Clinical & Medical Laboratory Change Control Software Systems

FDA GMP for Clinical & Medical Laboratory Change Control Software Systems by MasterControl

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 MasterControl offers clinical and medical laboratory change control software. 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.

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The MasterControl's clinical and medical laboratory change control systems is an integrated quality management suite which is configurable and easy-to-use software solution that helps blood establishments attain and sustain CGMP compliance. Recognizing that validating a software solution (as required by 21 CFR Part 11) is a necessary component in FDA compliance, MasterControl offers full-cycle validation services, including IQ, OQ, and PQ validation tests. MasterControl continuously develops new methods to cut the time involved in validating a clinical and medical laboratory change control system and to make it easier to validate software upgrades, both of which are essential in lowering overall validation cost.

How can Clinical and Medical Laboratory Change Control Software Benefit You?

MasterControl clinical and medical laboratory change control software is software designed to help clinical and medical labs automate and effectively manage every step of the change control process, from submission through actual implementation, verification, and close of project.

Compliant With Clinical and Medical Laboratory Change Control Systems

Sustained Compliance: MasterControl believes that compliance is a state, not an event. MasterControl's clinical and medical laboratory change control system is designed not only to help labs comply with FDA regulations, but to sustain it year after year by automating and effectively managing change control processes.

• Increased Efficiency Through Automation:MasterControl's clinical and medical laboratory change control software automates all tasks pertaining to change control, including notification, follow-up, and escalation of overdue assignments. Automation helps simplify the compliance environment, making it easier to stay compliant.

• Best-Practice Form:A pre-configured, multi-page form helps collect and track data every step of the way in the change control process: submission, evaluation, approval/ rejection, implementation, verification, and close of project.

• Analytics and Reporting: MasterControl's advanced analytics and reporting capability in the clinical and medical laboratory change control software increases management oversight. It provides the a bility to dynamically capture, trend, and link data needed to solve problems and improve processes. Data can be summarized in multiple levels, so change orders can be reported by product, department, root cause, etc.

• Revision Control: While the current document is still available to the intended audience, authorized users may check-out and collaborate with others to make revisions to draft documents. 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.

Connected Clinical & Medical Laboratory Change Control Software Systems

Integrated Quality Management: MasterControl connects the change control process with other quality processes for a holistic approach to quality management.

• Easy Access: MasterControl Change Control is Web-based so it can connect employees, suppliers, contractors, consultants, and others involved in the change control process regardless of location.

• Form-to-Form Launching: A change submission form can be launched directly from another form, such as a corrective/preventive action (CAPA) form. Pertinent information from the CAPA form will be automatically entered into the change submission, reducing data entry. Links are maintained so users can review a completed process and see what triggered the change.

• Dependent Routing: Completion of a task can be made dependent on another task in the clinical and medical laboratory change control software to give managers more control of the workflow and reduce cycle time by prompting users immediately to their next task. An innovative dependency tree illustrates relationships between dependent processes.

• Electronic sign-offs: With MasterControl's clinical and medical laboratory change control systems, you can get approval from different people without the legwork. Documents can be signed and approved electronically. Signature manifestation - name, date, time, and meaning of electronic signature - can be appended automatically to each document.

Complete Clinical and Medical Laboratory Change Control Software

Enterprise-wide Product Application: MasterControl can handle every department's forms and documents-based processes, making it an ideal enterprise-wide solution.

• Integrates with Other Applications: MasterControl can integrate with other applications like ERP, LIMS, accounting, and human resources applications to accommodate departmental needs.

• Easy to Search: A standardized Google-like search window is available throughout the application in the clinical and medical laboratory change control software, which means all authorized users throughout the organization can search and retrieve change control-related tasks and documents.

• Easy to Find: MasterControl's Organizer, similar to Windows Explorer, is an easy-to-use tool that helps users find and access documents quickly. Every department can maintain its own Organizers and documents can be stored in multiple Organizers. Clinical and medical laboratory change control system administrators can control and automatically update the documents through a dynamic link in the InfoCard.

• Automation of Forms-Based Processes: Any forms-based process unique to a department (i.e., application forms for HR, customer satisfaction survey forms for Customer Service Department) can be automated. A department can keep the look and function of existing forms or create entirely new ones.