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Category: Gestão da Qualidade

MERRY CHRISTMAS from M A N O S T A X X – Industrial Management Consulting
Benchmarking

MERRY CHRISTMAS from M A N O S T A X X – Industrial Management Consulting

Posted on December 25, 2022 by admin

Merry Christmas, This is a time of family and Happiness. This a time to review the year 2022 Manostaxx team feels blessed to have had…

Managing Efficiency in a Quality Organization
Chemical

Managing Efficiency in a Quality Organization

Posted on June 13, 2018 by admin

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,…

Oops, My mistake!!
Gestão da Qualidade

Oops, My mistake!!

Posted on May 27, 2018 by admin

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…

VALIDATION SUMMARY REPORT FOR THE EXAMPLE VALIDATION SPREADSHEET – PDF Download
Download

VALIDATION SUMMARY REPORT FOR THE EXAMPLE VALIDATION SPREADSHEET – PDF Download

Posted on May 14, 2018 by admin

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…

A Case Study of ERP System Validation
Download

A Case Study of ERP System Validation

Posted on May 13, 2018May 13, 2018 by admin

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…

General Principles of Software Validation; Final Guidance for Industry and FDA Staff – PDF Download
Download

General Principles of Software Validation; Final Guidance for Industry and FDA Staff – PDF Download

Posted on May 13, 2018 by admin

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…

Statistical Solutions: Square Root of (N) + 1 Sampling Plan
Chemical

Statistical Solutions: Square Root of (N) + 1 Sampling Plan

Posted on May 9, 2018 by admin

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…

Sampling Plan for Pharmaceuticals
Gestão da Qualidade

Sampling Plan for Pharmaceuticals

Posted on May 9, 2018 by admin

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…

Sample, Skip and Switch – The Basics of Risk-based Incoming Inspection
Chemical

Sample, Skip and Switch – The Basics of Risk-based Incoming Inspection

Posted on May 8, 2018 by admin

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…

ANATOMY OF THE ANSI ASQ Z1.4 INDUSTRY-STANDARD AQL TABLE
Gestão da Qualidade

ANATOMY OF THE ANSI ASQ Z1.4 INDUSTRY-STANDARD AQL TABLE

Posted on May 7, 2018 by admin

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…

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