ValGenesis selects Smarttech Consulting Services (SmarttechCS) as european distributor for enterprise validation management and tracking system
Smarttech Consulting Services (SmarttechCS), a provider of technology for enabling regulatory compliance, has entered into an agreement with ValGenesis.
SmarttechCS will provide direct sales support for marketing, implementation, and integration of ValGenesis, an Enterprise Validation Management and Tracking System designed to manage the entire validation life cycle from validation document number generation to online execution while meeting compliance requirements imposed by the EU regulators.
ValGenesis was designed to fill the void in the life science industries for a validated inventory tracking system with a built-in e-signature capability.
ValGenesis is the first product in the industry capable of conducting validation test script execution electronically equating to a completely paperless validation process.
ValGenesis is a modular, web based database application that is fully compliant with 21 CFR Part 11 and EU Directive Annex 11.
Each module in ValGenesis serves a specific function such as tracking the validation status of any GxP entity, developing validation documents in a collaborative manner, executing validation documents online, and scheduling revalidation tasks.
"With ValGenesis, companies can easily deploy a validation system working within their quality management.
"As standardisation using corporate intranet/web enabled solutions increases, more companies are looking for assistance to implement controls enabling better Collection, Collation, Collaboration and Compliance" said Adrian Carter, director for SmarttechCS.
"We were chosen by ValGenesis because of our experience within the Pharmaceutical industry with solutions that enable regulatory compliance".
The need for a company such as SmarttechCS to act as European distributor grew out of the increase in European demand for validated applications where ValGenesis can maintain a consistent validation methodology across all departments and company sites - something the regulators recommend ValGenesis will improve the overall efficiency of the validation process resulting in dramatic time and cost savings.
