Serialization Compliance Qualification & Validation

Antares Vision supports your qualification and validation efforts with qualification documentation, as well as advice and consultation regarding the execution of tests.

Detailed qualification documentation that conforms to current standards and GAMP 5 regulations is available.

Antares Vision is able to fully support quality and validation processes with detailed qualification documents designed in accordance with cGMP guidelines, relevant GAMP 5 standards, UNI EN ISO 9001 and FDA recommendations.

Quality Assurance Activities

User Requirements Specifications Review

Quality Plan

Risk Analysis

Traceability Matrix

Functional Specification

Software Design Specification

Hardware Design Specification

FAT Protocol

SAT Protocol

IQ/OQ Protocol

Support to Customer SOPs upgrade

Validation Report

Satisfaction of documentary requests per FDA 21 CFR part 11 directive

In the United States, the general regulations for drugs, food and cosmetics, are set down in CFR 21, Food and Drugs, and relate to the expanded Federal Food and Cosmetic Act. 21 CFR 210/211 describes the “current Good Manufacturing Practice” (cGMP) for human drugs and, as a quality-control measure, explicitly calls for validation activities for automatic, mechanical and electronic equipment – for example, computer systems – which should be inspected and checked according to a written program designed to assure flawless operation.

Antares Vision is ISO 9001 Certified

Antares Vision provides complete service for the efficient execution of the validation process, with the purpose of achieving the following objectives, in addition to fulfilling the normative requirement:

Increasing process knowledge, increasing familiarity with the computer/assisted inspection system, minimizing risk of malfunction, lowering the system’s operating cost, and lowering the cost of expanding the system

Certified for Integration with SAP Applications

The Antares Vision Tracking System software has proven compatibility with one or more SAP applications using integration technologies such as a BAPI® programming interface, remote function call (RFC), or intermediate document (IDoc) technology.

GAMP 5

Antares Vision products and solutions comply with GAMP 5