Siegfried Schmitt, principal consultant, PAREXEL, discusses how to assure compliance for automated systems. Siegfried Schmitt, principal consultant, PAREXEL, discusses how to assure compliance for ...

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 ...

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 ...

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 ...

株式会社日立システムズ、キヤノンITソリューションズ株式会社（キヤノンITS）、株式会社EPクロア、株式会社JSOL、ビジネスエンジニアリング株式会社（B-EN-G）、フィラーシステムズ株式会社の6社は17日、製薬・医療機器メーカーに向けて、Amazon Web Services ...

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.

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 ...

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 ...