FDA/ISO Compliance Toolkit

The Food Safety and Modernization Act (FSMA) put stricter regulations in place that increased demands on your company’s quality management system (QMS).

Address the challenges most medical device manufacturers experience during the device history record (DHR) process when they aren’t properly leveraging an electronic DHR (eDHR) system.

MasterControl offers this collection of resources to help pharma manufacturers on their path to paperless.

MasterControl Registrations for eCTD is a cloud-based solution designed to streamline content generation and the collection and management of artifacts required for regulatory submission.

MasterControl Spark™ is a cloud-based, turnkey quality management system (QMS) solution designed specifically for regulated startups and small companies to be proactive with quality management.

This FDA Readiness Toolkit is designed to help medical device manufacturers simplify compliance with FDA standards and streamline quality-related processes.

Management of a clinical study must incorporate not only all the activities and records that comprise a study, but the capacity to efficiently assess status and development shifts at any given time.

Registering products with the FDA in the United States or other regulatory bodies overseas is a key challenge for medical device companies.

This toolkit offers informative white papers, videos, case studies, data sheets and more to help IT teams achieve a smooth, trouble-free EQMS installation.

This useful toolkit offers you more than 15 educational downloads, including a worksheet to help you calculate ROI, and proves how an EQMS helps companies accelerate compliance and speed to market.

A collection of related videos, whitepapers, articles, and product data sheets to simplify compliance with FDA standards by streamlining quality-related processes.

This FDA Readiness Toolkit is designed to help pharmaceutical companies simplify compliance with FDA standards and streamline quality processes.

To ensure the formation of efficient and compliant supplier management programs, MasterControl developed this Supplier Toolkit to improve the way suppliers and vendors are managed.

To ensure the formation of efficient and compliant supplier management programs, MasterControl developed this Supplier Toolkit to improve the way suppliers and vendors are managed.

The experts at MasterControl created this Training Toolkit that provides all the materials a company needs to develop an efficient and compliant training program.

MasterControl’s Documents Toolkit is a collection of useful videos, white papers, data sheets and other helpful documents designed to help companies develop efficient document management systems.

MasterControl’s EQMS automates, streamlines and connects all quality processes to help you accelerate speed to market, reduce costs, improve efficiency, minimize risk and ensure compliance.

A CAPA program embodies the practices and processes that both FDA inspectors and ISO auditors consider singularly critical.

Quality audits are required on an ongoing basis to help improve product quality and safety and, for some companies, to ensure regulatory compliance.

If your company is planning to convert to an automated system for managing documents and processes, make sure the new system meets the needs outlined in this 21 CFR Part 11 Compliance Checklist.