Automating Change Control Processes in FDA Regulated Environments White Paper

The release of FDA's most recent guidance, ?Quality Systems Approach to Pharmaceutical Current Good Manufacturing Practices (CGMP),? reinforces the importance of implementing an effective change control process as a critical component in an overall quality system. However, most organizations do not take advantage of today's technology relying upon manual systems or antiquated technology to handle this significant regulatory required process.

The white paper will focus on how automated change control processes help increase efficiency, ensure compliance with FDA requirements and improve profitability.  The paper will detail specific capabilities FDA-regulated companies need when choosing a quality system in order to properly automate change management and change control processes to be in compliance with GxPs and 21 CFR Part 11. These capabilities include:

--Compliance management--Document management
--Revision control and change management
--Intuitive systems administration
--Usability for general users or viewers
--Technology built within industry standards
--Complete implementation, training and validation tools

Watch Videos How MasterControl Makes Your Job Easier (3:50) Creating a Paperless Process Using MasterControl (3:38)

Downloads:

	White Paper: Change Control - Quality Improvements in FDA and ISO Environments
	Data Sheet: MasterControl Change Control - Features Overview
	White Paper: Automating Document Control Processes to Comply with FDA and ISO Requirements
	White Paper: 21 CFR Part 11 - Are You Ready for an FDA Inspection?
	White Paper: 21 CFR Part 11- MasterControl Product Positioning

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