GxP Lifeline
5 Key Areas for Life Sciences Manufacturers to Prioritize in Manufacturing Software
Digital transformation efforts have picked up in various areas of manufacturing in the past few years. Approximately 67% of manufacturers have accelerated digital projects as a result of COVID-19, with manufacturing decision makers citing improving operational efficiency as the most significant business imperative, according to a recent assessment of digital transformation in manufacturing.1
Though most manufacturers may recognize the benefits of digital transformation, many still face real barriers to adopting new technologies, including securing funding, reworking processes, retraining personnel, and rolling out implementation. Before all of that is the challenge of determining which digital tools to invest in.
According to the digital transformation assessment, which was published by The Manufacturer and IBM, manufacturing decision makers say that selecting the technology to adopt is among the most significant barriers to adopting new technologies.
Selecting the Right Manufacturing Software to Adopt
With the right modern manufacturing execution software, time spent in the past on manual systems and processes can instead be spent optimizing manufacturing processes and accelerating product release. However, even as new technologies provide life sciences manufacturers with smarter, faster, and more cost-effective ways of improving production, choosing the right manufacturing software to transform production processes can be challenging. Considerations include the costs and complexity involved in a large-scale IT effort, plus the time it takes to implement and validate a new system.
By determining the capabilities that fundamentally complement an organization’s quality manufacturing goals and current practices, manufacturers will be better prepared to choose the modern manufacturing execution software tools they need to succeed.
Modern Manufacturing Execution Software Checklist
Below are some core areas where modern manufacturing execution software can, and should, provide the essential functionality needed to address pharmaceutical and medical device manufacturers’ pressing production needs.
- Production records – Whether working with batch records or device history records, manufacturers that completely digitize their records can ensure complete data capture, enhanced data integrity, real-time deviation tracking, up-to-date operator training, robust collaboration, work-in-progress visibility and traceability, and robust analytics and reporting.
- Equipment calibration and maintenance – Manufacturing software can automatically route and track calibration and maintenance data, simplify management of the calibration and maintenance schedules, generate calibration and preventive maintenance tasks before they’re due, maintain complete records securely, and provide advanced reporting capabilities.
- Product variations – Manufacturing software can simplify the creation and management of product recipes and variants, easily manage substitutions and related change control, consolidate recipe and variant data, ensure consistency across all products, and allow the manufacturer to quickly scale up and out as needed.
- Analytics and reporting – Manufacturing software can empower operations and quality departments with instant, in-process data access and analysis and cross-platform, user-determined data insights. Prebuilt interactive dashboard libraries and user-friendly data exploration and visualization should provide pick-up-and-use simplicity. Robust data sharing and scheduled reporting should help resolve data integrity issues before they spread.
- Software Validation – Manufacturing software should include a risk-based validation approach that focuses on critical business processes, leverage the software provider’s internal validation testing as well as advanced technology that accelerates overall validation time, allow for simpler upgrades and sustainable validation in the cloud, and implement a methodology based on U.S. Food and Drug Administration (FDA) guidelines and proven best practices.
Close the Offline Data Gap with a Modern Manufacturing Execution Software
As reflected in each area, data integrity, visibility, and management are crucial in how life sciences manufacturers reshape their operations with digital tools. By closing the persistent offline data gap caused by paper and disconnected systems, modern manufacturing software enables manufacturers to unlock real-time insights and unleash powerful intelligence.
Modern manufacturing software like MasterControl’s Manufacturing Excellence solution enables manufacturers to streamline production, quality review, and product release and finally achieve complete, end-to-end smart manufacturing.
Resource:
- ""2021 Digital Transformation Assessment,"" The Manufacturer/IBM, February 2021.
David Butcher has covered business and technology trends in life sciences and industrial manufacturing for more than 15 years. Currently a content marketing specialist at MasterControl, he previously served as editor of Thomas Publishing’s Industry Market Trends and as assistant editor for Technology Marketing Corp.’s Customer Interaction Solutions. He holds a bachelor’s degree in journalism from the State University of New York, Purchase.
