The following paragraphs contain experts from the GAMP 5 Appendices, and summarizes their content. For further concise information please reference the GAMP 5 guidelines. 2.1 Backup & Restore -appendix O9 The backup and restore should be a well define company procedure.
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GAMP 5 - Good Automated Manufacturing Practice MasterControl GAMP 5 Offers Good Automated Manufacturing Practice Guidelines for Manufacturing Companies to Comply with Regulated Environments MasterControl's Quality Management Systems are designed by industry practitioner for automating the GAMP 5 process in any organization. A Quality Management Software 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 GAMP 5 system reduces audit time and findings, and a decreases risk of product recalls. It improves product quality and safety, increases customer satisfaction, and ensures FDA and ISO compliance. How the White Paper about GAMP 5 can help You The International Society for Pharmaceutical Engineering (ISPE) issued the worldwide release of GAMP 5: A Risk-Based Approach to Compliant GxP Computerized Systems in March of 2008. The updated manual for GAMP 5 provides guidelines for good automated manufacturing practices that are referenced in markets around the world, including North and South America, Europe, and Japan. The white paper that you can download above offers GAMP 5 guidelines and offers ideas on how companies can utilize the processes and templates in the updated manual for GAMP 5 to minimize validation efforts and improve by good automated manufacturing practices.