The smart way to digitize Pharma & Biopharma batch records

The cloud-based Data-as-a-Service platform that automates the process of data collection, processing, storage, and analysis, offering near real-time access to Critical Production Parameters (CPP) from internal and external sources for quicker decision making.

digitization of Pharma & Biopharma batch records

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 multilingual batch records

Enhanced functionality and wider access for multi-location clients

Support for Search & investigation

Facilitates easier access to the data for analysis and investigation

Additional Benefits

Quicker time to market

Improved mandatory data and audit readiness

Process conformance - improved time to PPQ, IND, BLA, NDA filings

Reduced costs & faster batch releases ensures faster QC of batch releases

Faster QC and batch releases

Data availability and consolidation for MSAT

50-70%

reduction in the total cost of ownership

GxP

compliant

100%

data accuracy

300%

reduced batch record processing time

How it works?

CPV-Auto™ simplifies and automates the digitization of paper batch records in a highly secure, GxP compliant, cloud-based Data-as-a-Service platform.

It converts unstructured data into structured data formats, that offer easy access to the data. A workflow, inclusive of quality checks ensures the authenticity and accuracy of the data.

Client Testimonials

  • "With CPV-Auto™, our turnaround from raw data to structured data has been greatly improved (efficiency)."

    A Global Biotechnology Firm

  • "For mature processes, CPV-Auto™ support allows us to rapidly turn around data for analysis, investigations, etc. for our internal customers"

    A Creative Gene Therapies Company

  • "CPV-Auto™ has helped us increase the use of data analytical capabilities to support new chemistry discovery processes."

    A Pharma and Therapeutics Company

  • "Using this platform, we have digitized historical batch records, making data easily accessible and fully utilized for analysis which saves us significant time and effort, with a turnaround almost half of what it would have been internally, and reduced the need for additional hiring."

    A Leading Biotechnology Company

  • "The quick turnaround, prompt discrepancy communication, and reliable data accuracy have streamlined our processes. Additionally, timely adjustments to the process ensures the integrity and reliability of our data. This service has been a game-changer for us."

    A Global Biopharmaceutical Company

  • "We have greatly benefited from Aventior’s service, particularly in eliminating the manual data entry process. Our time and efforts are significantly reduced as we can directly load transcribed, reviewed data into our process information management system."

    A Global Biopharmaceutical Company

  • "The platform's comprehensive audit trail ensures traceability and accountability. They also have a clear documentation & resolution process for contradictory responses."

    A Leading Biotechnology Firm

Resources

Challenges of Continued Verification Process in the Pharma Industry

Unstructured Data Solutions: the key to Unlocking Business Insights

Data Visualization: Investigative Analysis and Insights

FAQs

  • 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, and enhanced availability delivers increased efficiencies and a shorter time to market. 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 your data. Your data is treated with utmost confidentiality and is securely handled.

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