In the FDA environment, the concept of change control is closely interwoven with regulatory compliance. Clinical and medical laboratories covered by such FDA regulations as 21 CFR Parts 820, 606, and 210-211 are expected to establish a change control procedure as a way to improve product quality and safety - and to ensure compliance. Labs also must comply with change control requirements found in the Clinical Laboratory Improvement Amendments (CLIA), which provide that any modification in quality procedures must be approved, signed, and dated by the laboratory director before use. MasterControl offers clinical and medical laboratory change control software systems to facilitate labs' compliance with regulatory requirements.
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Those working in clinical and medical laboratories understand the vital importance of change control as it is extensively used in drafting documentation that directly impacts standard operating procedures (SOPs). As a part of the overall quality management system, a change control procedure is primarily written to illustrate the approved changes on the existing SOPs. These changes must be strictly adhered to, which is why management broadly publishes the changes on an enterprise level. It is important to develop an effective change control procedure lifecycle to allow for rapid changes, approvals, and implementation of changes.
Clinical and medical laboratories are dealing in the business of human lives, which makes it extremely sensitive for test results to be accurate and free of errors. A single instance of an error can lead to a different outcome of a clinical trial: an incorrect diagnosis of a patient can cause harm or loss of a life, spending thousands of dollars on faulty measures may ultimately cause significant loss of revenue and, in severe cases, mistakes may lead to the loss of practicing license or production shutdown. Therefore, it is important to "control" changes and avoid violations of guidelines outlined in various sections of the QS regulation including 820.30, 820.40, 820.70, 820.75, and 820.181. Clinical and medical laboratory personnel are aware of the necessity of stringent adherence to FDA and ISO regulations that make it all the more important to develop and manage change control procedures in a transparent environment.
MasterControl Laboratory Change Management Software allows labs to develop a flawless change control system that accommodates small, medium, or large-scale companies without any difficulty.
Clinical and medical laboratories are highly reliant on compliance with FDA regulations such as section 820.30 that strictly emphasize design controls. Another crucial guidance on document control, section 820.40, provides a basis for approving and implementing the changes made to the SOPs in the system. MasterControl clinical and medical laboratory change control software ensures that each change pertaining to process, device, labeling, packaging, or any other related procedure is thoroughly verified and validated by the appropriate department and the concerned reviewer within the department. The MasterControl software system automates all tasks pertaining to change control, which makes it easier to push forward documents for approval with the help of electronic notifications, follow-ups, and escalation of overdue assignments.
To ensure that documents remain updated and that only the most recent version of any document is consulted by the appropriate teams, the MasterControl clinical and medical laboratory change control software system "checks out" files to ensure other users are unable to access or alter files during the time they are checked out. Upon completion, the system's lifecycle management functionality automatically sends the updated copy through an approval route, impacted users are trained on changes, and the newly approved version bumps the obsolete document to archive status where retention rules come into effect.
The majority of medical and clinical laboratory procedures are dependent on interaction between users, stakeholders, vendors, and employees. MasterControl clinical and medical change control management software is entirely web-based, allowing various users to come together on a common platform to share and exchange ideas. Regardless of location, all authorized users can remain connected and collaborate in change control processes from virtually anywhere. The system's electronic signature feature allows concerned personnel and managers to sign and electronically approve documents, saving valuable time otherwise wasted on manually dispatching documents or waiting for approval. Each document can also be appended with a name, date, and meaning of the electronic signature.
Along these same lines, MasterControl clinical and medical laboratory change management software systems allow for dependent routing through which a task's completion can be tracked and closely monitored. .This provides managers more control over the workflow and reduces cycle times by prompting users immediately to complete one task and move on to the next. An innovative dependency tree illustrates relationships between dependent processes.
Irrespective of the size of the company, MasterControl can handle every department's forms and documents-based processes, making it an ideal enterprise-wide solution. Because change control procedures require comprehensive document search capabilities MasterControl offers a familiar Google-like search window for simplified search and retrieval of change control-related tasks and documents. Moreover, finding and accessing documents is facilitated through Organizers that are provided to each department for their own documents and simplify cross-departmental collaboration and enhance visibility. Administrators can update documents within these Organizers through a dynamic link in the InfoCard.
To accommodate change control procedures in various departments, MasterControl clinical and medical laboratory change control software systems can be easily integrated with other applications including ERP, LIMS, accounting, and human resources applications. Any forms-based process unique to a department (i.e., application forms for HR, customer satisfaction survey forms for Customer Service Department, etc.) can be automated. A department can keep the look and function of existing forms or create entirely new ones, all of which can be accessed and collaborated upon by appropriate personnel.
To learn more about Clinical & Medical Laboratory Change Control Software Systems, please feel free to contact a MasterControl representative.