CPV-Auto™ 's benefits include process conformance and compliance for faster time to PPQ, improved data integrity and audit readiness while reducing costs and expediting batch releases. Accelerated data curation, enhanced availability and consolidation delivers increased efficiency. The complete audit trail, digital signatures, and traceability, ensures transparency, accountability, and regulatory compliance.

Additionally, the multilingual batch records support and robust search and investigation capabilities, empower clients to efficiently manage and use their data.

The platform can be used to process documents that have pre-clinical, clinical, internal and external (CDMO) manufacturing data, including hand written text .

CPV-Auto™ is 21-CFR Part 11 compliant and meets all the defined GxP norms. This cloud-based, validated solution, enables the best-in-class security protocols.

No. The CPV-Auto™ platform does not train the AI engine using client data. All data is treated with utmost confidentiality and is securely handled.

Documents in a variety of languages can be processed using CPV-Auto™. Outside of English, some languages that are supported include German, French, Dutch, Italian, Spanish, Portuguese, and Swedish.

The batch records are fetched through a shared location such as a Box or SharePoint folder and the final structured data is pushed back into the same. For large data sets, an API access layer is provided. There is additionally, an interface for tracking and monitoring task status, viewing audit logs, and investigations, analyzing reports, and previewing the generated output files.

CPV-Auto™ offers a 5x increase in productivity. A proof of value done at the start of an engagement determines the customized TAT for each client.

CPV-Auto™ maintains data privacy and security standards as per the 21 CFR Part 11 compliance, hence, all data at rest is encrypted. Access is restricted through the system and all data is hosted within US shores.

All data resides in a dedicated single tenancy platform on the cloud, offering a high degree of security and confidentiality. While there is a strict data retention policy of 30 days, the period is customizable based on the client's requirements and specifications. After the designated retention period, all data (batch records and output data) is deleted and the data deletion report is shared with the client.

The CPV-Auto™ platform is flexible and can typically accommodate or address most client requirements.

Yes. While CPV-Auto™ is a proven concept, being deployed by multiple global biopharma organizations, what is recommended is conducting a Proof-of-Value (POV) to understand the value the client organization would realize from an implementation.

Normally no, since CPV-Auto™ is a Data-as-a-Service platform, and all records are fetched and sent back within that cloud-based instance. However, in case of larger data sets, an API integration is sometimes necessary, which is then done in collaboration with the Client’s IT team.

No organization is too small to benefit from the digitization process. However, Clients with at least one drug in the clinic typically see significant benefits from using CPV-Auto™.