ולידציה – GAMP – Definition of Terms
30/09/2015
Good Automated Manufacturing Practice (GAMP) Definition of Terms Definition of Terms Used in Testing Environments This document provides a definition of a set of testing
Good Automated Manufacturing Practice (GAMP) Definition of Terms Definition of Terms Used in Testing Environments This document provides a definition of a set of testing
The third part of our Validation case study includes Documentation for IQ and OQ – to be checked at PDI/FAT, DQ Protocols Including PC/PLC, IQ Protocols Including PC/PLC, OQ Protocols Including PC/PLC, PQ Protocols Including PC/PLC
The second part of our case study deals with the Validation Requirements of Documentation for Initial Tender,Documentation for Design Review,Documentation Prior to FAT or Pre-Delivery Inspection – PDI& Commissioning
This is the first part of Validation Requirements – case study, it covers Document Contents & Responsibility
ולידציה – Function Design Specification- FDSPreparation Overview
ולידציה -FRS Contents This article was written by Iian Shaya, validation,automation and control expert The FRS presents functional requirements for installing and operating a monitoring
ולידציה – URS – מייצג את דרישות המשתמש, המאמר מפרט מה הן כוללות ומה יש לפרט עבור ביצוע הליך ולידציה
Functional Requirements Specification -FRS Regarding Requirements for Compliance with 21 CFR Part 11
ולידציה -Testing and HW/SW Type and Maturity – GAMPProcess automation systems generally comprise several elements. Categorizing these elements according to those described in GAMP 4 can assist in targeting testing and validation effort.
Installation Qualification (IQ) Protocol – Test Procedures. This article describes the test procedures for the installation of purchased software (SW) and application SW
ולידציה – GAMP – Hardware & Software Test Environments.HW can be categorized according to both GAMP 4 HW category (standard or custom) and its function within the test environment.. Test SW can also be categorized according to both GAMP 4 SW category and its function within the test environment
