Easy-GxP is a fully validated Software Suite for Life Sciences, IT and AI, designed from ground up by a team of experts with deep industry knowledge.
The system was built with flexibility in mind, which allows to easily create unique process flows derived from any industry regulation or guidance, by simple drag and drop functions, without the need of custom coding.
And since it satisfies the rigor of FDA and EMA, its applicability can be easily extended to other fields where different rules and standards apply (e.g. NIST Cybersecurity frameworks, GDPR, etc.)
Our built-in fully compliant 21 CFR Part 11 electronic signature feature, comes all inclusive with unlimited envelopes, no hidden cost. No need to keep track of how many e-signatures you have left before paying an obscene amount of money just to sign things (or even worst, combining unrelated documents in one package, to save envelopes)…
Electronic Execution / e-Signature Module
The Electronic Execution / e-Signature module is the easiest path to fully compliant 21 CFR Part 11 GxP forms, Test Cases execution, or any other documents where Data Integrity, or ALCOA+ principals are required.
Send for self or collective fill & sign
When importing deliverables, the system allows flexible in series or parallel execution by multiple users with pre-approvals / post approvals, or any combination thereof.
Fill and Sign editor with full audit trail.
The built in Part 11 compliant execution tools, audit trail and other useful features like embedded evidence gathering, makes GxP execution a breeze without the need for printers, paper, ink and waisted time.
Flexible routing
The system’s dynamic approval and execution routing allows maximum flexibility while maintaining control (e.g., replacing a reviewer that’s in vacation it’s easy, but requires formal justification and e-approval)
Export to your favorite system.
Easy-GxP plays well with others and lets you export with ease, securely executed flows (including embedded attachments, appendixes, full audit trail) as one pdf to your current QMS / documentation system.
