AlpVision Krypsos open platform to combat counterfeits has successfully achieved compliance with the software and quality requirements of the pharmaceutical industry and health authorities.

Krypsos is a server-based authentication system including the Cryptoglyph and Hybrid Cryptoglyph packaging covert security solutions as well as other security features such as for instance Fingerprint, the AlpVision detection solution based on intrinsic characteristics of the product. Third party overt coding such as Bar Codes, two dimensional matrix codes or OCR can also be included.

For a major deployment, which will bring covert protection to over a billion products worldwide by first quarter 2008, AlpVision Krypsos successfully passed the FDA 21 CFR Part 11 requirements for Electronic Records and Electronic Signatures (ERES).

The covert security feature is applied using only standard ink and standard printing processes (offset rotogravure, laser, inkjet, etc.). This technique is perfectly in line with the anti-counterfeiting requirements of the FDA Revitalization Act S.1082 for medicines delivered in the USA.

The Krypsos IT solution enables brand products manufacturers to provide their supply chain with a single point of contact for both drug counterfeit detection and genuine product authentication. It also provides valuable logistics data, such as gray market consolidation, and can generate helpful online notifications for mobile commerce.

Krypsos meets FDA 21 CFR Part 11 requirements providing the following functionalities:

Audit trail documentation

Electronic records

Advanced security controls and password protection

Event reporting and notification including: times, actions, users, and more

Central data storage in a single SQL database

Computer Systems Validation (CSV) was performed in compliance with the V Model and the corresponding documentation is available:

Validation Protocol

User Requirements Specifications

Functional Specifications

Design Specifications

Unit & Integration Tests

Installation Qualification

Operational Qualification

Performance Qualification

Validation Report

AlpVision has also a full QA system in place with following available documentation:

Document Management System

Development Standards

Incident, Problem & Change Management

Operational Handbook

AlpVision IT System Management

Backup/Restore, Archival, Retrieval

Network and Security Management

Configuration Management

Risk Analysis and Contingency plan

Please fill in the right hand side form or Contact AlpVision to evaluate how the Krypsos platform can be customized to your own IT and product environment, as well as your Corporate Visual Identity, to protect your branded products worldwide.