OSHA Regulation 29 CFR Part 1904 outlines stringent requirements that employers must meet in regards to the tracking and reporting of work-related injuries, illnesses, and fatalities. Severe fines can be imposed on companies that do not report or appropriately investigate work-related accidents and injuries. The MasterControl Accident/Injury™ solution has been specifically designed to help companies comply with OSHA Regulation 1904 and also effectively and efficiently manage accident reporting and injury reporting.
MasterControl's Bill of Materials Systems are designed by industry practitioners for automating the BOM process in any organization. A BOM system is the crux of any quality and compliance process. It is a regulatory requirement that FDA / global regulatory inspectors and ISO auditors consider critical. An automated BOM system reduces audit time and findings, and decreases risk of product recalls. It improves product quality and safety, increases customer satisfaction, and ensures FDA and ISO compliance.
Deviation Management Software Systems by MasterControl helps in Automating and Integrating Deviations Management Processes FDA-Regulated and ISO-Quality Environments. It automates manual quality processes and facilitates compliance with GMP regulations that require formal deviation control such as 21 CFR Part 211 for pharmaceutical companies and 21 CFR Part 820 for medical device firms. More and more life sciences and other regulated companies rely on deviation management software to digitize their quality processes for compliance purposes.
Manufacturing and laboratory equipment such as instruments, apparatus, gauges and recording devices directly impact the quality and safety of finished product. Therefore, equipment calibration tasks are essential to a company’s quality management and regulatory compliance, with the U.S. Food and Drug Administration (FDA) mandating routine calibration of such equipment along with the retention of calibration records. MasterControl equipment calibration software helps automate and manage these calibration tasks to improve quality and compliance and minimize downtime.
An integral part of quality management is the ability to capture quality events as a starting point for containment, corrective action, and preventive action. Examples of such defined quality events include: Nonconformances, Deviations, Variances and Customer Complaints. Other issues and observations may occur that do not fit any of these categories with the consequence of either being ignored or fed into one of these event handling systems regardless of suitability. In the first case, quality-related information is lost, and in the latter the handling system may become clogged and slowed down. Learn More 
The FDA’s medical device reporting (MDR) regulation 21 CFR Part 803 requires device manufacturers to report to the FDA any deaths or serious injuries as well as certain malfunctions associated with their devices. MasterControl Inc. offers an electronic medical device reporting (eMDR) software solution that enables MasterControl users to implement their FDA adverse event reporting process electronically.
Regulated environments require that materials and products conform to certain specifications. When they don’t, nonconformance management software is used to detect, evaluate, review and handle those issues.Nonconformance Management Software Systems Integrates Nonconformance, CAPA, and other Quality Processes to Ensure Compliance with FDA Regulations and ISO Quality Standards.
Good Manufacturing Practice (GMP) regulations require pharmaceutical, medical device and other regulated manufacturers to conform to approved specifications that define the parameters for a product to be considered safe. Many companies rely on out of specification software to help them investigate and resolve OOS incidents.
A consistent approach in assessing and managing risk is crucial to successful quality management. MasterControl's risk management software system is an integrated solution to help companies identify and mitigate long term systemic risks by tracking and analyzing the recurrence of issues. MasterControl Risk™ is a "one-stop shop" that unifies all risk-related activities and documentation in a single, centralized repository. The MasterControl risk management software system provides a complete and accurate picture of the risk landscape across product lines, business processes, and business units, precluding reputation damage from recalls or regulatory action.Copyright © SeerPharma
