Biotechnology & Pharmaceutical Training Software Systems
MasterControl offers Biotechnology & Pharmaceutical Training Software Systems, a Web Based Software to Automate FDA GMP 21 CFR Part 211.25 - 210 Compliant to Personnel and Employee Training Processes
The MasterControl's biotechnology & pharmaceutical training software is an integrated quality management suite which is a configurable and easy-to-use software solution that helps biotech companies 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 comprehensive, full-cycle validation services, including IQ, OQ, and PQ validation tests. MasterControl continuously develops new methods and biotechnology and pharmaceutical training ystems 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.
MasterControl's biotechnology and pharmaceutical training software is an integrated part of the MasterControl quality software suite which automates training management processes in an efficient and cost-effective manner.
Why is Biotechnology and Pharmaceutical Training Systems Right for You?
MasterControl Training, an integrated part of the MasterControl quality software suite, automates biotechnology and pharmaceutical training systems in an efficient and cost-effective manner. Here are some of its robust features to help ensure your training management system is always compliant, connected, and complete:
Compliant Biotechnology and Pharmaceutical Training Software
Sustained Compliance: MasterControl's biotechnology and pharmaceutical training software not only helps ensure compliance with CGMP and ISO training requirements, but helps sustain it by strengthening the training control process, promoting efficiency, and keeping training documentation always ready for FDA inspections and ISO audits.
Increases Efficiency for Sustained Compliance: Automates 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: Biotechnology and pharmaceutical training software automates grading of online exams, which you can use as proof of personnel competency.
Centralized Repository: All training records will be stored 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 tracks training tasks by status or history in the biotechnology and pharmaceutical training software. 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. A biotechnology and pharmaceutical training system 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, training tasks can be configured to bypass it, greatly streamlining the process and reducing the burden on supervisors, who typically act as verifiers.
Document's Affectivity Tied to Training Completion: A course can be configured within the biotechnology and pharmaceutical training software 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.
Analytics and Reporting: MasterControl's advanced analytics and reporting capability provides standard and customized reports to show the status of a training program. A biotechnology and pharmaceutical training 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 Biotechnology and Pharmaceutical Training Systems
Integrated Quality Management: MasterControl integrates the biotechnology and pharmaceutical training system with other quality processes for a holistic approach to quality management.
Easy Access: MasterControl's biotechnology and pharmaceutical training system is web-based so it can connect trainees, trainers, verifiers, and the training coordinator regardless of location.
Integration of Training with CAPA: 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: A biotechnology and pharmaceutical training system 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 provides a collaboration workspace within the biotechnology and pharmaceutical training system 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 biotechnology and pharmaceutical training systems can integrate with other applications like Enterprise Resource Planning ERP, Laboratory Information Management System LIMS, accounting, and human resources applications to accommodate departmental needs.
Complete Biotechnology and Pharmaceutical Training Software
Enterprise-wide Product Application: MasterControl can meet every department's training control and other quality-related needs, making it an ideal enterprise-wide solution with the help of its biotechnology and pharmaceutical training software. And, MasterControl offers robust 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 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 biotechnology and pharmaceutical training software 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 to meet every customer's needs, from initial installation to regular maintenance.
Integrates with Other Applications: MasterControl's biotechnology and pharmaceutical training software can integrate with other applications like Enterprise Resource Planning ERP, Laboratory Information Management System LIMS, accounting, and human resources applications to accommodate departmental needs.
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 can handle training courses that involve the entire company or a big part of the organization with the implementation of biotechnology and pharmaceutical training software. 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 biotechnology and pharmaceutical training software, 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 in the biotechnology and pharmaceutical training software can be stored in multiple Organizers. 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 direct from biotechnology and pharmaceutical training software.
To Learn More About Biotechnology & Pharmaceutical 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.