Optimize your change control process — Ensure FDA and ISO compliance

January 18, 2006 — /MasterControl/ — In business, just like in life, there is nothing more constant than change. The fact that change is inevitable makes “control” critical, especially in FDA and ISO-environments, where inappropriate or “uncontrolled” changes could affect the safety and reliability of products and directly impact public health and safety.

Is your change control system on a par with FDA and ISO requirements? Download this white paper and find out how you can optimize your change control process to facilitate continuous quality improvement and ensure sustained compliance.

White Paper Download:

Titled “Change Control – Quality Improvement in FDA & ISO Environments,” the white paper discusses what FDA inspectors and ISO auditors consider one of the most critical regulatory principles. The white paper includes:

–Definition of change control in the context of FDA and ISO environments.
–Specific FDA requirements and ISO standards pertaining to change control.
–Elements of a typical change control process.
–Common problems pertaining to change control – and solutions for optimizing the process.

About MasterControl
This white paper was prepared by MasterControl Inc., a leading software provider for regulated companies. More than 400 companies worldwide use the MasterControl˙ integrated quality management suite to consistently meet FDA requirements and industry quality standards, such as ISO and QS/TS.

The MasterControl suite is a configurable, off-the-shelf, and easy-to-use solution for automating and effectively managing documents-based and forms-based quality processes, change control, training control, corrective/preventive action (CAPA), audits, and customer complaints processes for sustained compliance. MasterControl also offers comprehensive technical and customer support, including product training, installation, implementation, and validation services. For more information, visit http://www.mastercontrol.com or call 800-825-9117.


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