Pharmaceutical & Biotechnology Change Control Software Systems

MasterControl offers Pharmaceutical & Biotechnology Change Control Software Systems to Comply Life Science Companies with 21 CFR Part 11 and Parts 210-211 Quality Standards

In the FDA environment, the concept of change control is closely interwoven with regulatory compliance. FDA-regulated pharmaceutical companies are expected to establish a Pharmaceutical and Biotechnology change control software systems as a way to improve product quality and safety and to ensure compliance. Under the Current Good Manufacturing Practice (CGMP) regulations outlined in 21 CFR Parts 210-211, pharmaceutical companies are required to control any change to established processes - meaning the change has to be recorded, reviewed, and approved by the quality control unit.

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The MasterControl's Pharmaceutical and Biotechnology change control software is an integrated quality management suite which is configurable and easy-to-use software solution that helps 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 full-cycle validation services for Pharmaceutical and Biotechnology change control systems, including IQ, OQ, and PQ validation tests. MasterControl continuously develops new methods 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.

Compliant With Pharmaceutical and Biotechnology Change Control Systems

Sustained Compliance:MasterControl believes that compliance is a state, not an event. MasterControl's Pharmaceutical and Biotechnology change control software is designed not only to help pharmaceutical and biopharmaceutical companies ensure FDA GMP compliance, but to sustain it year after year by automating and enforcing change control processes.

• Increased Efficiency Through Automation:MasterControl's Pharmaceutical and Biotechnology 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 increases management oversight. A Pharmaceutical and Biotechnology change control system provides the a ability 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 Pharmaceutical and Biotechnology 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's Pharmaceutical and Biotechnology change control software 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 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, you can get approval from different people without the legwork. Documents can be signed and approved electronically from the Pharmaceutical and Biotechnology change control software. Signature manifestation - name, date, time, and meaning of electronic signature - can be appended automatically to each document.

Complete Pharmaceutical & Biotechnology Change Control Systems

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 for effective Pharmaceutical and Biotechnology change control systems.

• Easy to Search: A standardized Google-like search window is available throughout the application, 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 wihthin the Pharmaceutical and Biotechnology change control systems. 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.