Automation initiatives in production over the last decade where driven by the need to precisely control production processes and cut costs. That environment is now being further adjusted by reviewing the costs associated with non-value added tasks. An identified area is the huge amount of paper processes used in manufacturing, particularly quality control and quality assurance functions. This “e-manufacturing” initiatives have received attention as one of a small number of critical-path issues that, if solved, will yield significant cost savings for decades. Going paperless in manufacturing’s laboratory functions will allow the QA/QC operations to manage the master data across the enterprise’s facility and geographical boundaries. Some key insights obtained from a research survey conducted by VelQuest Corporation in 2002 entitled “Laboratory IT – Enabled Solutions Research Report”, are revealing:
“Our company has a priority initiative to delegate decision-making, enrich jobs and create accountability for delegated decisions. We see paperless labs as a tool to empower analyst to fulfill this charter. We also want to reduce the time lab supervision spends on review and investigations, so they can work on process improvement.”
“We believe [that through paperless labs] real-time feedback enables analysts to reduce errors, minimize rework loops and correct ambiguous results immediately.”
The key issues mentioned here are reduced review times, reduced operator errors, minimizing rework and investigations and ultimately enhancing the work experience for well trained analysts and operators. All of these issues contribute to costs and product release cycle times, and if eliminated or minimized, will significantly affect an operations bottom line.
SmartLab GMP Electronic Notebook System
In 1999, VelQuest Corporation (www.velquest.com) developed a unique, and now patented, process to embed an automated data capture software application within a company’s existing SOP’s or methods. In doing this, the software presents only the approved method to the analyst/operator and captures all the critical data created during the process of implementing a method on the lab or process floor. Data elements include method preparation data (reagent info, weighing operations, etc.), analytical instrument data (chromatography and spectroscopy), and analyst or operator observations (color, texture etc.).
The COTS (commercial off-the-shelf) software takes your existing written protocols (methods or SOP’s) and presents it as an electronic version with embedded data capture technology. Analysts and operators interact with the digitized SOP through PC’s or hand-held tablets that force data entry/capture either manually or automatically (direct from instruments). At the end of the process ALL the data is aggregated in a reviewer screen with all data flagged for specifications and a direct link to the original data source. Raw data files are automatically captured and organized in a secure repository for future needs. Access to the system is controlled via a secure and granular privilege grid with full audit trails and electronic signature capabilities providing full compliance with the FDA’s 21CFR Part 11 regulations. The result data is fully accessible to any authorized member of the management team. Customized reports including certificates of analysis for batch release documents can then be automatically created and approved. Data and trending reports can also be easily exported to other in-house IT infrastructure requirements such as a CDS, LIMS or ERP/MRP systems. In many respects, this technology represents the “process analytical technology” (PAT) applied to the laboratory processes. Just like physical manufacturing processes, the lab environment utilizes “method processes” conducted by analysts and through embedded “method-centric” software, the PAT philosophy can be applied to the lab with equivalent productivity improvements and significant returns on investment.