The pharmaceutical manufacturing industry stands at the cusp of a digital revolution. With the advent of groundbreaking therapies and the shift between outsourcing and insourcing manufacturing, the need for a robust, adaptable data platform has never been more critical. Enter Connect CPV™ — the platform designed to navigate the complex landscape of Pharma manufacturing by tackling its main challenges head-on.
Adapting to the Ever-changing Business Model
The Pharma industry’s dynamic nature demands flexibility in how manufacturing data is managed, whether it’s sourced in-house or from a Contract Manufacturing Organization (CMO). Connect CPV™’s Genealogy module offers unparalleled adaptability, ensuring seamless access to data across diverse manufacturing models. This flexibility is crucial as the industry evolves, embracing innovative treatments like mRNA, cell and gene therapies, and CRISPR-based therapies.
Tackling System Complexity
Pharma manufacturing generates vast amounts of data across the ISA 95 system layers, from IoT and PAT data to ERP systems. This diversity presents a significant integration challenge. Connect CPV™ rises to the occasion with easy connectors for any system, ensuring that data integration and architecture can handle variations in system sets, simplifying what has traditionally been a complex undertaking.
Ensuring Data Integration & Quality
Integrating and standardizing data is a monumental task that requires a sophisticated approach. Connect CPV™ leverages native AI algorithms to contextualize data at the unit operation and batch level efficiently. The platform’s “Views” module further standardizes and governs data from different sources, setting a new standard for data quality in Pharma manufacturing.
Upholding Compliance and Security
In an industry where compliance and security are non-negotiable, Connect CPV™ ensures peace of mind. The platform’s commitment to CFR Part 11 compliance and its robust security measures across application, storage, and computation layers mean that manufacturers can focus on innovation without compromising on compliance.
Facilitating Change Management
The introduction of new technologies often meets resistance due to longstanding practices. Connect CPV™ addresses this through comprehensive online training, communication, and workshops, ensuring smooth transition and user adoption. This focus on change management is vital for harnessing the full potential of digital platforms.
Scalability and Future-Proofing
Unlike traditional systems that rely on rigid data models, Connect CPV™’s flexibility allows it to adapt to any manufacturing process without software redesigns. This scalability and future-proofing are critical as Pharma manufacturing continues to evolve, ensuring that the platform remains relevant and effective.
Integrating with Existing Processes
Integration with existing business processes is seamless with Connect CPV™’s Data As a Service (DAAS). This flexibility allows for easy access to valuable, contextualized manufacturing data, driving multiple business outcomes and fostering innovation.
Enhanced Comparative Analysis: Continuous Process Verification (CPV) Solutions in the Pharmaceutical Industry
The landscape of Continuous Process Verification (CPV) solutions within the pharmaceutical sector is diverse, with various tools and vendors offering specialized solutions and services to meet the industry’s complex demands. While some solutions are purpose-built for CPV, others leverage custom approaches designed by teams of experts. Here, we highlight three notable vendors known for their dedicated CPV solutions and introduce Mareana’s unique approach with Connect CPV™.
Biovia Discoverant:
Biovia Discoverant stands out for its robust data contextualization capabilities, allowing for molecule-specific configuration. It offers flexibility in adapting to numerous backend data sources and provides custom charting features for generating process control charts. Its strength lies in parameter-level contextualization, catering to the nuanced needs of pharmaceutical manufacturing.
Skyland PIMS:
Skyland’s PIMS (Process Information Management System) distinguishes itself as a 21 CFR Part-11 compliant, cloud-native solution. It excels in creating a contextualized data backbone, essential for managing critical manufacturing processes and quality data across products and batches. Designed to facilitate CPV and Annual Product Quality Review (APQR) reports, PIMS is built for seamless CPV support.
PharmaMV:
PharmaMV delivers a comprehensive suite of CPV tools designed to enhance integration with process and production environments. Its capabilities include reporting real-time results and soft-sensor data for Critical Quality Attributes (CQA) predictions, ensuring processes remain under control during routine production, and adhering to FDA process validation requirements.
Mareana’s Connect CPV™: A Visionary Approach:
While many CPV solutions focus narrowly on application-based needs, Mareana has pioneered a broader strategy. Recognizing CPV as a critical entry point, we’ve developed Connect CPV™ as a validated data platform tailored for the evolving demands of pharmaceutical manufacturing. Beyond addressing CPV necessities, Connect CPV™ is foundational, embedding the core capabilities required of a data platform to adapt and evolve with the industry’s shifting landscape.
Connect CPV™ transcends traditional boundaries by addressing the industry’s fundamental challenges, laying the groundwork for a future driven by data-centric manufacturing excellence. In embracing digital transformation, Connect CPV™ emerges not merely as a tool but as a strategic partner committed to sculpting the future of pharmaceutical manufacturing.
