Using LIMS for Quality Control Process

1. ~ By Sanjana USING LIMS FOR QUALITY CONTROL PROCESS

2. INTRODUCTION EDIT IN POWERPOINT® Click on the button under the presentation preview that says "Download as PowerPoint template". You will get a .pptx file that you can edit in PowerPoint. Remember to download and install the fonts used in this presentation (you’ll find the links to the font files needed in the Presentation design slide) Keeping up with the fast-evolving world of trends means that smart work with innovation is required. Having a smart-infrastructure built on informatics solutions can benefit the lab by implementing automation. Laboratory Information Management System (LIMS) is a critical part of the system to be incorporated in all functioning laboratories for better results. The LIMS of today has gone far beyond just sample management invoking functions like resource management, workflow management and many more. By adhering to National Accreditation Board for Testing & Calibration Laboratories (NABL) standards, labs can manage NABL quality indicators easily. 2

3. Quality control in LIMS Quality control in LIMS is the process of assurance of quality at every stage included in the automation system. It may also be called as a statistical process used to evaluate the analytics produced in the patient’s results. The sampling of the product is continued after every successful stage until the end of the sample management process. Quality control is very essential in a LIMS used in clinical laboratories as the result cannot be tampered with. Quality control is done on three major factors in a clinical lab, which are: Quality control on the sample Quality control on the utilized equipment Quality control for the process. ● ● ● For quality control of the sample, the result might either be quantitative or qualitative. Meaning that the result can either be a number count (hemoglobin count in blood) or can define if the test result is positive or negative or can be limited to a few different values alone. Quality control checks on the equipment or instrument are used to validate whether the instrument is operating within pre-defined specifications, inferring that patient test results are reliable. Once this validation is completed, the result of the patient can be used for further diagnosis. 3

4. SAMPLE MANAGEMENT Sample management is the primary process of a LIMS system. Any QC lab needs to analyze many kinds of the sample depending on the industry of the laboratory. Our QC laboratory helps in the analyses of samples in a unique and distinct method. We have the following salient features for sample management: ● Single sample management and multi-sample management by using templated management techniques ● Sample recognition field that can easily identify the sample and logs in the details, minimizing manual data entry. ● Barcoded labels for sample tracking ● Implemented workflow automation features for reduced confusion and increased productivity 4

5. PREPARATION & METHOD EXECUTION ● We have predefined execution methods for sample tracking, analysis of tracking response, complaint reception, reduce the dead time, and overall to increase the efficiency of our system. ● Special features for execution such as content uniformity, dissolution, stability etc. ● Strict preparation and method execution policies like standardization, tracking of reagents, control of the environment, trainees, and equipment analysis. REPORT MANAGEMENT We understand the importance of report generation and sensitivity in handling the report data. Hence we have assembled the following features for report management: ● Instant visualization on any abnormal notifications. ● Configurable testing methodologies and calculation techniques for managing high variant products. ● Multiple level approvals with comment entries for sensitive results. 5

6. SPECIALIZED REPORTING ● Flexible facilities that are fully configurable to the product and customer level including layout, content, units, significant digits, etc. Bi-directional integration with SAP-QM or SAP Batches for finished product testing. Interfaces to other ERP/MES systems available. Streamlined delivery of event notification and results to end users via e-mail, fax, etc. ● ● DECISION REPORTING The documents like SOP, analytical, maintenance, etc. are version controlled for ISO standard compliance. 6

7. FEATURES 7

8. FEATURES As important as quality control is in laboratories, so is analyzing the proper features best suited for every laboratory and making use of it appropriately. Some important Quality control features are as follows: ● Latest and updated versions of specifications are available on request. ● Multi-level product specification management is made with controlled releases. ● Sample management, sample storage, and reserve management are all done with accuracy. ● Sample planning with the batch-wise process and test plan management is done. ● Templated sample management by templating the sample at registration is effectively carried for sample tracking. ● Quality control is done at multi-level, multi-departmental, and multi-premises. 8

9. FEATURES ● Workflow management with work schedule according to work plan for analysts and instruments alike. ● Accuracy in result capture and OOT management. ● Quality control on instruments by instrument calibration and regular maintenance scheduled at different time intervals with a proper update on status lock for instruments. ● Training on the new releases and sample management for every instrument is carried for every lab personnel ● Any deviations from the original workflow are promptly recorded and validated. ● Stability in the study module is maintained. LIMS quality control process allows managing the data of products, samples, and instruments alike on a regular basis by monitoring at various levels. This ensures that quality can be monitored and, if necessary, actions to improve quality. 9

10. ABOUT US We are passionate about Technology and we are passionate about Healthcare. With a collective experience of more than 100 years in Healthcare, Healthcare Technology, Marketing, Customer Service and Information Management, Team MocDoc has the experience and is uniquely positioned to understand and meet the challenges that are inherent in the Healthcare sector. CONTACT US +91-81898-81898 PLEASE VISIT US AT Yro Systems Private Limited, #17, 3rd Cross Street, Swamy Square, Vijayanagar, Velachery, Chennai - 600 042. Email us at - contact@mocdoc.in 10