Features
Details Matter - Fill the Gaps In Your Quality Management Program
Quality Management for all Laboratory and QA/QC Deviation tracking, OOS, CAPA investigations, data analysis and quality improvement programs
Quality Management and Deviation Tracking is often a hit or miss proposition in laboratory organizations and often has many paper-based or home grown systems. These systems make inefficient use of analysts and manager’s time as well as opening the door to regulatory and audit observations. SQL*LIMS QEMS provides the analyst and manager a web based solution to initiate, manage and analyze quality events including goal based quality improvement initiatives. As part of a workflow, iSQL*LIMS QEMS is an out of the box solution.
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- Cost Reduction – Less personnel time is used tracking compliance tasks manually, paperwork, and clerical functions
- Productivity Improvements – Spend less time searching for, moving and tracking paper documentation for review and long-term retention. Solution provides on-Line tracking of all events, whether deviations, risk assessments, regulatory commitments, audit observations.
- Enhanced Reporting and analysis – Capability to measure Quality Program Effectiveness, analyst workload and compliance. Dashboard data mining and data analysis to assure effective use of resources and management of risk. Localized data roll up for ability to assess the Quality System and Annual Reports
- Ease of Use – Graphical driven reporting and use of user dashboards. No Learning Curve. Effective Dashboard Management for Lab Analysts, Managers and Executives.
- Ease of Administration – Centralized deviation/CAPA tracking.
- Ease of Integration - Feeder for corporate CAPA Systems. Certified SAP™ connector for batch exception reporting. Ability to integrate Stability studies cases. Ability to include Microbiological environmental monitoring cases.
- Workflow Support - Escalation of cases to corporate systems that track cross-area quality events. Subscription capability to Email to assure timely communications for assignees and conformance to due dates.
- Ease of Support – Single, first line support for SQL*LIMS QEMS
- Enhanced compliance – Instant information to avoid 483’s. Capability to assist in Quality Program Evaluations. Supports searchable electronic records for quality events. Supports GMPs/GLPs , ISO 9001, ICH Q10 and ISO 13485 processes.
Seeing is believing - Integrated intuitive dashboards
Better decisions, faster responses, higher efficiency. An intuitive dashboard is allowing the analyst or manager to see and act on their work instantly without training. The SQL*LIMS® QEMS user dashboard provides an intuitive interface with a ‘work list’ capability, allowing the user to see and act on their work, and the work of others. The user can filter the contents of the dashboard by assigned person, by task type, by status, by log date, by due date, or by tracked item. When filtering by tracked item, all the events relevant to the specified lot are listed at once and can be individually viewed, resulting in greater understanding of the entire lot.
The executive dashboard allows the manager to review the organizational performance and status of exceptions.
Workload for users or teams is easily discerned. As an example, the above graphs show the open cases by severity for the QA/QC team for deviations only and the work distribution.
Details Matter
The design supports tracking the complexity of quality across multiple manufactured lots. Integration is bi-directional allowing integration with corporate CAPA, ERP and MES systems. SQL*LIMS QEMS provides a simplified singcollection point le data for managing quality for a single laboratory or multiple laboratories including multiple plant sites. Ease of administration is supported by connection to multiple databases and as an integration point for non-laboratory data sources. Laboratory quality events are created, tracked and closed with full traceability for regulatory compliance.
Better decisions can be made for lot release with all quality data known and minimization of risks to avoid 483's.
SQL*LIMS QEMS provides the user with an easy to use web based application to initiate, manage and analyze quality events including goal based quality improvement initiatives. The laboratory manager can easily see that samples, tasks, lots and stability studies in LIMS have Cases (exceptions or quality assignments) that need to be evaluated as part of the laboratory approval and acceptance processes.
For more information Contact us to demonstrate in detail how Quality Management for Deviation tracking, OOS, CAPA investigations, analysis and quality improvement programs can be deployed in your organization.
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