סמארט לוג’יק מבצעת תיקי ולידציה למערכות ממוחשבות התואמות את התקנים 21CFRPart11 ו Annex 11 האירופאי.
לייעוץ בנושא ולידציה, התקשרו אלינו 08-910-2070.
בקטגוריה מידע כללי וטכני אודות ולידציה, מאמרים, הדרכות ועוד.
URS – Regulatory & HMI Requirements cover all the FDA specifications regarding the system compliance with the 21 CFR Part 11 definitions, and also with usual validation documentation demands HMI Requirementscover the provisions demanded from the HMI screens, regarding proper graphic design and functionality for controlling and monitoring the system, as specified in customer’s contract with the supplie
ולידציה – URS – מייצג את דרישות המשתמש, המאמר מפרט מה הן כוללות ומה יש לפרט עבור ביצוע הליך ולידציה
User Requirements Specification (URS) and Functional Requirements Specification (FRS) -Introduction
DQ – Design Qualification is for Design Review by verifying that the system has been designed as specified in the URS -User Requirements Specification, FDS – Functional Design Specification, and relevant equipment specifications satisfying all GMP requirements
Functional Requirements Specification -FRS Regarding Requirements for Compliance with 21 CFR Part 11
This article provide overviews of the main test procedures and verification, and their purposes. This OQ procedure is generic, and relevance of the test procedures and verifications provided below depends on the composition of the system under validation
The Operation Qualification (OQ) protocol is part of the validation documentation that covers the verification of the proper operation of the system under validation in the user’s facility. This OQ protocol is generic, and the system may include a PC with Human/Machine Interface (HMI), a Programmable Logic Controller* (PLC), pressure, temperature and humidity transmitters, and other monitoring and control components designed to maintain the user’s facility in proper environmental conditions (temperature, pressure and humidity)
ולידציה – Testing Process Automation Systems – Testing Responsibilities Supplier and User
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.
This article cover the third part of our Good Automated Manufacturing Practice (GAMP) test example. This part will cover the typical test phases for Factory Acceptance Test – FAT, Site Acceptance Test – SAT / Installation Qualification – IQ, Operation Qualification – OQand Performance Qualification – PQ
This article cover the second part of our Good Automated Manufacturing Practice (GAMP) test example. This part will cover the typical test phases for supplier’s application SW Module Testing, supplier’s Module Integration Testing and the supplier’s Integration Testing (cont’d) .
This article cover the first part of our Good Automated Manufacturing Practice (GAMP) test example.
