The #1 Gap in Manufacturing Software Today

It’s 2018 and technology has pervaded every area of our lives. Yet a visit to almost any manufacturing floor reveals that paper is alive and well, even in forward-thinking companies with strong IT strategies and digital transformation initiatives in place. It seems manufacturers just can’t shake it. But with a multitude of commercial manufacturing software solutions on the market, why is it that the truly paperless factory floor remains so elusive?

A new white paper examines the current manufacturing software landscape, explains how to select the right solution, and identifies the main gap in functionality that has prevented companies from going fully paperless.

Trending Toward Paperless Manufacturing

The benefits of a paperless factory floor are many and well-documented, such as eliminating human-introduced error, significant savings in cost and time, a more reliable audit trail and increased compliance, among others.

The latest, and perhaps most compelling, advantage of digitalizing and automating production workflows and documentation is that it allows companies to tap into the data-driven intelligence of Industry 4.0 and smart manufacturing. Associated with the cloud, big data, artificial intelligence (AI), the Industrial Internet of Things (IIoT) and predictive analytics, this new wave of connected digital technologies provides access to unprecedented insights and efficiencies, and represents significant competitive opportunities that can only be fully leveraged in a paperless environment.

But this is not to say that going paperless is a new concept. For regulated companies, the shift to paperless began in earnest in 1997 when the U.S. Food and Drug Administration (FDA) released 21 CFR Part 11, its final rule on electronic records, electronic signatures and audit trails. The FDA remains a proponent of paperless and continues to develop rules and guidelines in this direction.

The #1 Gap: Digital Production Records

Across the industry, companies continue to recognize the criticality of going truly paperless to their future success and viability in a quickly evolving manufacturing space. And despite heavy investments in manufacturing software and automation technologies, it is clear that challenges persist.

Discussed in much greater detail in the white paper, the leading manufacturing software solutions in use today include:

• Material Requirements Planning (MRP)/Manufacturing Resource Planning (MRP II)
• Manufacturing Execution Systems (MES)
• Shop Floor Control
• Recipe Management
• Enterprise Resource Planning (ERP)
• Supervisory Control and Data Acquisition (SCADA)

In an attempt to address the documentation burden, software vendors often promise their solutions can eliminate paper from the factory floor altogether, but most are only able to reduce it. Furthermore, existing solutions fail to automatically compile and generate the full range of production record types used by companies across all verticals, including batch records, device history records (DHR), production travelers, history records, batch production records (BPR), manufacturing history records, recipe management records, genealogy records, master production records and many more.

This lack of automated documentation and digital production record functionality represents the biggest functional gap in commercial manufacturing software today, and is largely responsible for the industry’s continued dependence on paper.

To bridge this gap, manufacturers need a solution that can serve as a digital thread – connecting and integrating all enterprise solutions and providing a system of record for the volumes of data they produce.

Companies must seek and adopt a new kind of manufacturing technology that elevates their existing IT solutions by enabling the transfer of information between systems and departments, removing the barriers to generating consistent and compliant production records and documentation, and minimizing the interface between humans, machines and paper.

Such a digital production records solution should provide the following functionality:

• Digital Production Records: Automatically collect required production details, compiled in a compliant and consistent format according to CGMP and other requirements, and supporting all types of production records.
• Data Integrity and Transparency: Perform real-time data checks to ensure it is complete and in the correct format, eliminating the risk of incomplete data, illegible text, incorrect date formats, incorrect units of measure and other common documentation issues.
• Automation of Routine Tasks: Reduce the human points of contact with machinery and documentation to avoid human-introduced error. The system should automatically track and enforce employee training, consistent and proper use of SOPs, and monitor individual and team performance.

The industry’s struggle to go fully paperless is neither for lack of desire among manufacturers nor lack of available manufacturing software options. Rather, it’s for lack of a solution that can truly eliminate paper from the factory floor. In this age of data-driven intelligence, smart manufacturing and constant technological innovation, it’s more important than ever to bring manufacturing to a truly paperless state. Therefore, going paperless is a manufacturing imperative.