PharmTech

Computerized Systems Validation

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

Computerized Systems Validation

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 ...
Royal Society of Chemistry

2-day In-person Seminar on Validation and Part 11/Annex11 Compliance of Computerized Analytical Systems and Data at Singapore

Analytical equipment should be qualified and computer systems should be validated to demonstrate suitability for the intended use. Electronic records must comply with FDA Part 11 and EU/PICS GMP Annex ...
AZOM

Analytical Method Validation in Thermal Analysis

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 ...