The Journal of Validation Technology
Vol. 24, Issue 6, Dec 2018

A review of this past year and a look at what's to come. Thank you for being a part of a remarkable year.
Eliane Veiga
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Nuala Calnan
When considering GxP applications, a robust approach to risk-based computerized system lifecycle management requires well-defined processes, use of a qualified infrastructure, validated design and deployment of software, qualified personnel, rigorous change management and version control.
Ivan Soto
Requalification is a critical regulatory function in the pharmaceutical and biotech industry. The intent of a requalification program is to periodically requalify GMP systems to ensure that they remain in a validated state.
Valarie King-Bailey
Privacy and data protection are more important than ever. Today’s headlines are filled with instances of data privacy breaches as well as cyber security breaches among leading global firms.
Paul L. Pluta
Learn the key general technical writing principles and then apply them to your validation documents. High level objectives for validation documents are discussed.
Yeong-Lin Chen
This article presents three tiers of medical device process validation plans structure (including Site Validation Master Plan (SVMP) - Tier I, Validation Master Plan (VMP) - Tier II, and Individual Validation Plan (VP) - Tier III), explains the rationale of the plan structure, and provides the key content for each validation plan.
Paul L. Pluta
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