Bio4C ProcessPad™ Software
Easily Acquire, Aggregate, and Analyze Bioprocessing Data

Bio4C ProcessPad's™ data collection, visualization, and analytics enable bioprocess lifecycle management reporting, investigations, and continued process verification. Here are some examples of the value Bio4C ProcessPad™ delivers to customers using the platform:

• In the absence of a structured process data management tool, engineers and scientists spend more than 80% of their time hunting and gathering data and only 20% of their time on quality analysis. This leads to considerable delay in final corrective action. With Bio4C ProcessPad™, bioprocess scientists spend as little as 15% of their time on data capture and over 80% of their time on data analysis allowing timely corrective and preventive actions (CAPAs), the quicker release of quarantined lots under investigation, improved productivity, and better process monitoring.
• Enhanced knowledge sharing and collaboration
• Significant times savings on data aggregation and reporting. A BPOG example estimates that using an automated data management system for continued process verification (CPV) reporting across multiple sites can yield a cost savings of around 125,000 USD per year.

Bio4C ProcessPad™ facilitates 21 CFR Part 11 compliance with unique usernames and passwords, timestamped audit trails, and secure storage of all records. Software validation services as part of a Bio4C ProcessPad™ deployment are available. Read our white paper 21 CFR Part 11 Compliance Using Bio4C ProcessPad™ for details.

Bio4C ProcessPad™ features for reporting, process lifecycle management, investigations, and CPV can help biopharmaceutical manufactures meet regulatory expectations. Using an aggregated and contextualized single source of truth data, Bio4C ProcessPad™ enables good recordkeeping and knowledge transfer, supports reporting such as annual product quality reviews and process summary reports, and simplifies continued process verification.

Users can create and save templates for customized reports built with any of the data available in Bio4C ProcessPad™. Reports can be generated on-demand or scheduled on a daily, weekly, or monthly basis. Reports can easily be shared with relevant stakeholders.

Built-in Reports include:

• Process summary reports
• Annual Product Quality Reports (APQR)
• Manufacturing campaign reports
• Batch summary and runs excursion reports
• Plant equipment utilization report
• Ad hoc reports in support of root cause analysis

Bio4C ProcessPad's™ advanced data connection tool can acquire, automatically assemble complex and multidimensional data into an analysis-ready format, and analyze data from:

• Batch record data
• Quality Control results
• any standard database like SQL-Server, MySQL, and Oracle
• Enterprise Resource Planning (ERP)
• Manufacturing Execution System (MES)
• Laboratory Information Management System (LIMS)
• Data Historians
• Paper-based, manual records
• Validated spreadsheets

The batch data analytics in Bio4C ProcessPad™ specifically cater to the analysis needs of batch manufacturing processes that involve quantitative (e.g. process parameters) as well as qualitative data (e.g. events and textual information). In the design of these visualizations, the focus is given to displaying events and textual information related to a batch.

Analysis types

Lot genealogy helps investigators instantly find feed/raw materials, intermediates, or finished products corresponding to a defective lot		Overlay intra and inter batch time series data to compare batch profiles within processing times
Align unit operations on a timeline to correlate execution time context with the process event under investigation		Perform correlations and regressions on process parameters for inter or intra unit operations
Trend batch data on control charts for statistical process control to better understand process variability and to perform CPV		For inter and intra products and process analyses, create ad hoc data groups to perform statistical comparison of groups to identify significant differences

Bio4C™ ProcessPad provides 2 different applications for PCA analysis: PCA for detection of outlier batches; and multivariate data analysis (MVDA) batch progression tunnels for live monitoring of a batch.

Bio4C^™ ProcessPad’s intuitive parameter selection and data pre-processing user interface (specifically programmed for the bioprocess industry) help you build PCA models with just a few clicks, considerably reducing the time from data to insights.

Bio4C^™ ProcessPad will automatically plot the PCA charts including:

• Scores Plot: the scores of the first two principal components (PC1 and PC2) and highlights the amount of variation each principal component captures from the data 
• Loadings Plot: shows which variables has the strongest influence on a principal component
• Contributions Plot: the top 10 contributing parameters to PC1 and PC2 
• Hotelling’s T2 Plot: plots the Hotelling’s T2 statistic for all batches 
• Scree Plot: displays how much variation is captured by each principal component 

With Bio4C™ ProcessPad process engineers can create a single batch profile chart with monitoring ranges derived from PCA models created using batches which have the desired parameter values at the various stages of the manufacturing process. When plotted as a process profile for all stages, the multivariate score ranges produce a “process monitoring tunnel” that represents a single metric or control chart condensed from several parameters (key and critical process parameters) of a multistage process.

Process engineers can know not only the current state of the process for a batch in execution but also see an estimate of upcoming stages in the process. The Inter-stage MVDA batch profile allows scientists and engineers to drill down and query which parameters are currently contributing the most to the process’s state and which parameters are estimated to contribute the most in upcoming processing steps. Users can navigate to the parameter level to see the estimated values of the process parameters.

Bio4C ProcessPad™-RT module provides direct browser-based access to streaming data from process equipment for real-time machine and batch data analysis. Process engineers will have easy access to data for performing routine monitoring of batch profiles or process troubleshooting. Visualizations for machine data include:

• Golden Tunnel Live View - view the live golden tunnel dashboard
• Plant View - gives the status of equipment based on a time period
• Equipment View - visualize current trends of any equipment of interest
• Batch View - provides an overlay of parameters for various batches
• Batch Event - view all batch events with parameter profiles
• Run Reports - generate templated excursion report or ad hoc reports for a batch
• Create a Batch Event - user entry forms for creating batch events
• Pattern Match View – allows a user to match any time series pattern against historical data

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 CAPAs to prevent a recurrence.
Typical questions asked by all investigators are:

• What is the event? This question defines the scope of investigation.
• When did the event occur? An accurate time frame of the event and all associated event window is extremely important.
• How did the event occur? 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? Sites? Products? An initial impact assessment also helps to determine the scope of the investigation.
• Why did the event occur? Correlating parameters across the process can help identify why events may have occurred.
• Is there a precedence? Has the event occurred before in past manufacturing history? What were the root-cause and CAPA identified? Why was the CAPA not effective?
• How far is the event from the 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 organization's benchmark? Can comparisons be made between the current event and similar events in other process steps within the processor across processes/products?

The information sought in these questions resides in different disparate systems that are best suited for that particular workflow. Bio4C ProcessPad™ provides a single window access to all this information with relevant charts, graphs and tables to come to a root cause identification in the quickest possible manner.

With Bio4C ProcessPad's™ stability trending, scientists can test for stability and trend for shelf life prediction as part of process data management and analysis. Bio4C ProcessPad's™ stability module extends the capability of the software to capture and trend drug stability data. The stability data capture templates mimic the in-process test/assay data capture format and mean there's 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 lifecycle of the protocol execution. The module also comes embedded with an advanced statistics engine for predicting shelf life for long-term storage conditions.

Bio4C ProcessPad™ automates many steps involved in CPV. ICH Q10 Guidance and the FDA's Process Validation Guidance both emphasize routine process monitoring and CPV as an integral part of process validation and its lifecycle management. Bio4C ProcessPad™ automates many CPV tasks and provides:

• Data integration and warehousing of all relevant historical process information
• Lot traceability and genealogy
• Correlations across process steps for quick troubleshooting
• Overlaying batch trends
• Templating specific process parameters for routine periodic trending
• Historical limits management
• Validated reporting

For additional detail on Bio4C ProcessPad's™ CPV support, read the eBook Continued Process Verification Using a Software Platform or watch the webinar How to Develop a Regulatory-compliant Continued Process Verification (CPV) and Process Monitoring of Bioprocesses.