Methodology

Overview

ACC employs a customer-centric approach to system life cycle documentation that is compliant with GAMP Version 4.0 and emphasizes design documentation, customer communications, and comprehensive system testing.

GAMP

GAMP stands for Good Automated Manufacturing Practice. The GAMP organization produces a guide for the validation of automated systems in Pharmaceutical Manufacture. This guide is the most widely used, internationally accepted, guideline for validation of computer systems.

Our Approach

All of ACC’s projects are implemented following our GAMP-based Project Methodology. This ensures that systems are developed with the necessary planning, life cycle documentation, and testing required for system validation. Our methodology consists of a set of Quality Management Procedures that describe both Project Specific Validation Activities, as well as General Validation Activities. The project specific activities of design, implementation, and testing follow a “Life-Cycle” development model on the core principal of “Define-Do-Test-Document”. The General Validation Procedures govern activities such as document control, scheduling, training and internal auditing.

Our project methodology follows a V-model that defines the documentation requirements, implementation standards and testing and verification requirements.

This methodology is supported by General Validation procedures that govern peripheral activities such as scheduling, training and internal auditing.

The Result

ACC follows a quality management system that defines methodologies and practices to be uniformly applied on all projects. This ensures the consistent application of a life-cycle development approach on all control system and software projects.