Batch & Release Documentation Automation

Achieve clinical manufacturing excellence & compliance

Adlib automates the transformation of batch production records, validation protocols, SOPs, and quality documentation into structured, AI-ready, audit-ready content. By normalizing formats, validating against technical criteria, and integrating with QMS and MES, Adlib reduces manual QC, lowers recall and deviation risk, and accelerates batch release across highly regulated manufacturing environments.

Our process, your benefit

Every step in Adlibʼs workflow is designed to deliver accuracy, compliance, and enterprise-ready data—ensuring your most critical documents become precise,auditable, and AI-ready.

Clinical & commercial manufacturing document collection

Input

Clinical & commercial manufacturing document collection

Adlib streamlines the collection of critical manufacturing documentation (master and executed batch records, protocols, test methods, QC results, logbooks, deviations, CAPAs, and CoAs) from MES, LIMS, QMS, shared drives, and email. Everything enters a governed intake pipeline so documentation sets for each product, batch, and site are complete and traceable from the start.

Every step in Adlibʼs workflow is designed to deliver accuracy, compliance, and enterprise-ready data—ensuring your most critical documents become precise,auditable, and AI-ready.

GMP-compliant document conversion

Conversion

GMP-compliant document conversion

All manufacturing documents (scans, PDFs, images, spreadsheets, and exports from shop-floor systems) are converted into consistent, searchable, high-fidelity documents of record. Standardization supports GMP and data integrity expectations, ensuring every batch-related document is legible, technically compliant, and ready for review, release, and inspection.

Every step in Adlibʼs workflow is designed to deliver accuracy, compliance, and enterprise-ready data—ensuring your most critical documents become precise,auditable, and AI-ready.

Quality & batch data extraction

Extraction

Quality & batch data extraction

Adlib precisely extracts critical data from manufacturing documentation - batch and lot IDs, materials, equipment, operators, dates, test results, and sign-offs. Structured, accurate data feeds QMS, MES, and analytics tools, helping you monitor process performance, flag potential quality issues earlier, and maintain tight control over product safety and efficacy.

Every step in Adlibʼs workflow is designed to deliver accuracy, compliance, and enterprise-ready data—ensuring your most critical documents become precise,auditable, and AI-ready.

Compliance-focused batch documentation assembly

Assembly

Compliance-focused batch documentation assembly

The platform assembles complete batch documentation packs (executed batch records, supporting QC data, deviations, CAPAs, and CoAs) into ordered, easy-to-navigate packages aligned to your quality and regulatory expectations. Reviewers and auditors can quickly see the full history behind each batch, supporting smoother audits and faster investigations when issues arise.

Every step in Adlibʼs workflow is designed to deliver accuracy, compliance, and enterprise-ready data—ensuring your most critical documents become precise,auditable, and AI-ready.

Manufacturing compliance verification

Validation

Manufacturing compliance verification

Adlib validates that batch documentation is accurate, complete, and aligned with GMP and internal SOPs before it is treated as a record of reference. Missing pages or signatures, mismatched IDs, incomplete results, and other discrepancies are flagged so quality teams can resolve them early, reducing risk of non-compliance, recalls, or release delays.

Every step in Adlibʼs workflow is designed to deliver accuracy, compliance, and enterprise-ready data—ensuring your most critical documents become precise,auditable, and AI-ready.

Audit-ready documentation delivery

Delivery

Audit-ready documentation delivery

Validated, organized batch documentation is delivered to the right systems and stakeholders (QMS, MES, DMS/ECM, archives, and inspection workspaces) in the formats they need. Adlib keeps manufacturing records easy to find, easy to trust, and ready for regulatory inspections, partner audits, and internal reviews, helping you protect supply continuity and product quality.

Cross-System Automation

Cross-System Automation & Interoperability

Adlib works across your entire organization’s disparate data sources to read and distill all your critical documentation, from any source. It then automatically converts it all into machine-readable and compliant documents of record, and finally, deposits those standardized documents into a central database in submission- and archive-ready formats.

Other ways we can help

Clinical Trial Management

Automate clinical trial document processes

Auto-ingest and standardize trial content into compliance-ready, structured datasets; validate for completeness and priority fields; and assemble audit-ready TMF and eTMF binders, cutting cycle times, reducing audit findings, and improving AI readiness across TMF, CTMS, and DMS.

Regulatory Submission

Simplify your path to regulatory approval

Adlib standardizes and merges large dossiers, runs automated PDF and formatting checks, and assembles submission-ready packages that integrate with RIM and QMS, helping you cut preparation time by ~50% and reduce rejection and rework risk.

Batch & Release Documentation Automation

The New Way: Modernizing the foundation of document management

Ebook

AI in Life Sciences: A Practical Guide for Regulated Enterprises | Adlib

Download Adlib's free guide to AI in life sciences. Learn why AI programs stall in regulated industries, how to build a defensible AI architecture, and what your team needs to know before your next submission.

Read the Report

Ebook

Making FDA Correspondence Ready for AI Agents

Combine life-sciences-native, agentic intake with an Accuracy & Trust Layer to make regulatory correspondence automation fast, compliant, and inspection-ready.

Read the Report

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Fueling Smarter Launches with Veeva + Adlib: Veeva is the platform. Adlib is the engine.

Standardize, validate, and scale your regulated content so Veeva delivers faster submissions, cleaner audits, and AI you can trust.

Read the Report

Frequently asked questions

How does Adlib Software help organizations with compliance and governance?

Adlib Software helps organizations meet compliance and governance requirements by implementing a set of business rules upon ingesting documents across several formats to deliver a “document of record”. These business rules define the creation of a custom header-footer, watermarks and the auto-generation of a table of contents, besides combining multiple formats into a single readable-searchable PDF. The result is an audit ready document that meets compliance and governance requirements. In addition, Adlib Software’s Transform Platform also implements document security and archival features when rendering documents of record to be in compliance with such policies resident within an organization. Finally, it also provides audit trails and reporting capabilities to help organizations track and monitor document activity.

How do I know if my specific use case is a good fit for Adlib?

Your use case is usually a strong fit for Adlib if it checks three boxes:

Document-heavy and multi-format (scans, PDFs, emails, legacy files, CAD),
High-stakes for accuracy and compliance (regulators, auditors, safety, financial risk), and
Currently dependent on manual review or stitching multiple tools together.

If you have workflows like regulatory submissions, inspections, claims, incident reports, FOI/ATI responses, quality and batch records, or KYC and loan packages, Adlib can help you build an accuracy-first, AI-ready pipeline around them. Many organizations start with a single painful workflow, then expand to adjacent use cases once results are proven.

What types of industries benefit from using Adlib Software?

Adlib Software is ideal for industries that generate large volumes of unstructured data that has to be managed to mitigate compliance, operational, audit and regulatory risks. Major industries use that to leverage our capabilities are as follows:

Life Sciences, where much of the clinical trial data originates from unstructured sources and has to be managed across regulatory filings and manufacturing
Energy, where data on Upstream Assets (Wells) or Downstream Assets (Refineries) originates across CAD/CAM and multiple file formats and must be transformed to enable Asset Lifecycle Information Management
Insurance, where claims information originates across email, images and MS-Office file formats and must be managed to drive operational efficiency for Claims Processing
Financial Services, where account openings, signatures, and signatory changes, in Retail and Commercial Banking must be OCR’d. In addition, valuation models and investment banking agreements must be captured as “documents of record” for Corporate & Investment Banking
Manufacturing and Transportation, where unstructured data must be captured to have records against production and delivery
Government and Judiciary Agencies, that require the creation and retention of “documents of record” to meet legal requirements

In addition, Adlib Software is also useful for any organization that needs to manage and analyze large amounts of data in various formats.

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