The Journal of Validation Technology
Vol. 24, Issue 4, Aug 2018

Allan Marinelli
Paul L. Pluta
Consultant interactions is a topic that is rarely discussed in professional meetings, but is a topic of vital importance in the industry. Validation organizations in particular are often able to survive only by using a cadre of validation consultants.
Cliff Campbell
Discontinuities are a crucial but unaddressed issue within PV, and they are not the exception but the norm, and should be treated accordingly. Several examples are included in support of the premise that preventable manufacturing and quality problems....
Laurent Saugrin
This article introduces the process of selecting a suitable cloud provider. It also discusses the different procedures, or other supporting documentation, that must be in place to define responsibilities and commitments between the service provider and the client.
Ivan Soto
The FDA communicates the importance of quality metrics and their intent to implement a Quality Metrics program. Validation is a critical indicator of the quality of processes and system during their lifecycle.
Alan M Golden
In this paper, we will examine a simple method to design a sampling plan for process validations. Using a simple five step method, you can construct a statistically valid sampling plan for either attribute of variables data. Risk will be considered in a discussion of Acceptable Quality Limits (AQL) and Reject Quality Limits (RQL) and how they play...
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