Simplyfeye Official Blog

Wednesday, April 27, 2016

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

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.

Sunday, February 7, 2016

Introducing Drug Stability Data Management and Advanced Statistical Engine in ProcessPad

Stability Data Capture: Formulations of Intermediate, Drug Substance, and Final Drug Product

Testing for stability and trending for shelf life prediction is an important activity of engineers and scientists involved in pharmaceutical or biologics drug development and manufacturing. With the addition of a stability module within ProcessPad^TM platform, scientists can now perform this important aspect of process data management and analysis without the need of exiting (or exporting the data) to an external system. Within ProcessPad’s existing process sample test data management capability, we have extended the capability of the software to capture and trend drug stability data. We have made minimal changes to our existing test/assay data capture format to ensure no additional training for lab and QA personnel entering, verifying, and approving data.

The stability management console supports specification limits management for each marketing region and tracks both quantitative and qualitative specifications. Users can flag protocol events/addendums or method changes for better correlation of data and quick compilation of protocol data, events, or addendums throughout the entire life-cycle of the protocol execution.

Shelf-life Prediction: ProcessPad^TM advanced statistical engine

ProcessPad^TM platform now comes embedded with an advanced statistics engine for predicting shelf-life for long term storage condition. All the shelf-life prediction models designed for poolability of batches conforms to statistical approaches mentioned in ICH-Q1E (Appendix B2.2).

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 WindshireGroup, LLC for marketing and servicing ProcessPad^TM in the Americas.

Friday, January 1, 2016

Launching ProcessPad version 2.0

Happy new year 2016!

At the start of this new year 2016 we at Simplyfeye are excited to launch our new and improved version 2.0 of ProcessPad which is even more responsive and user friendly than our earlier versions. Our product development team has been constantly tracking feedback from our users and has responded with incorporating many of the suggestions into this new version.

Improved Data Selection and Navigation: We have added new search features and color based segregation to help users to easily navigate to the desired process data sets for easier data preparation/selection.

Improved Data Outputs: All tabular outputs are standardized to give users (only who have authorization) to easily copy, print or generate tabular PDF reports from any table within the application. All tables now comes with text search capabilities.

Better Chart Controls: Users now has better controls over their charts where axis scales and axis labels can be customized for all standard charts within the application. All customized charts can be saved into adhoc reports for sharing and discussion.

We continually strive to bring quality products to the biotechnology and pharmaceutical user community. We also strive to help in their constant endeavors into process knowledge management and to seek better understanding of their commercial manufacturing processes via our products and solutions.

About ProcessPad

ProcessPad is biologics and pharma process management software to manage process data in development and commercial manufacturing of biopharmaceuticals.

Wednesday, December 9, 2015

Non-conformances or Process Discrepancies: Efficient investigations for root-cause and effective CAPAs

Investigations usually need to ask common questions every time an event occurs to get to the “Why” (root cause and contributing factors) of the event and find effective CAPA’s to prevent recurrence.

Typical questions asked by all investigators are:

What is the event? (and equally important is to understand is the “what is not the event?” to define the scope of investigation): This makes availability of all contextual information very important at the fingertips of the investigator. The delay in access to information leads to delay problem understanding and hence delay in scoping leading to delay in root-cause/CAPA identification.
When did the event occurred? : Instant access to accurate time frame of the event and all associated event window is extremely important.
How did the event occurred? : Access to batch profiles helps to identify and trace the event trajectory
What is the impact of the event? Has it occurred before? How severely? Were other systems impacted? Site? Products? An initial impact assessment needs to be made to determine the scope of the investigation. Only when the root cause is determined, can final impact be determined.
Why did the event occurred? : ability to correlate parameters across the process can help identify why those events could have occurred
Is there a precedence? : has the event occurred before in past manufacturing history. What was the root-cause and CAPA identified. Why was CAPA not effective?
How far is the event from set target? : what is the severity of deviation and how far is it from control limits? When was the last time the limits were revised? Is the event closer to older limits?
What is the organizations’ benchmark? : Can I compare this event with similar events in other process steps within the process or across processes/products. Access to this information will help in setting effective CAPA

In most cases currently investigators spend majority of their time hunting for gathering information rather than seek answers to these routine questions that could lead to better quality of root-cause and CAPA solutions. Tools that can readily answer these questions on a readymade basis will tremendously help organizations to be more productive, proactive, economical and avoid repeated failures with ineffective CAPA.

The graphic below shows how adoption of ProcessPad help organizations get instant access to all the relevant information to seek answers to questions above.

Dr. James Blackwell, President, Founder, and Principal Consultant of The Windshire Group (a consultancy providing global CMC- chemistry manufacturing controls consulting services to life science and allied regulated industries www.windshire.org) , LLC agrees: “I’ve said many times in my career that the biggest problem I had was getting the data I needed to solve problems or make process improvements. As the industry’s first web based solution, ProcessPad is a huge advance that helps organizations maintain control of their processes, improve supply chain efficiency and consistency, and remain compliant.”

ProcessPad is built ground up by pharma and biotech professionals for continued process verification and process monitoring. Continuous trending and monitoring on a proactive and real-time basis can prevent some of these problems to occur and standardized reporting across the organization can save tremendous time performing investigations.

About ProcessPad(TM)

ProcessPad(TM) is bio+pharma process management software to manage process data in development and commercial manufacturing of biopharmaceuticals.

Saturday, November 14, 2015

How ProcessPad is impacting our customers' internal work processes?

Many times our potential customers are willing to try new technologies or solutions but are hesitant in doing so and leans more towards traditional known names/solutions or choosing not to have any solution at all. We primarily owe this to their prior experience:

with bad products
with apprehensions about poor user adaptability and adopt-ability
with inflexibility of systems that cannot blend easily with local floor level work processes

Since Simplyfeye is a new company with our new process data management platform ProcessPad, from the onset we keep a close eye on the usability of our software deep within the customer organisation. Like any other enterprise related B2B sales people who made the buying decision are mostly not the end users. This makes it very hard to get correct user feedback and assess the level of engagement, impact and traction that our tool is getting via assimilation with organizations' internal work processes. However, we are really glad to present a nice graphic below which we created after our deep engagements with one of our customer (at all levels of the customer organization) and understanding the impact ProcessPad is having in their internal work processes.

The graphic shows the key work processes within each core work function where ProcessPad is having a positive impact after its introduction into the organization. We are really happy to learn that it has been utilized and appreciated by all core work functions within the biopharmaceutical organization and have been used in ways that we never intended it to be utilized initially (we originally designed the system focusing primarily on Process Monitoring and Continued Process Verification). Simplyfeye team strives to continually evolve the ProcessPad platform with the help these continuous customer engagements.

Saturday, August 29, 2015

Continuous Process Verification (What it takes for a rapid set up?)

ICH Q10 Guidance and Process Validation Guidance published by FDA in 2011 both emphasizes routine process monitoring and continued process verification (CPV) as an integral part and a third and final stage of process validation and its life-cycle management.

A nice and very detailed case study has been published by BPOG (Biophorum Operations Group) on how to implement CPV. Though this case study is very detailed, here below is summarized in a flow chart the steps involved in setting up CPV. This gives an idea of what procedures, tools and efforts needed to rapidly setup a CPV program at your organization.

For definitions of CPP, KPP and MP refer to our July 27, 2015 blog on SPC.

Steps 1 through 4 involves scientific judgement hence cannot be automated. This will involve some initial lag time to establish a CPV program. However an efficient knowledge management platform can greatly help in rapidly identifying parameters to monitor and establishing trending techniques and can significantly help in reducing time of deployment.

Steps 5 through 11 require fair amount of labor and can become a daunting task to routinely monitor hundreds of parameters (especially for complex biologic products), investigate trends and keep updating/adjusting the control limits to keep a check on process variability and capability. Adding to this if your site/organization is a multi product commercial manufacturing site this activity become impossible to perform manually and keep up the frequent reviews of processes with limited resources (FTE's) available. Most of the steps from Steps 5 through 11 can easily be automated and a specially designed software tool for CPV purpose can prove to be great advantage having capabilities in terms of:

data integration and warehousing of all relevant historical process information
lot traceability and genealogy
performing correlations across process steps for quick troubleshooting
overlaying batch trends
templating specific process parameters for routine periodic trending
historical limits management
validated reporting

Few tools in this space have emerged recently (in last few years) catering to process data management and particularly CPV.

Our ProcessPad platform is industry first completely web-based bioprocess data management software for rapidly deploying CPV in your organization. Contact us for more information at info@simplyfeye.com.

More about us at: http://www.simplyfeye.com

Wednesday, August 12, 2015

Simplyfeye at ISPE Boston Product Show (October 7, 2015)

Easy | Intuitive | Collaborative | Part11 Compliant

Visit our booth at the upcoming ISPE Boston Product Show and know more about our product ProcessPad.

Event Details:
Booth # 2214
ISPE Product Show XXIV
Wednesday October 7, 2015
Gillette Stadium Clubhouse
Foxborough, MA

More Details about the event at: http://productshow.ispeboston.org/