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Automate Document Reviews & Quality Checks in Pharma

Instantly capture and check key information from scanned Batch Records, Production Orders or CoAs: 

  • automate standard checks

  • save 60-80% time and accelerate detection of issues

  • turn scanned paper into structured, searchable data

Made for Quality, Compliance & Regulatory Teams in Life Science & Pharma

Whether you drive quality initiatives, navigate regulatory requirements or
optimise operations, our models adapt to your priorities. We work with Big
Pharma, Virtual Pharma, CDMOs, Biotech and Medical Device companies.

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2026 Report: AI for Quality and Regulatory in Pharma

How industry leaders in pharma use AI across Quality and Regulatory processes, and where the efficiency actually comes from.

Automated Document Review Is a Fast, Lower-Cost Step Towards EBR

Automating the review digitises the rules behind your Master Batch Record: the foundation paper-on-glass and full EBR build on later.

Time to first product line

~3 months

from assessment to live product, instead of the 18 to 36 months an EBR rollout typically takes.

Cost model

70k - 200k licence

instead of the 2M+ USD for a full EBR programme implementation in a mid-size Pharma company

Shop floor impact

None

it sits on the review side: no process redesign, retraining or new validation.

And it grows into EBR in three levels:

Years of Work to Build Functionalities You Can Rely On

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Manual document extraction & review takes hours and is error-prone.
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Reliable AI-powered automation with configurable Experts-in-the-loop reviews.
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Generic LLMs cannot handle lengthy and complex PDFs.
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Best solution for documents with 1000s of pages, messy layouts, tables, handwriting and graphics.
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One-size-fits-all and black-box AI.
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Transparent and versionable AI models, fine-tuned and contextualized for you.
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Regulatory compliance and auditability.
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Every step is logged with a full audit trail for inspections. Your data, your AI models.

Cut Document Review Time by 60-80%, Without Compromising GxP

Acodis is not a generic OCR tool and not a standard LLM. Every model is trained for the documents your teams actually work with, and GxP compliance is part of the architecture. That is why these results hold up in regulated environments:

  • Deterministic models
  • Enhanced accuracy and data integrity
  • GxP compliance by design

16,000 h

spent on batch record review per year, manufacturing and QA combined

~€1.66M

modelled annual savings from automating the standard checks

25%

shorter batch release cycles by catching errors earlier

8.3x

modelled return on investment per year

Illustrative model for a mid-size CDMO processing 2,000 batches a year at roughly 140 pages per record, based on aggregated data from Acodis customer implementations. Actual results vary. We build the same calculation with your numbers as part of the assessment.

FULL ROI BREAKDOWN

Rated by the Best

Global leaders in the pharmaceutical, manufacturing, and chemical industries trust Acodis. Source: Reviews on G2.com
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Use Cases of Pharma & Health Clients

Talk to our experts about automating document reviews & quality checks in Pharma and Life Sciences

  • See Acodis live for your industry
  • Get an honest fit assessment for your use case
  • Leave with clear next steps and timelines

Tell us about your use case and we will get back to you.

Contact Us

Frequently Asked Questions

What types of documents and formats can Acodis handle, including handwritten or scanned files?

Acodis can handle a broad range of document types, including PDFs, Word files, Excel sheets, PowerPoint decks, scanned documents, images, & even handwritten text. Whether your documents are structured, semi-structured, or entirely unstructured, Acodis extracts the relevant data accurately. Even from complex formats like tables, multi-page reports, or low-quality scans.

Does Acodis support multilingual documents?

Yes, Acodis is language-agnostic and supports the processing of multilingual documents written in left-to-right (LTR) languages. The platform extracts data accurately across a wide range of European, Asian, and global languages. At this time, right-to-left (RTL) languages such as Arabic, Hebrew, Persian, and Urdu are not supported, but they are on our roadmap for future development.

How accurate and reliable is the extraction across handwriting, scan artefacts, and varied layouts?

Acodis achieves 96-99%+ extraction accuracy (measured in F1 score), even on handwritten fields, scanned documents and inconsistent layouts, by using multiple specialised AI models per document element rather than one generic OCR engine. With confidence scores and a fast interface for human reviews, our users bring the final accuracy to 100%.


Instead of a single model attempting every field type, Acodis fine-tunes separate models for tables, signatures, handwriting, and free text on each client's real documents. This targeted approach is what allows reliable performance on the messy, real-world documents common in pharma and life sciences - tilted scans, handwritten annotations, and non-standardised layouts. We routinely achieve 96–99%+ F1 scores within 20–50 training documents, depending on layout complexity.

Does Acodis model flag low-confidence values instead of guessing?

Yes, Acodis never auto-accepts uncertain data. Two safeguards route low-confidence or non-conforming values to human reviewers: automatic confidence scoring and configurable data validation rules.

Any extracted value falling below a set confidence threshold is automatically flagged for review rather than accepted silently. In parallel, configurable validation rules check format, range, and content conformity, flagging anything that fails business logic even if the model itself was "confident." This dual-layer approach is central to safe AI deployment in regulated environments: it keeps human experts in the loop exactly where judgment is needed, while automating the rest. 

Does the system auto-detect document structure and fields or do we have to manually map and tag every field?

Acodis models auto-detect document structure and fields from training examples - manual field-by-field mapping is not required for every document. Auto-labelling and LLM-assisted tagging accelerate setup, with a first working model typically ready after just 20 documents.

Does Acodis support GxP compliance and validation requirements?

Yes. Acodis is built to support GxP-regulated environments and aligns with GMP-compliant documentation requirements. The platform ensures traceability, complete audit trails, version control, and robust data integrity — all critical for regulated processes.

Can Acodis integrate with our current systems (like LIMS, QMS, ERP)?

Yes. Acodis integrates seamlessly with existing enterprise systems such as LIMS, QMS, ERP, and other document or data platforms. This includes a standard integration into Veeva.
As a SaaS solution, we supports flexible integration options including REST APIs, FTP, and other standard protocols, whether you're working in a cloud, hybrid, or on-premise environment.

How does Acodis sustain model accuracy and governance over time?

Acodis models typically achieve over 96% accuracy, depending on the quality and consistency of input data. To maintain and improve this over time, we use a human-in-the-loop approach - allowing users to review, validate, or correct extracted results when needed.
These inputs are continuously fed back into the model, enabling ongoing learning and optimization. Combined with full audit trails, version control, and change tracking, Acodis ensures both high performance and strong governance throughout the document processing lifecycle.

How does Acodis handle evolving document templates or changing formats?

Acodis is designed to empower domain experts with an intuitive, self-service platform that makes it easy to adapt document models to new templates, formats, or changing requirements — without needing support from the Acodis team.
This flexibility allows your internal teams to stay agile and maintain automation workflows as processes or regulations evolve.

Can this be hosted in our own cloud environment and do you meet standard security certifications?

Acodis is deployed in SaaS mode, either through our own Azure hosting or as a managed application in the Azure environment of the clients. We provide dedicated instances to each client. Your models, your data.

We maintain high security standard with ISO 14001, 9001, 27001 and Soc 2 certifications.

How do you ensure data security and privacy?

Acodis ensures data security and privacy by adhering to strict Swiss data protection laws. All data is hosted in Switzerland, encrypted both in transit and at rest, and never shared or reused across clients. You retain full data ownership, and we guarantee data deletion upon request, in line with your internal policies and regulatory requirements.

What is Acodis' approach to AI?

Acodis converts unstructured documents into structured, AI-ready data — enabling intelligent automation, precise data extraction, and smooth integration into your AI and analytics workflows. This foundation powers natural language processing (NLP), machine learning (ML), predictive models, and generative AI initiatives.

Whether you're automating document-heavy processes, improving AI-driven decisions, or training large language models (LLMs), Acodis ensures your internal data is accurate, accessible, and compliant. Ready for business intelligence, data science, and practical AI deployment.