery and commercialization companies sponsoring/outsourcing their manufacturing to CMO's providing in clinical and commercial manufacturing services), there arise a need for better collaboration and continuous communication (almost in the real-time mode) between both the parties. With easy to configure Excel based process templates sponsor organizations can easily collect process data from their CMO counterparts in a near real time manner. Since most of the CMO's prefer to work on a paper based recording system as its practically unviable for them to invest in electronic batch recording system owing to multi-product nature of their business and constant changes in their product manufacturing pipelines, in our view this (Excel recording) approach is most economical in an outsourced environment.

With our ProcessPad platform the sponsors can provide a secure way of uploading the process data where both parties can have real time access to same process information. Sponsors can easily control the access to the system. A schematic of such a system is shown below:

Write to us if your organization is involved in outsourcing activity/services and you are looking for effective solutions for sharing and collaborating with your sponsors or CMO's.