Laboratory Quality Management Software Systems QMSWhen is it Time to Get a Laboratory Quality Management Software System QMS The best scenario would be that the day the lab opens, a laboratory QMS is in place.Document control is essential to the safety and efficacy of a lab.Additionally, in order to comply with accreditation, laboratories must establish an effective document control system.Each document must be created, updated, approved, and archived in specific ways, or a laboratory will have deficiencies on the accrediting agencys checklist.Many laboratories keep their policies and procedures in physical binders, trying to keep up with the endless paper trail of revised standard operating procedures and policies.There are usually multiple copies of these binders in different parts of the lab, making updating these documents very time consuming and error prone.The best time to get a laboratory quality management software system may be before accreditation rolls around.The accreditation process includes a review of management systems and an assurance that a laboratory has a quality system that is documented and fully operational.An electronic document control system provides this kind of assurance.The Five Parts of a Laboratory Quality Management Software System.There are five key parts of a laboratory QMS Quality Manual.The ISOIEC 1. 70.Standard requires that the lab have writtenpolicies regarding organization, management review, document controls, contracts, purchasing, complaint handling, control of non conforming test results, corrective action protocols, audits, and continual improvement.The standard requires that the lab have written policies covering the selection and training of lab personnel, environmental conditions of the lab, test methods and validation, equipment and instrumentation, measurement traceability, method verification, sampling, as well as sample handling protocols.All of these policies are contained in the laboratory quality manual.All accreditation organizations require that some form of a quality manual exist for each lab.Staff and Training.Laboratory quality management requires that all employees performing analytical procedures must be competent and trained by quality trainers.All training must be documented.Methodology. In an LQM program, methods must be written in a consistent format through the lab.They must be validated and accessible to all users.RM in house or recognizedThis is an internal standard of quality set by the lab.Record Keeping. There are several different kinds of documentation needed for a laboratory quality management system.SOPs, calibration logs, training records, CAPAs and maintenance records are just some of the categories required.Get Your free ISO 9001 Sample Manufacturing Process Audit Checklist.For more information about ISO consulting, audiing, or training services or the customized.How Can Master. Controls Laboratory Quality Management System Benefit You Master.Controls Laboratory QMS is able to handle all five parts of the quality management system described above.The software helps sustain a laboratorys compliant status, year in and year out.The Master. Control integrated quality management suite is a configurable, easy to use solution that helps companies attain and sustain compliance with FDA and other regulations by automating and managing quality processes in an efficient and cost effective manner.Recognizing that validating a software solution and keeping it in a constant state of validation is half the battle in sustaining compliance, Master.Control is actively developing new ways to reduce the time and effort involved in validating a system and to make it easier to validate software upgrades, both of which are essential in lowering overall validation cost.To learn more about Master. How To Stop All Current Installations Windows Movie . Controls Laboratory Quality Management Software Systems QMS, contact a Master.Control representative.
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