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 solution including the Cryptoglyph packaging and labeling invisible marking using regular visible ink and Fingerprint, the AlpVision authentication solution without additional marking used for various plastic molded vial and jar closures. Third party overt coding such as Bar Codes, two dimensional matrix codes or OCR can also be included.

Software delivered by AlpVision for protection of pharmaceutical products against counter-feiting and market diversion is FDA 21 CFR Part 11 compliant and is guaranteed to be in accordance with the GAMP 5 Computerized System Validation guidelines.

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.

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) is performed in accordance with the GAMP 5 guidelines:

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.