Validated Document Control (VDC) Demo
A live, serverless AWS implementation of a GxP-capable Validated Document Control system, including full FDA-ready documentation (URS, FS, RTM, IQ/OQ/PQ) and a production-grade identity and audit architecture.
Built entirely on Amazon Cognito, Amazon API Gateway, AWS Lambda, Amazon DynamoDB, Amazon S3 (with Object Lock for WORM audit storage), AWS IAM, AWS CloudFormation, Amazon CloudFront, and Amazon CloudWatch.
Purpose: In regulated Life Sciences environments, teams must be able to demonstrate who performed an action, when it occurred, under which role, and what controls enforced it. This VDC system shows how to implement those requirements on AWS using native, serverless services.
What this demo proves: On-premise GxP document control is no longer the only option. A modern AWS serverless stack can deliver the same GxP-grade controls (workflow, identity, audit trail, data integrity, ALCOA+, 21 CFR Part 11 patterns) at a fraction of the cost and operational overhead of traditional infrastructure.
Run the end-to-end workflow
Sign in with a Submitter account to upload and submit a document, then sign in as an Approver to review, approve or reject, and inspect the immutable audit trail.