How it works

Manually processed batch-records often involving handwritten and other formats, is both laborious and error-prone, impacting compliance, quality, CMC and MSAT standards.

CPV-Auto™ is designed to address these challenges by simplifying and automating the entire process of data collection, processing, storage, and analysis.

The platform ensures the smooth transition of data from various formats, into organized and validated structured data, providing near real-time access to critical production parameters (CPP), complete audit trails and compliance, facilitating quicker and more informed decision-making.

Business Impact

Complete audit trail

Audit trail in compliance with 21 CFR Part 11, ensures electronic records are trustworthy, reliable, and legally compliant

Digital signatures & traceability

All changes to electronic records are authorized, documented, and attributable to specific individuals

Support for search & investigation Makes data more accessible and usable

Support for multilingual batch records Enhanced functionality and wider access for multi-location clients

Compliance and Standards

The rapid evolution of healthcare systems has led to the development of numerous medical products and procedures. To maintain the highest standards of quality and efficacy, regulatory bodies like the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have recently updated their guidelines on Process Validation for manual and non-standard processes. These updates emphasize the routine scrutiny of both products and processes.

CPV-Auto™ is specifically designed to meet these stringent compliance requirements. By adhering to various regulatory and quality standards, the platform ensures your operations remain aligned with the latest industry guidelines. Some of the key standards our platform complies with include