http://www.manostaxx.com In today’s business environment, a quality organization that focuses strictly on compliance while ignoring inefficiency will not succeed. Operational challenges such as cost reduction,…
Category: Gestão da Qualidade
http://www.manostaxx.com We had our recertification audit for ISO9001:2008 last week, and for the first time since 2004 have been found wanting. Darn. For the first…
http://www.manostaxx.com This Final Summary Reports summarizes the results obtained during the execution of the Installation/Operational (IOQ) Qualification (IOQ-001), for the validation of the Example Validation…
http://www.manostaxx.com Used to control and manage business processes, enterprise resource planning (ERP) software can be upgraded to ensure compliance with electronic records and signatures (ERES) regulations and guidances as well as other…
http://www.manostaxx.com This guidance outlines general validation principles that the Food and Drug Administration (FDA) considers to be applicable to the validation of medical device software…
http://www.manostaxx.com Originating in the 1920s as a sampling scheme for agricultural regulatory inspectors, the square root (Sqrt) of the lot size (N) + 1 was…
http://www.manostaxx.com Q: We are a U.S. dietary supplements manufacturer operating under c-GMP conditions set by the U.S. Food & Drug Administration (FDA). As such, we perform analyses…
http://www.manostaxx.com You’re probably conducting incoming inspections today but if you aren’t taking a risk-based approach, chances are you’re performing inspections you don’t need to do…
http://www.manostaxx.com Many importers don’t bother to learn about AQL sampling for product inspection because they think the AQL table is too technical. The numbers, letters…
http://www.manostaxx.com Military Standards Can be downloaded free of charge using the website: http://assist.daps.dla.mil/quicksearch/. MIL-STD-1916 (1996) – DOD Preferred Methods for Acceptance of Product To download…