Many of today’s laboratories face similar problems involving manual document control and accreditation management. These labs deal with staff shortages, increasing demand for laboratory services and declining operating budgets. Additionally, many labs face additional pressures in managing and complying with accreditation requirements.
Many of today’s laboratories face similar problems involving manual document control and accreditation management. These labs deal with staff shortages, increasing demand for laboratory services and declining operating budgets. Additionally, many labs face additional pressures in managing and complying with accreditation requirements.
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One way to meet these challenges head on is to use a laboratory quality management software system (QMS). A quality management software system that is automated and connects all departments is essential for a regulated or ISO-compliant company. A QMS or a TQM (total quality management) system can connect each department in a laboratory with other departments. Automated routing, with escalation, ensures the rapid responses to inputs needed from other departments. By building quality into products as opposed to forcing QA to bear the burden of the responsibility, everyone (engineering, regulatory, QA, manufacturing, sales and marketing) wins.
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 agency’s 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.
There are five key parts of a laboratory QMS:
The ISO/IEC 17025 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.
Laboratory quality management requires that all employees performing analytical procedures must be competent and trained by quality trainers. All training must be documented.
In an LQM program, methods must be written in a consistent format through the lab. They must be validated and accessible to all users
This is an internal standard of quality set by the lab
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.
MasterControl’s Laboratory QMS is able to handle all five parts of the quality management system described above. The software helps sustain a laboratory’s compliant status, year in and year out. The MasterControl 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, MasterControl 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 MasterControl’s Laboratory Quality Management Software Systems (QMS), contact a MasterControl representative.
MasterControl Inc. and its partner, i4DM, are expanding their FDA project, serving as the QMS providers for a second FDA division. The two companies have been the QMS providers for the FDA's Office of Regulatory Affairs since 2009. Now they will also serve as quality providers for the Division of Pharmaceutical Analysis, which is part of the FDA's Center for Drug Evaluation and Research.
To learn more about MasterControl's software systems, please contact a MasterControl representative.
