Contract Research (CRO) Training Software Systems are Web Software Solutions that Automate Required Employee Training Programs 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 contract resource organizations training software 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.
Due to the nature of their businesses, regulated companies need a CRO training software system that includes all the tools necessary for successful implementation and streamlined software validation. The system must be maintainable in a constant state of audit readiness and it must be able to drastically reduce the amount of time and trouble typically required for system validation.
If your contract research organization is searching for a training software system that better help you meet regulatory requirements, there are several key factors that need to be taken into account:
Efficiency: Does the system you are considering efficiently automate the routing, tracking, and follow-up of training tasks? Does it offer automatic grading of exams given online?
Notification: How are users notified about new training tasks? When a task is completed, is the verifier/verifiers automatically notified?
Connectivity: How well does the system integrate training processes with the rest of the quality system? Does it offer a holistic approach to management? For instance, if there is a change to a document that is linked to a required course because of a revised standard operating procedure, do all affected trainees automatically receive a new training task from the system?
Visibility: Does the system offer analytics and reporting capabilities that include customizable reports, online charting, and/or gap analysis?
Compliance: Are training control processes optimized and is training documentation maintained in a centrally available repository for reviews or inspections that may be held at any time?
MasterControl’s Approach to Software Implementation and Validation
In order to be a true “solution,” training software must be applicable throughout the entire enterprise. As such, MasterControl is designed to meet the training needs of all departments participating in and affected by quality processes. And, to support its robust contract research training software systems, MasterControl offers all the services necessary for successful implementation and validation, making it the ideal enterprise-wide solution. With companies subject to regulatory requirements in mind, MasterControl takes a “continuous” validation approach to CRO a training software system that dramatically cuts the time, pain, and cost required for validation. Two primary components of MasterControl’s unique continuum of innovative validation offerings, MasterControl Transfer OQ and MasterControl Automated OQ, are particularly useful for organizations that have to minimize the validation drain on company resources.
Features and Benefits of the MasterControl CRO Training Software System
Sustained Compliance Achieved through Automation: 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. The assignment, monitoring, and verification of training tasks are all completely automated. Proof of personnel competency can be easily verified through the automatic assignment and grading of online exams. 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.
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.
Integrating Training with All Quality Processes: 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. 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.
Advanced Training Tracking: MasterControl's contract research training systems track training tasks by status or history. A document will appear as either being in process or complete if tracked by status. The revision or approval history of documents can also be reviewed using the history feature. 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. A course can also be configured so that the associated document only becomes effective after all required trainees have completed the course.
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.
Robust Analytics and Reporting: MasterControl's advanced analytics and reporting capabilities feature 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.
Streamlined 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.
Integration 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.
Unmatched Technical Support: Choosing MasterControl means getting the necessary technical support to ensure project success. In addition to superior software, MasterControl offers the expertise, infrastructure, and flexibility to meet every customer's needs, from initial installation to regular maintenance.
For More Information on Contract Research (CRO) Training Software Systems
MasterControl Inc. and its partner, i4DM, are expanding their FDA project, serving as the QMS providers for a second FDA division. The two companies have been the QMS providers for the FDA's Office of Regulatory Affairs since 2009. Now they will also serve as quality providers for the Division of Pharmaceutical Analysis, which is part of the FDA's Center for Drug Evaluation and Research.