In all analytical laboratories, the purchase, preparation, storage, and control of chemical reagents, standards, and working reagents are routine tasks. In a compliant environment (such as the life science industry), the documentation of important metadata concerning the solutions and materials is critical for proper control of the preparation process and assurance of proper procedural completeness, accuracy, and documentation. Key information such as manufacturer, purchase date, quantity, expiration date, usage by analyst, and minimum inventory needs is required to effectively manage the operations and provide the context link of these consumables to the analytical data. Today, the traditional process is paper-based using notebooks and forms that often require reviews and approvals by peers or supervisors. In a paper-based environment, the chemical reagents and materials management is subject to resource training and compliance with standard operating procedures that are often difficult to monitor and control.
Figure 1 - SmartLab CIMSplus Freedom workstation.
The SmartLab CIMSplus Freedom™ workstation (VelQuest Corp., Hopkinton, MA) (Figure 1) automates the checking in and out of critical chemicals, standards, and working test method reagents utilizing electronic-based capture of all relevant usage with full audit trails and management reporting. In addition to a comprehensive “track and tracing” capability, the workstation provides a set of work instructions for authorized analysts to prepare solutions via a PC workstation located in close proximity to the laboratory storage area. It offers a fully electronic means of executing the instructions and capturing and cataloging all of the data and metadata as the material is added to the inventory and used by operations— in real time. In addition, the system connects to existing balances and pH meters to capture the data directly to the database in compliance with laboratory documentation best practices. Since all of the data and metadata are captured in a database, reports are easily prepared for supervisory review and management insights such as consumables pedigree, inventory turns, laboratory investigations, usage logs, and a host of other information.
Typical materials that need to be managed include standards and controls, matrix standards, buffers, HPLC mobile phases, HPLC columns, dissolution bath media, environmental monitoring media, controlled substances (National Institute on Drug Abuse [NIDA] laboratories), radiolabeled materials, internal standard reagents, and so on—any user-defined consumable can be added to the system.
Figure 2 - Analyst or manager dashboard view of real-time laboratory inventory status. Each item/graphic view is user configurable based on individual requirements. The number of units in stock, location, reagents needing preparation, usage by analyst, etc., can all be displayed for a quick view of information.
Figure 3 - Addition of a new solution to the SmartLab CIMSplus Freedom workstation is done by answering a few questions with individualized work flows for each type of consumable.
Figure 4 - Each consumable item has its own work flow scheme (via “drag and drop” icon editor) for each state the material is in.This enables individualized life cycle work flows for all inventory management items.
Figure 5 - Work instructions are presented to analysts to walk them through the preparation with automated data capture from balances and pH meters. Actual real-time instrument data automatically populate appropriate fields in the SmartLab CIMSplus Freedom workstation database (in this case the mobile phase expiration date) along with all metadata on this preparation.
Workstation operation
The SmartLab CIMSplus Freedom workstation is powered by the VelQuest SmartLab GMP Lab Execution System/ELN, the first method-centric automated compliance system that automates standard test methods (STMs) or standard operating procedures (SOPs) with data captured directly from analytical instruments and within the context of the procedure. This configurable platform is now defined for specific laboratory applications in which repetitive work flow tasks often require compliant and comprehensive documentation and cataloging, such as laboratory-based chemical/consumables inventories and reagent management.
The workstation comprises a touchscreen PC that can stand on its own or be networked within the company's operations. Analysts and operators interact with the system, which monitors user authentication and manages the preparation, addition, and real-time disposition of the contents of the inventory. As analysts check in and check out chemicals, reagents, mobile phases, HPLC columns, microlaboratory media, etc., the workstation captures the content changes over time. At the end of the process, all of the data are aggregated in a user-defined report dashboard. Access to the workstation is controlled via a secure and granular privilege grid with full audit trails and electronic signature capabilities. This key feature eliminates the need for paper-based log books stationed throughout the laboratory, each of which requires management control and reporting. This is now done electronically in real time.
Each inventory item has its own work flow for creation, use, and disposition. The work flow is created using a "drag and drop" icon process; thus the setup requires no programming-based coding. Any laboratory analyst or technician with access rights can manage and use the system. Customized dashboard and written/printed reports can be quickly created and approved.
Label and bar-code compatibility
The SmartLab CIMSplus Freedom workstation allows information to be communicated via a bar-code labeler and reader for proper tagging of the containers (or items) for use by analysts during their routine testing processes. Through the bar-coding reading, the entire pedigree of the consumable is known and documented, all within the touch of a button. Figures 2−5 outline HPLC mobile phase preparation, addition to inventory, and use to illustrate the capabilities of the system.
Benefits of electronic control of laboratory consumables inventory management
Figure 6 - The bar code associated with this mobile phase preparation is printed out for disposition on the container. All relevant pedigree metadata from the SmartLab CIMSplus Freedom workstation database are captured and are available during usage of this reagent in the laboratory.
The path to the paperless laboratory traditionally involved the custom-coding of IT systems to provide a listing of materials; however, modern laboratories require comprehensive control and electronic capture of all metadata associated with the addition, preparation, use, and disposal of consumables. By creating a fully preconfigured workstation, the system is up and running in a day; in validated environments (pharmaceutical laboratories) the system is operational and validated in 2−3 days. Key benefits include:
- Improved productivity of documentation and review processes for the creation, use, inventory, and storage of all laboratory consumables
- Comprehensive pedigree of laboratory consumables (who, what, when, and where) for compliant control and documentation
- Work flow instructions and ELN capture of information with direct instrument connectivity to a balance and pH meter for the creation of new solutions, reagents, mobile phases, etc.
- Elimination of paper-based logbooks and their management in both regulated and nonregulated laboratory operations
- Bar-code printing and scanning for ease of information management for the creation, use, and disposition of all laboratory materials (see Figure 6)
- Elimination of paper-based transcription and calculation errors during preparation of solutions
- Because the SmartLab CIMSplus Freedom workstation is powered by the SmartLab Lab Execution System/ELN, the system is extensible to a full enterprise method execution system at any time
- User access control and viewable audit history provide technical controls for any regulatory compliance requirements for user-definable consumables.
Installation and training for the SmartLab CIMSplus Freedom workstation are completed in one day. The workstation is provided with the following components:
- LCD monitor with touch-screen user interface and keyboard
- Bar-code label printer and reader
- Integration with existing balance and pH meter for full electronic data capture during preparation and use
- Step-by-step procedure work flow ELN for compliant documentation of materials preparation
- Connection to network or completely independent with laboratory-based server.
For less than the cost of an HPLC system, laboratories can free up valuable management resources; eliminate paper logbooks and their management tasks; and compliantly prepare, track, and trace laboratory consumables.
Mr. Helfrich is VP, GMP Automation Programs, VelQuestCorp., 25 South St., Hopkinton, MA 01748, U.S.A.; tel.: 508-497-0128; fax: 508- 497-2396; e-mail: [email protected].