As the landscape of pharmaceutical manufacturing has changed in the last few years, one exciting shift has a distinct possibility of being a game changer in coming decades. Regulatory agencies have increasingly begun to recognize the importance of automation technologies, and, as a result, have incorporated more automation into their guidelines for good manufacturing practices (GMP). This trend aligns with industry’s shift toward more automation to reduce errors, eliminate waste, reduce patient risk, and improve and sustain availability and quality.
In her recent article in Pharma Manufacturing, Emerson’s Michalle Adkins explores how choosing the right automation solutions—particularly a distributed control system (DCS) and manufacturing execution system (MES) that are inherently designed to support ALCOA+ guidelines—can help organizations maintain data integrity in their operations. That move toward increased data integrity will help them deliver the desired benefits (safe, high quality, and efficient production) from their automation investments.
Data integrity is crucial
Without automation, Michalle explains, many organizations follow poor records and documentation management practices. Ultimately, these issues can create significant problems during a regulatory audit. If sign-offs and verifications cannot be adequately proven, companies can face steep fines and significant risk to their reputation.
Automation between inherently integrated systems like the DeltaV DCS and MES help teams circumvent these problems. As Michalle explains,
“One key benefit of leading DCSs is the functionality to ensure data collected during manufacturing is generated while inherently incorporating the elements of data integrity. There are also several benefits provided by the MES, since it can be used to ensure data capture, data flow, and signatures are enforced. As a result, issues due to poor data collection are automatically avoided.”
Advanced systems, like Emerson’s DeltaV DCS and MES are also built to support compliance with key regulations like 21CFR Part 11, as well as providing key features such as revision tracking, change management, and security controls to protect the software and maintain its validated state.
It takes more than tech
Michalle is quick to remind readers, however, that technology is not the only key element to maintaining data integrity. It must be aligned with work processes and a corporate culture that promote the value of supporting GMP through ALCOA+ guidelines. Michalle shares,
“Data integrity requires more than just enabling technology; organizational culture and people must also be considered in the overall governance and management processes. Finally, standardized work processes need to be documented and followed to ensure data integrity.”
Michalle digs deeper into meeting ALCOA+ standards in her full article over at Pharma Manufacturing. She not only breaks down each element with suggestions for how to meet them, but also shares real-world examples from organizations in the life sciences industries. Head over there to get all the details!
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