How long does it take to implement batch record automation?

Acodis can be up and running on your first product in as little as 4–5 weeks. The process starts with a 3-week feasibility and scoping phase using your existing documents, followed by a 1-month implementation. Unlike full EBR systems which can take 12–24 months, smart automation works on your current paper or PDF batch records without requiring process transformation.

How to accelerate Batch Record reviews in Pharma?

Q: How can an automated system provide GxP compliance in relation to Batch Records?

Smart automation acts as an assistant that prepares the review for Quality experts. It automatically checks for signatures, batch numbers, and certain values, while handwritten annotations are still reviewed by humans. The goal is not to remove human oversight, but to enable Quality experts to review batch documents in 2 hours instead of 5. Acodis systems are built with GxP, GAMP 5, 21 CFR Part 11 and European Annex 11 in mind.

Q: What types of documents and formats can Acodis handle?

Acodis handles a broad range of document types including PDFs, Word files, Excel sheets, PowerPoint decks, scanned documents, images, and handwritten text. It accurately extracts data from structured, semi-structured, and unstructured formats, including complex tables, multi-page reports, and low-quality scans.

Q: Can Acodis integrate with existing systems like LIMS, QMS, or ERP?

Yes. Acodis integrates with existing enterprise systems such as LIMS, QMS, ERP, and other document or data platforms. As a SaaS solution, it supports flexible integration options including REST APIs, FTP, and other standard protocols, whether in cloud, hybrid, or on-premise environments.

Automated checks applied to digital scans of paper Batch Records accelerate your release cycles and increases RFT, without changing your whole process:

Decrease human review time by 60%
Detect issues faster and more reliably
Turn BR scans into analysable data
Ultimately, reduce deviations and improve yield

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Why Pharmaceutical companies deploy smart automation on Batch Records?

By enabling digital checks on paper batch records, smart automation dramatically frees up time of in pharmaceutical quality management and enables the team to focus on the high-value issues and analyses. It is a fast ROI first step towards the full digitalisation of paper batch records.

Accelerate detection of issues and save time

Automated reviews rapidly identify unconformities, missing or handwritten values, and other deviations delivering 60-80% reduction in review time while increasing detection speed and reliability.

Speed up release cycles
and deviation handling

Team collaboration is fostered by the ability to comment, tag and highlight deviations directly in the document so that deviation investigation time can be cut significantly.

Reduce deviations and improve yield

Turning PDF documents into machine-readable data enables organizations run analytics and implement targeted corrective actions, resulting in improved batch yield and overall product quality.

How you can achieve massive productivity gains with limited setup:

Smart automation of batch records can be implemented on your current processes, based on paper scans or pdfs, tackling many small and repetitive tasks. Beyond a clear productivity ROI, smart automation frees up time for the Quality team and enables analytical breakthrough.

Feed batch record documents through QMS & LIMS integrations, emails or drop-in

Let the algorithms run compliance checks such as signature, values and process steps

Set up instant alerts with your own trigger

Review all non-conformities in the documents and tag colleagues

Get draft deviation forms and summaries ready to share

Get the whole content in structured data form for further analysis and LLM processing

Let the machines do the basic checks

The trained algorithms understand the instructions and check all the values and steps. Values out of range, missing steps or handwritten annotations are flagged in an issue list, ready for processing.

Add your own customizable checks
Besides standard checks, create business rules and alerts specific to your requirement and internal language.

Simplify actions to finalise the review

Trigger collaboration with colleagues directly in the document in 2 clicks. In case of deviations, get a draft deviation form. To run the investigation, use smart search to locate information in the current and previous batches.

And when the review is ready, get a summary of the information to share to stakeholders. A standardised output that feed into your PQRs.

Reduce deviations and improve the yield

Each time your batch record documents are processed, a digital twin in structured xml format is created including all the table values, with their context and metadata. This enables further analyses to spot correlations, support deviation management and create new insights leading to less deviations and improved yields.

How Smart Automation Paves the Way to further digitalisation and EBR

Automated Reviews are easier to setup than fully integrated EBR systems, but they are also a first step towards digital Batch Records (paper-on-glass) and EBR implementation

Automate Current Documents

Smart Automation of current paper and pdf Batch Records enables large time savings on the Batch Review and downstream quality processes, without requiring complex process transformation.

Digital Batch Records

Also called "paper-on-glass", digital batch records enable standardised formatting for inputs and real-time validation & alerts. Digital MBR can be seamlessly created from the Smart Automation step.

Transition to integrated EBR

Integrate MES and machine sensor inputs into the digital Batch Records to create a fully integrated EBR system, providing maximum automation and data consistency.

The Value that Gets Budget Approved

Let's talk numbers, because that's what gets digital transformation projects approved.

Direct time and value savings

6,000 hours of review time saved annually

€540,000

2,000 hours saved on investigations & follow-up

€180,000

2,000 hours saved on internal document drafting

€180,000

Indirect Value

Batch release time: 15 → 11 days (25% improvement)

€480,000

Improved compliance (~1% of QA budget)

€280,000

Total annual value

€1,660,000

Based on Machine Learning Models Tailored to Quality & Regulatory Needs

GxP compliance by design, providing full traceability, auditability and replicability in compliance with 21 CFR Part 11 and the EU Annex 11

Highest accuracy for complex documents, through document & table specific models

Models are fine-tuned on your data for precision and privacy. Your models, your data.

Human-in-the-loop interfaces to ensure validity and compliance of data and models

Traceability back to the source, for auditing and versioning, and avoiding the risk of hallucination

Phased implementation is the key for a quick ROI and long-term scalability

Breaking down complexity in steps:

1/ Initial feasibility and scoping: 3 weeks

Running test documents
Aligning on objectives and implementation

2/ Implement the first solution: 1 month

Implement solution of a first product
Configurate rules and actions

3/ Define implementation: 3 months

Take user feedback to improve the solution and configuration
Define path and integration for scaling-up
Validate the solution

4/ Roll out across products: 3 months

Build integrations and train users
Roll-out across products and teams

Typical industry challenges

EBR is a huge investment and may not even be possible in certain facilities

Given GMP requirements, full automation systems are not allowed

Standard solutions don't work in our processes

Our data and processes are too sensitive to be shared.

How we solve it

Smart automation is based on your current documents

Tasks are automated but humans keep full control of the final outputs

Models train on your data for accuracy and apply your own instructions

Models dedicated to you run in your own instance. Nothing is shared.

What Do our Customers Say about Acodis?

The user friendly interface was simple to operate and did not require data engineering expertise.

Shannon M.

Digital Project Manager, Pharma

Very easy and fast implementation with different connection possibilities.
Excellent Customer Service, a fast response time and solution

Vinyo D.

Project Manager IT

An outstanding data extraction solution—intuitive, flexible, and backed by excellent technical support. The team’s responsiveness and expertise made all the difference. Highly recommended!

George B.

Quality Manager, Pharma

Document processing solution to extract data from static documents for non-expert users

Thomas H.

Business Architect, Agrochemical

Frequently asked questions

What is the difference between smart document automation and EBR?

Whilst EBR involves end-to-end digitalisation and sensor integration across the production line, smart automation applies to existing documents. Using scans of paper batch record or pdf machine reports. Hence it can be deployed on current processes and provide a quick ROI.

It is a first step in paper batch record digitalization which leads all the way to EBR in a progressive manner.

In addition, smart automation can be deployed on historical data and documents, thereby creating one large corpus of data. That enables firstly to quickly identify similar deviations across time, retrieve associated CAPAs and investigations. Secondly, it enables to conduct trend and correlations analyses, leading to reduced deviations and improved yields.

How can an automated system provide GxP compliance in relation to Batch Records?

Smart automation is different from full automation. It's more like an assistant who prepares the review for the Quality experts. For instance, it can automatically check for signatures, batch numbers and certain values. But handwritten annotations will need to be reviewed by humans. The goal is not to remove human oversight, but to enable the Quality experts to review the batch documents in 2 hours instead of 5. And to digitalise the data, which enables further productivity and analytical benefits.

Our systems are built with GxP, GAMP 5, 21 CFR Part 11 and the European Annex 11 in mind. This includes many attributes around reliability, traceability and audit logs. In relation to AI models, this also means relying only on locked-step, deterministic machine learning models for in-production usage.

See our approach to GxP Validation

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.

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.

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. As a SaaS solution, it 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 to accelerate Batch Record reviews in Pharma?