Antares Vision, the world’s leading provider of serialization-based track and trace solutions for the pharmaceutical industry, made the topic of validation & documentation a major focus at its May 18-19 User Group meeting in Brescia, Italy. Worldwide, Antares Vision has more installed serialization systems than all major competitors combined, and has stressed the importance of validation considerations as key compliance mandates loom ever closer.
Serialization requires equipment, process and computer system validation, and the timelines and approaches for each are different. Unfortunately, companies often underestimate the effort required to validate their serialization solutions and, as a result, run the risk of being caught at least somewhat unprepared.
Full-service vendors such as Antares Vision can help engage quality assurance and validation resources at the very start of projects to ensure their integration into overall work plans. Among other benefits, doing so saves both time and money by eliminating the need for re-validating components at a later date.
Antares Vision’s serialization solutions, which comprise both hardware and software, comprise a range of complementary services including pre-sales activities; installation assistance; training programs; quality, documentation and validation support; on-site and remote technical assistance; and preventive and planned maintenance service.
Antares is able to fully support its validation activities with detailed qualification documents designed in accordance with cGMP guidelines, relevant GAMP 5 standards, UNI EN ISO 9001 and FDA recommendations. Its quality assurance services, include:
• User Requirements Specifications (URS) reviews
• Quality plans
• Risk analyses
• Traceability matrixes
• Functional specification
• Design specifications for both hardware and software
• Protocols for Factory Acceptance Tests (FATs), Site Acceptance Tests (SATs), and Installation Qualification/Operational Qualification (IQ/OQ)
• Support for upgrading Standard Operating Procedures (SOPs)
• Validation summary reports
At the May 2016 User Group meeting, several experts stressed the scope of engineering resources needed to implement the complex validation practices that are increasingly mandated. To that end, adequate documentation includes serialization qualifications, operational qualifications and acceptance test protocols, among other needs.
“Validation and documentation – much like the greater topic of serialization and track & trace – are complex, investment-intensive efforts that, as discussed in our User Group, is best undertaken in partnership with true industry experts,” said Silvia Baresi – Head of the quality assurance dept. for Antares Vision.
Antares Vision has installed solutions on 750 production lines in 140 plants around the world, and more than five billion stock keeping units (SKUs) have been serialized, aggregated, shipped, and notified utilizing the company’s solutions.
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