The manufacturing of personalized medicines is more complicated than one-dose-fits-all. For pharmaceutical manufacturers to get the benefits of precision medicine, they need to establish data consistency across all their plants and business units to flexibly adapt to any changes as they happen for faster and more seamless manufacturing, quality control, and product approvals.
Knowing When Data Lacks Consistency
Global pharmaceutical companies have a widely distributed manufacturing base — with facilities spread domestically and internationally across contract manufacturing partners and new entities emerging through mergers and acquisitions. This creates a challenge in preserving comprehensive data visibility across all processes and implementing consistent and continuous quality control.
Using conventional data governance and management practices makes your data more of a hurdle than an asset. It entails spending more time, energy, and resources on data wrangling tasks. Compliance, quality control, and process improvement will remain a source of frustration.
The following questions can help you diagnose the health of your data management. If you answer yes to any of these questions, your pharmaceutical company will need more optimal data governance and management strategy.
- Are our processes not standardized across all sites?
- Do we lack a one-stop, single source of truth for all data and analytics needs?
- Do we still:
- Manually collect, digitize, integrate, exchange, and analyze data?
- Manually monitor critical parameters and process variations?
- Manually trace data and changes in processes?
- Manually create and publish analytics, quality, and compliance reports?
Making Data Consistent
Data consistency and data integrity go hand in hand. In the pharmaceutical industry, any error could mean serious consequences. This is why it’s essential to maintain and ensure data consistency and accuracy across plants and business units all throughout the data lifecycle. And keeping data consistent means it is unchanged from the very start to the very end.
Keeping data consistent, accurate, and secure has been standardized so they can be regulated and yield better outcomes; hence, the ALCOA principle. ALCOA stands for:
- Attributable. All captured information should identify the data source and accurately document any changes made.
- Legible. Data must be recorded and stored in a secure method that will ensure readability for the full period it will be used.
- Contemporaneous. The data must be recorded when it is generated or when an event is observed.
- Original. The data must be presented as it was created.
- Accurate. Data must be verified that it is error-free. Data accuracy must be demonstrated as correct through repeatable calculation, algorithm, or analysis.
Data consistency is critical in the pharmaceutical industry to ensure the end products meet all quality standards and requirements. Any deviation in data integrity shall result in regulatory actions.
Enabling Data Consistency with Next-Gen CPV
When implementing change, you need to look at the entire process holistically while obtaining granular visibility into all units to ensure innovations will result in positive outcomes. It is essential to identify and remove bottlenecks that hinder you from accelerating compliance, traceability, and innovation. You need to remove the data hurdles that prevent standardizing and simplifying quality control and change implementation.
Mareana’s Next-Generation Continued Process Verification (NextGen CPV) empowers you to achieve these goals. It allows you to:
- Optimize your data governance and management practices.
- Enable standardized and automated processes across the enterprise.
- Accelerate compliance, innovation, and return-on-investment.
Mareana’s NextGen CPV is purpose-built software for FDA Process Validation and Compliance. It leverages Mareana’s Manufacturing Intelligence and Modeling Platform to enable pharmaceutical manufacturers to standardize processes, automate manual procedures, and reduce manufacturing variability. Mareana’s AI models increase process understanding, control, and product performance.
NextGen CPV radically improves process monitoring by allowing you to:
- Monitor ongoing manufacturing in a consistent manner.
- Enable standard and consistent processes across all sites.
- Monitor and change parameters in real-time for optimal yield.
- Implement a consistent way of organizing data across all data silos.
- Extract data from paper batch records for analysis.
NextGen CPV enables end-to-end data connectivity, kickstarting your digital transformation to a smart factory so you can realize dramatic business objectives.
- Improve predictability
- Increase efficiency
- Ensure compliance
- Reduce costs
Contact a Mareana data expert to help you create sustainable outcomes now.