FDA
Audit Process, Management software speeds up the audit process by providing the necessary information 483 Notice of Failed Audit, Management software helps provide the additional information needed if a company fails an Audit In the event of a failed Audit the FDA can force a company to stop production of a product, After compliance is achieved management software helps provide the information needed to restart production of a product The FDA can also force a company shut down all operations.
Management software helps provide the information needed to resume operations post shut down Product Recall
Management software helps insure CAPA (Corrective Action Preventative Action), and issue review processes are followed, from initial loss to sign off and completion post production lawsuit, Management software helps support the legal department to show that management was not negligent in the production of a product.
ISO
Management software speeds up the audit process by providing the necessary documentation and information Failed audit Management software helps provide the additional information and prepare the forms needed if a company fails an Audit force them to stop a product, after compliance is achieved management software helps provide the information needed to restart production Force company shut down Management software helps provide the information needed to resume operations post shut down recall, Management software helps insure CAPA (Corrective Action Preventative Action), and issue review processes are followed, from initial loss to sign off and completion post production lawsuit, Management software helps support the legal department to show that management was not negligent in the production of a product.
An enterprise wide quality management system to establish IT governance helps a company in a number of ways. Management software, manages documents, work flow, makes sure policies and standards are followed, improves efficiency, uses less manpower, speeds up the training and retraining processes it also helps with continuous validation as well by minimizing turnaround time. An effective system the built in continuous validations compliance do not take months to implement. The right system may also help control costs in other sectors, such as legal costs, customer satisfaction and insurance as well.
References
Master Control. (2010). Six Ways to Optimize Your Quality Management System and Ensure FDA and ISO Compliance. Master Control.
Master Control, Inc. (n.d.). ISO Compliance. Retrieved 4 2, 2012, from Master Control, Inc.: http://www.mastercontrol.com/resource/online_resources.html#od
Master Control, Inc. (n.d.). Master Control FDA Compliance Video. Retrieved 4 2, 2012, from Master Control, Inc: http://www.mastercontrol.com/three_min_demo.html
Master Control, Inc. . (n.d.). Master Control Resource Center. Retrieved 4 2, 2012, from Master Control, Inc. : http://www.mastercontrol.com/resource/online_resources.html#od
United State's Department of Health & Human Services. (n.d.). Inspections, Compliance, Enforcement, and Criminal Investigations. Retrieved 4 2, 2012, from United State's Department of Health & Human Services: http://www.fda.gov/ICECI/ComplianceManuals/default.htm
United States Environmental Protection Agency. (n.d.). Environmental-Management-System-ISO-14001-Frequently-Asked-Questions. Retrieved 4 2, 2012, from United States Environmental Protection Agency: http://water.epa.gov/polwaste/wastewater/Environmental-Management-System-ISO-14001-Frequently-Asked-Questions.cfm
