AutomataNow delivers daily, auditable Automated Computer Systems Assurance (ACSA) reports that keep GxP-regulated systems continuously validated. By automating compliance monitoring, the service ensures that computer systems remain in a validated state, reducing manual effort and supporting regulatory audits.
Funding
Funding not disclosed
Founders
Product
Problem
GxP‑regulated organizations must keep computer systems continuously validated, but traditional compliance relies on periodic manual audits and extensive documentation, leading to high labor costs and risk of undocumented changes.
Solution
AutomataNow delivers daily, auditable Automated Computer Systems Assurance (ACSA) reports that automatically capture the state of GxP systems and any configuration changes. The platform continuously records system parameters, generates verifiable assurance documentation, and updates compliance status in real time. By eliminating manual audit preparation, it reduces operational overhead while providing regulators with a transparent, immutable audit trail of system validation.
Target Audience
Primary customers are pharmaceutical, biotech, and medical device companies that operate GxP‑regulated computer systems and need continuous validation to satisfy regulatory requirements.
Features
- Automated daily collection of system configuration and operational data for GxP environments
- Real‑time generation of auditable ACSA reports with cryptographic timestamps
- Immediate detection and documentation of any system changes affecting validation status
- Centralized dashboard for continuous compliance monitoring and historical audit retrieval
- Integration hooks for common GxP software stacks to ensure seamless data ingestion