How to accelerate Batch Record reviews in Pharma?

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

CLIENT CASE STUDY

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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 finalize 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 feeds into your PQRs.

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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

1

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.

2

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.

3

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.

Value model — based on a European mid-size CDMO processing 2,000 batches/year

Direct time and value savings

Indirect Value

Based on Machine Learning Models Tailored to Quality & Regulatory Needs

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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

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.

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.