MasterControl
Table of Contents
Introduction
MasterControl is a leading provider of quality and compliance software solutions for regulated industries, including life sciences, pharmaceuticals, and biotech. Its platform helps organizations manage quality processes, ensure regulatory compliance, and bring life-changing products to market faster and more efficiently.
Definitions and Concepts
MasterControl Quality Management System (QMS): A centralized software platform designed to streamline and automate quality processes such as document control, training management, corrective actions, and audit management.
Validation: A key feature of MasterControl that simplifies the validation process for software applications in compliance with FDA regulations, such as 21 CFR Part 11.
Regulatory Compliance: MasterControl helps organizations adhere to global regulatory standards, including FDA, EMA (European Medicines Agency), and ISO (International Organization for Standardization) guidelines.
Importance
In regulated industries like life sciences, compliance with stringent regulatory requirements is critical for product approval and safety. MasterControl simplifies quality management and compliance, ensuring that companies maintain audit readiness and meet global regulatory standards.
For pharmaceutical and biotech organizations, the software reduces the risk of noncompliance, improves operational efficiency, and enables faster time-to-market for innovative products, including drugs, medical devices, and biologics.
Principles and Methods
Document Management: MasterControl provides a secure, web-based repository for storing, tracking, and sharing critical documents. This ensures version control, prevents unauthorized access, and supports collaboration.
Training Management: The platform connects training activities to quality events (e.g., SOP changes or CAPAs), ensuring that workforce skills align with compliance requirements.
Audit and Inspection Readiness: MasterControl logs all activities in a traceable format, creating an audit trail that simplifies regulatory inspections and internal audits.
CAPA (Corrective and Preventive Action): The platform supports root cause analysis and the implementation of corrective actions to address quality issues proactively.
Risk Management: Integrated risk management tools assess the impact of changes or quality events, improving decision-making and regulatory outcomes.
Application
MasterControl is widely used across the life sciences, pharmaceutical, and biotech industries to ensure regulatory compliance and enhance operational excellence:
- Pharmaceutical Development: Facilitates compliance with FDA and global regulatory requirements, accelerates drug approval timelines, and ensures data integrity in clinical trials.
- Medical Devices: Helps organizations align with ISO 13485 standards, the FDA’s Quality System Regulation (QSR), and post-market surveillance requirements.
- Biotechnology: Supports the development of biologics by ensuring quality control in manufacturing and maintaining a compliant supply chain.
- Contract Research and Manufacturing Organizations (CROs/CMOs): Enhances collaboration and ensures compliance with regulatory requirements for outsourced projects.
- Laboratories: Streamlines quality processes and supports ISO 17025 accreditation for laboratory operations.