Clinical Laboratory Improvement Amendments ( CLIA ) require the establishment, performance, documentation, and evaluation of a clinical laboratory's quality control procedures which can be achieved from laboratory document control software systems. In addition, laboratories that are regulated by the FDA must comply with quality control requirements that apply to them, such as those found in 21 CFR Parts 820, 606, and 210-211. FDA-regulated labs that use electronic record-keeping systems to comply with predicate rules also must meet requirements under 21 CFR Part 11, which calls for document and other controls.
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Prior to 1988, laboratory tests were not regulated. Since then, the medical industry has become vastly dependent on the accuracy of tests. Congress passed the CLIA - Clinical Laboratory Improvement Amendments (42 CFR 493), which provides established standards for laboratory testing by ensuring accuracy and reliability of patient test results. According to CLIA, any facility that performs testing of human specimens must comply with CLIA standards and obtain a certificate from the Department of Health and Human Services. Since any laboratory is counting on presenting accurate test results to its patients and customers, laboratory document control software systems become essential for those organizations seeking to comply with CLIA and FDA regulations.
To control quality, one must control quality documentation. Controlling quality documentation requires an effective laboratory document control system.
MasterControl's laboratory document control software is a quality management suite, available through the Internet for access through authorized users across the globe. The main aim of MasterControl's laboratory document control software is to help laboratories attain and sustain FDA and CLIA compliance. The software helps in sustaining FDA compliance by providing a solution that presents full-cycle validation, including IQ, OQ, and PQ validation tests. MasterControl continuously develops new methods to cut the time involvedin validating a laboratory document control system and makes it easier to validate software upgrades, both of which are essential in lowering overall validation cost.
Clinical and medical labs my find it a difficult task to tackle their documents and standard operating procedures in real-time situations. In efforts to have processes that are validated, there are many factors that may limit transparency and automation in the way tests are carried out in these labs. This is where MasterControl Documents comes to rescue by providing an advanced web-based laboratory document control software solution that helps clinical and medical labs attain and sustain FDA and CLIA document control compliance.
Here's how MasterControl Documents addresses some of the major challenges that medical and clinical laboratories face in establishing and maintaining a laboratory document control system that complies with CLIA, FDA CGMPs, and 21 CFR Part 11.
As companies grow larger and expand their business to multiple locations, it becomes more and more difficult to maintain paper-based or hybrid laboratory document control systems. These systems require tremendous effort to route documentation, obtain approval signatures, facilitate face-to-face meetings to discuss changes, and allow for manual retrieval of documents during FDA and ISO inspections or audits.
MasterControl laboratory document control software automates routing and delivery of SOPs, policies, and other documentation for streamlined document control. MasterControl is uniquely qualified to be the focal point of a quality management system because it can handle all types of documents regardless of the software used to create them. Our laboratory document control software provides a secure and centralized document control repository that makes search and retrieval easy during inspections and audits. MasterControl Documents is web-based so documents are accessible to all authorized users from virtually anywhere.
Paper-based laboratory document control systems can create a communication breakdown because of separate document control processes across departments and locations. It can be tedious to cross-communicate within the organization as every department keeps a separate copy of their documents. This can lead to a risk of variance in the way processes are understood and carried out in the lab. Ineffective communication can lead to delays and non-adherence to CLIA and FDA regulations.
MasterControl Documents is an integrated solution that connects all quality sub-systems like CAPA, change management, audit, customer complaint, and training. For example, a customer complaint that warrants a CAPA will be immediately escalated. Any CAPA that results in a change will automatically invoke training once the change is approved. MasterControl systems are web-based, integrated solutions that can be customized and used by all departments and locations; even different business units.
Providing Document Revision Control with Laboratory Document Control Software in a paper-based system or hybrid system, employees check out documents and other materials (engineering drawings, etc.) manually. Tracking down any document activity is difficult. Making a change in an SOP or other document requires manual submission of a change request or discussion of the change in face-to-face meetings.
One of the objectives of any medical or clinical laboratory is to maintain a repository of policies and procedures. Without this, the system becomes inefficient in carrying out tests which lack quality and standard. CLIA section 493.1200 emphasizes the documentation of all procedures that implement and monitor quality systems. MasterControl Documents helps in automating, routing, escalating, approval and delivery of all SOPs, policies, and other related documentation. The centralized web-based repository is available only to authorized users. One of the pivotal features is to automate revision control to ensure that only authorized users are able to change the documents. Before changes are recorded in the laboratory document control system, the software prompts the user to enter the reason for alteration. Furthermore, the tracking facility helps in tracing the changes made to documents. This helps any user in finding the updates and makes the reviewing of documents convenient for the concerned personnel.
It's difficult to generate accurate and timely reports and trends using disparate tools (electronic spreadsheets, flowcharting software, paper documents in binders, etc.). Without an effective reporting tool, managers are unable to get control of their quality management system.
MasterControl's laboratory document control software systems provide advanced analytics and reporting capabilities, including customizable reports and online charting. Through the reports, managers get a real-time view of the quality processes and can be more proactive about improving their quality system.
Additional Features: MasterControl's laboratory document control software systems dramatically reduce the time it takes to bring a new product to market by speeding up the process for document change, approval, notification, and distribution
For additional details about the laboratory document control software systems from MasterControl, please feel free to contact a MasterControl representative.