Giuseppe Menin, life sciences and process industry manager at COPA-DATA, highlights how an automation integration layer can streamline data management, ensuring compliance with the ALCOA principles—Attributable, Legible, Contemporaneous, Original, and Accurate.
Pharmaceutical companies are under increasing pressure to meet the rising demand for diverse medications. According to IQVIA, global medicine usage is projected to grow by 12% by 2028, driven largely by innovative therapeutics and the availability of more affordable generics and biosimilars. This surge necessitates handling larger volumes of data, underscoring the importance of robust data management systems.
The ALCOA principle and its expansion
ALCOA, recently expanded to ALCOA+ to include Complete, Consistent, Enduring, and Available, forms the foundation of data integrity standards set by regulatory bodies like the FDA and EMA. Non-compliance can lead to severe repercussions, including warning letters, non-compliance reports, fines, and even criminal prosecution.
Despite the awareness of data integrity’s importance, pharmaceutical manufacturers often struggle with accurate and consistent data collection, analysis, and storage. Traditional paper-based processes pose significant risks, including human errors and the potential for tampering.
Challenges in data integrity
Legacy equipment and the lack of standardized protocols further complicate data integrity efforts. Even with a Manufacturing Execution System (MES), manual data transcriptions, known as "paper-on-glass" practices, remain error-prone. Additionally, older machinery from various vendors often lacks the ability to communicate seamlessly, adding another layer of complexity.
The role of automation integration
Automating the integration of data across all production stages is crucial for overcoming these challenges. COPA-DATA’s zenon Automation Integration Layer (AIL) software exemplifies this approach, providing connectivity to machines from multiple vendors, including older equipment.
Zenon ensures that data is automatically contextualized and archived, minimizing the risk of data loss or inconsistency. This automation detects incomplete or incorrect entries, enabling real-time data access and immediate issue resolution. Operators can rectify faults during production, significantly reducing time to market and associated costs.
Ensuring accurate recipe management
In pharmaceutical manufacturing, precise recipe management is critical. Zenon allows operators to select pre-set recipes, eliminating human errors during production setup. The software guides users through each step, ensuring data completeness and adherence to specified tolerances.
Towards automated data integrity
As pharmaceutical companies expand their product lines, maintaining compliance is essential. Efficient data management through automation not only ensures compliance with data integrity standards but also reduces costs and accelerates time to market.
Menin emphasizes that automation integration is key to meeting ALCOA+ requirements.
"Automated systems like zenon not only enhance data accuracy but also provide real-time access, ensuring compliance and efficiency in pharmaceutical production," he notes.
Tofidence, a biosimilar to Actemra, is approved for treating moderately to severely active rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, and systemic juvenile idiopathic arthritis. This FDA-approved biosimilar offers an affordable alternative, helping to alleviate the financial burden on patients and the healthcare system.
Automating data integrity processes is not just about compliance; it’s about improving overall operational efficiency and ensuring that patients receive safe, effective, and high-quality medications.
