Antares Vision
YOUR INSPECTION AND
TRACEABILITY PARTNER
Quality and Validation
Quality and Validation Activities
Pharmaceutical Manufacturers quality assurance system has qualification and validation in their values as well as in they requirements.
Antares Vision is fully able to support quality and validation processes with detailed qualification documents designed in accordance with the cGMP guidelines, the relevant GAMP 5 standards, UNI EN ISO 9001 and recommendations by the FDA.
 
 
  •  Antares Vision 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
 
 
  •  Antares Vision can satisfy the documentary requests of 21CFR part 11 directive of the FDA
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 can satisfy the documentary requests of GMP - ANNEX 11
In the European Union, great importance is attached to Directives 2001/83/EG and 91/356/EG. The latter describes the EU GMP regulations that are binding for the Member States, and that are interpreted in the EU GMP guidelines and its appendices. The core statement of Annex 11 with regard to computer validation is that if computer-assisted systems initially perform manual activities, neither product quality nor quality assurance should be diminished.
 
 
 
  • Antares Vision is ISO 9001 certified
Antares Vision provides a complete service for an efficient execution of the validation process, with the purpose to achieve the following objectives, in addition to fulfill the normative requirement:- increasing process knowledge through improved knowledge of the system, increasing familiarity with the computer/ assisted inspection system,
minimizing the risk of malfunction, lowering the cost of operating the system, lowering the cost of expanding the system
 
 
 
 
  • Antares Vision is Integration with SAP applications certified
The Antares Tracking System software has proven to interoperate with one or more SAP applications using integration technologies such as a BAPI® programming interface, remote function call (RFC), or intermediate document (IDoc) technology.
 
 
 
  • Antares Vision products and solutions comply with GAMP 5