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.
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.
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.
Learn the key general technical writing principles and then apply them to your validation documents. High level objectives for validation documents are discussed.
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.
Join this forum for validation professionals to discuss their actual work experiences – problems and solutions to problems that may be helpful to other validation professionals