A medical or clinical laboratory runs tests to provide information about a patient's health. Usually, these tests are conducted by technicians under the supervision of pathologists which means that processes in the laboratory must be organized. In order to efficiently run tests, medical and clinical laboratories must constantly audit their systems. For this reason, MasterControl provides medical and clinical laboratory audit software that effectively automates and manages the medical and clinical audit processes.
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Medical and clinical laboratories in the US understand the importance of attaining compliance with FDA and CLIA regulations. These regulations define the requirements for practicing business and the standards to which a laboratory must follow. With MasterControl's clinical and medical laboratory audit management system, laboratories attain and sustain FDA and CLIA compliance through the easy-to-use and highly configurable audit management software. Audit is a necessary tool for examining different internal process areas. Understanding the need to schedule audits on a timely basis helps laboratories excel in their fields. Since medical and clinical laboratories work in a life-sensitive environment, any miscalculated test result can yield harmful repercussions. This is why laboratories must run iterative audits to constantly examine their processes and bring improvement to their overall infrastructure.
As per FDA 21 CFR Part 11, it is important to validate a software solution. MasterControl Transfer OQ (in the form of transfer operational qualification or TOQ) provides complete validation and supporting documentation of IQ/OQ tests performed at MasterControl. This documentation serves as evidence that the functions of a MasterControl application perform correctly against specifications. Instead of validating the software at company's cost and expense, MasterControl medical and clinical laboratory audit management software reduces overall validation burden and is a key component of MasterControl's continuous validation approach.
The following sections describe the advantages of incorporating MasterControl's medical and clinical laboratory audit management system that automates, streamlines and effectively manages quality audits in the business.
The main purpose of an audit is to track findings that help in tracing deviation in processes. In a medical and clinical laboratory audit management system, tracking audit findings is a cumbersome task. Such a system requires constant human intervention to closely monitor the audit. Manual audits require a greater investment in human resources for conducting audits that may not be very accurate. Such errors will not help correct problems in the system but may instead introduce business risk. However, with MasterControl's medical and clinical laboratory audit management software, management is provided with a centralized repository for storing all audit documentation. Internal and external audits are facilitated with quick search and retrieval of documents. Any findings are tracked to specify which process area is causing an issue in the system. Audits are divided in concrete steps from scheduling, planning, execution and completion. This makes the tracking an easier task. It offers best-practice audit forms for tracking basic audit information (scope, checklists, audit team, audit status, etc.) and information for each finding. It can be integrated with the CAPA process to track related CAPAs.
As medical and clinical laboratories are constantly conducting tests that may be intricate in nature, different employees may be grouped together in a team. Follow-up tasks and assigning work can be difficult through email or phone. As there is no definite way of tracking tasks through these mediums, it is likely that a team member may not be properly informed about his or her task. With MasterControl clinical and medical laboratory audit management software, assignment and following-up of tasks is automated through e-mail notification. If a task exceeds its deadline, it is escalated for inquiry so that no employee overlooks a responsibility.
Audits are iterative in nature. This helps in examining different business areas and identifying weaknesses for business improvement. Management can run different types of audits, such as internal, customer, and compliance, on various frequencies in the system. Audit frequency depends on the size of the company and nature of business. Since medical and clinical laboratories deal in life sciences business, it is important to conduct frequent audits. So, it is likely that multiple audits may run simultaneously or on overlapping schedules. In a manual system, scheduling audits can be difficult. However, with MasterControl medical and clinical laboratory audit management software, all audit-related activities are automatically scheduled. This feature also allows planning and scheduling of tasks well in advance to eliminate risk of overlooking any task. To show relationship between dependent processes, the software provides an innovative dependency tree.
Many companies rely on disparate tools such as electronic spreadsheets, flowcharting software and paper documents in binders to generate reports. However, these reports are inaccurate and don't reflect the actual condition of the business. With MasterControl medical and clinical laboratory audit management system, management can get a complete picture of their audit program. The software provides advanced analytics and reporting capability, including customizable reports and online charting. Through the reports, managers get a real-time view of the audit process and can be more proactive about improving their quality system.
For more information about medical and clinical laboratory audit management software systems, please feel free to contact a MasterControl representative.