Contract Research (CRO) Training Software Systems

Contract Research (CRO) Training Software Systems are Web Software for Automating Employee Training Requirements Specific to 21 CFR Part 211, 820 Regulations, and ISO 13485 Quality Standards

MasterControl offers integrated contract research training software in a configurable and easy-to-use software solution that helps contract research organizations attain and sustain CGMP compliance and ISO conformance. Recognizing that validating a software solution ( as required by 21 CFR Part 11 ) is a necessary component in FDA compliance, MasterControl offers comprehensive, full-cycle validation services, including IQ, OQ, and PQ validation tests. MasterControl continuously develops new methods for CRO training systems to cut the time involved in validating a system and to make it easier to validate software upgrades, both of which are essential in lowering overall validation cost.

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Compliant CRO Training Systems

Sustained Compliance: MasterControl's CRO training software not only helps ensure compliance with ISO training requirements, but helps sustain it by strengthening the training control process, promoting efficiency, and keeping training documentation always ready for ISO audits

• Increases Efficiency for Sustained Compliance: CRO training systems automate assignment, monitoring, and verification of training tasks. Users are automatically notified when they have new training tasks. A link points directly into the user's My Task box.
• Proof of Competency: Automates grading of online exams, which you can use as proof of personnel competency.
• Centralized Repository: A contract research training system stores all training records in a secure, centralized repository, making it easy to search and retrieve them during a compliance inspection or a customer audit.
• Advanced Training Tracking: MasterControl's contract research training systems track training tasks by status or history. A document will show as either in process or complete if tracked by status. The revision or approval history of documents can also be reviewed using the history feature.
• Random Exam Questions: Courses that require an exam can be configured so there will be a pool of questions prepared in advance from which the exam can pull questions randomly. This will ensure that a user who has failed the exam will not get the same questions in the same order during his/her second try.
• Optional Training Verification: For basic courses that don't require verification, MasterControl's contract research training system allows training tasks to be configured to bypass it, greatly streamlining the process and reducing the burden on supervisors, who typically act as verifiers.
• Document's Effectivity Tied to Training Completion:A course can be configured so that the associated document only becomes effective after all required trainees have completed the course.
• More Timely Verification: Assigning a "course verifier" role allows sending the verification task to multiple users. When a certain supervisor is not available to verify a training task, another verifier can do it to ensure timely verification within the CRO training system.
• Analytics and Reporting: MasterControl's advanced analytics and reporting capability of the CRO training system provides standard and customized reports to show the status of a training program. The system tracks and shows any training deficiencies that might jeopardize compliance. MasterControl includes dashboard, drill-down, and scheduling capabilities.
• Revision Control: MasterControl Training provides revision control to ensure that only current training courses are available.

Connected CRO Training Software

Integrated Quality Management: MasterControl's CRO training software integrates the training process with other quality processes for a holistic approach to quality management.

• Easy Access: MasterControl's contract research training software is Web-based so it can connect trainees, trainers, verifiers, and the training coordinator regardless of location.
• Integration of Training with CAPA: CRO training software seamlessly integrates with corrective and preventive action (CAPA) process for a more efficient and effective system. For example, a CAPA that causes a change in product design or function will invoke training tasks upon approval of the change.
• Training Linked to Change Control: If there's any change in a document linked to a required course because of a revised SOP or policy, all affected trainees will immediately receive new training tasks.
• Sequencing of Courses: Contract research training software allows implementation of a progressive training program by sequencing training courses. Once a prerequisite is completed, the next course is automatically launched.
• Streamlines Collaboration: Creating, revising, and approving training courses as a team is easier because MasterControl's CRO training software provides a collaboration workspace that allows a user to see other people's input, avoiding duplication. A rejected document is automatically returned to the originator for a new task, so rejected packets don't languish in the system.
• Integrates with Other Applications: MasterControl's CRO training software integrates with other applications like Enterprise Resource Planning ERP, Laboratory Information Management System LIMS, accounting, and human resources applications to accommodate departmental needs.

Complete Contract Research Training Software Systems

Enterprise-wide Product Application: MasterControl can meet every department's training control and other quality-related needs, making it an ideal enterprise-wide solution. And, MasterControl offers robust contract research training software, plus the appropriate tools and services necessary for successful implementation and validation.

• Continuous Validation:For FDA-regulated companies, MasterControl offers a "continuous validation" approach built in the CRO training software that dramatically cuts the time, pain, and cost involved in validation. MasterControl's continuum of innovative products and services include MasterControl Transfer OQ and MasterControl Automated OQ.
• Product Training: MasterControl's Professional Services team, consisting of former ISO auditors and system administrators, has developed a comprehensive training program that serves as a foundation for successful project implementation and helps companies realize software ROI faster. The team conducts training at MasterControl's state-of-the-art Training Center in Salt Lake City and also at customers' facilities.
• Unmatched Technical Support: Choosing MasterControl means getting the necessary technical support to ensure project success. MasterControl offers the expertise, infrastructure, and flexibility within contract research training system to meet every customer's needs, from initial installation to regular maintenance.
• Pre-Defined Workflow: Training courses on company-wide policies, SOPs, and other documents move along a pre-defined workflow, from one department to the next. Overdue tasks automatically escalate to a manager.
• Group Sign-Off: MasterControl's CRO training systems can handle training courses that involve the entire company or a big part of the organization. It provides a group sign-off feature for verifying training of large groups of employees.
• Easy to Search: A standardized "Google-like" search window is available throughout the application, which means all authorized users throughout the organization can search for tasks, training records, policies, and other documents using a familiar search interface.
• 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 in the contract research training software. 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.

For More Information on Contract Research (CRO) Training Software Systems

For more information about contract research (CRO) training software systems, please feel free to contact a MasterControl representative.