In-house experts can help select the right systems and suppliers, making validation and compliance easy, says Siegfried Schmitt, principal consultant at PAREXEL. Q. We are planning to upgrade several ...

Computer system validation, popularly known as CSV is the process of procuring documented evidence that ensures the consistent performance of a computerised system as required by the operational ...

Computerized systems are those which comprise the components shown in Figure 1.1, namely, a computer system and a controlled function which is operating within its specified working environment. The ...

OSAKA, Japan, Dec. 4, 2025 /PRNewswire/ -- HiroPharmaConsulting (R) Co., Ltd. announced that it has received a patent for an innovative Good Pharmacovigilance Practice (GVP) Computerized System ...

～調査業務のあらゆるニーズに対応しMR活動のDXを推進～ DigiPro® EPPVは市販直後調査に必要な機能を取り揃えており、製薬企業様の多様なニーズに対応する柔軟なサービスです。また医薬品の安全性情報管理の信頼性確保のために必要なCSV（Computerized System ...

Dublin, June 25, 2025 (GLOBE NEWSWIRE) -- The "Computerized Systems Validation, Data Integrity & Cloud Computing In Pharma & Biotech" has been added to ResearchAndMarkets.com's offering. The seminar ...

Dublin, Nov. 07, 2025 (GLOBE NEWSWIRE) -- The "Computerized Systems Validation, Data Integrity & Cloud Computing In Pharma & Biotech (Dec 9th - Dec 10th, 2025)" training has been added to ...

Computer System Validation is a regulatory requirement under ICH GCP and 21 CFR Part 11 but it also makes good business sense to ensure that computerized systems will perform consistently as expected.

Title 21 CFR Part 58 provides guidance on Good Laboratory Practice (GLP) for executing non-clinical laboratory studies that support applications for research permits for Food and Drug Administration ...