QUALITY ASSURANCE/CONTROL functions are designed to provide optimum productivity while maintaining the highest quality control standards. These functions are powerful, yet easy to use, and provide for a method of cost control and man-hour efficiencies.
Results Verification is a “must” for organizations needing to reduce the work involved in audit preparation. This tool provides the ability to review critical analysis automatically and includes many features that reduce the time consuming process of verifying analytical results. The reviewer has the ability to graphically review (through SQC) historical trends during the verification process. The verification privilege is assigned at the user level, and identification and time stamps are applied throughout the verification process. Rejected results are reassigned to the appropriate backlog.
SQC Charting provides quick access to graphical trend data for all points in the LIMS without an extensive setup or macros. SQC utilizes Shewhart control charts (X-bar and Range with selectable sigma, Histograms, etc.), provide quick access to data, and are viewable from verification, data entry or data search screens. These features facilitate many business process that lead to improved analytical quality. It allows an organization to easily determine which analytical results are “out-of-control” according to Western Electric Run Rules. This applies at the sample point level, and reports each violation and which of seven rules was violated. This feature simplifies QA/QC’s job in identifying areas where laboratory analytical methods or manufacturing processes need attention.
Technician Certification enhances security and regulatory control by providing an automated method of tracking training needs and changes in technician certification status. This function monitors training needs of technicians, provides early warning of technician training requirements, performs automatic notification of technician change status, and prohibits non-certified technicians from entering results.
Standard Operating Procedures (SOP) improves efficiency and control by providing easy access to online procedures and analytical methods. Features include instant access to analytical test SOP’s and revision tracking. Documents may also be generated using any OLE compatible programs, such as Microsoft Word, Word Perfect, Paint, Movie, Audio Clips, etc.
Accounting provides analytical testing cost data sorted by unit, laboratory, analyst, and time for scheduled and unscheduled samples. Reports may viewed on screen or exported to a number of different file formats. The user may also define multiple rate chart schedules, so that tests may be charged at different rates based on assigned sample priority.
SQC Limit is valuable tool for organizations that want to easily incorporate an advanced SPC program into their laboratory business processes. It allows the Systems, Laboratory, or Operations Manager to easily focus on areas of most importance and applies selected Shewhart rules to change one level of specification limits for a test profile. An excellent tool for audit preparation, SQC Limit provides an early warning of analytical test quality problems and makes determinations immediately available at results entry. |
