Purpose-built for the Life Sciences, Valgenesis digitizes your entire validation lifecycle, enabling validation teams to author, review, approve, test-execute, manage exceptions, and post-approve any business process in a 21 CFR Part 11 compliant web-based software – all securely accessible anywhere with an internet connection.
A Data Integrity assessment highlights whether all critical data is well-managed, easily retrievable, traceable, and archived throughout the entire data lifecycle.
Suggestions are given data protection from any type of modification, removal, or fraud. With an extensive experience in assessment, remediation, and implementation of data integrity, our experts make your data flow compliant with the existing standards and regulations.
Compliance Analysis & Gap Assessment
Business processes and procedures are scrutinized for compliance with guidelines such as data integrity, good manufacturing practices, good laboratory practices, good documentation practices, and good distribution practices. Preparation for specific audits (FDA, MHRA, WHO GMP etc.) can also be carried out.
The international legislation in GxP constantly changes. Thanks to advanced training programs our validation and compliance engineers have become experts in current FDA and EU regulations and directives. YSAT supports companies in the full preparation for audits and inspections by customers or by the government. Our unique combination of automation solutions and validation & qualification support makes us an ideal partner for the most challenging projects in Life Sciences industries.