Ingest and validate clinical, regulatory, and manufacturing documents at scale, supporting faster, inspection-ready submissions and compliant, AI-ready records across TMF, RIM, QMS, and MES.
For over two decades, Adlib has processed billions of mission-critical documents for the world’s leading life sciences, energy, manufacturing, financial services, and public sector organizations.
Reusing standardized components and automating formatting/assembly cuts the time teams spend on lifecycle maintenance.
When intake, conversion, and QC of trial documents are automated, TMF/eTMF is inspection-ready much earlier in the study.
Normalized, validated batch records, CoAs, and QC results reduce the time quality teams spend reconciling documentation.
Get ready to set new benchmarks in innovation and patient care by fast-tracking research and development, meeting stringent regulatory demands, and efficiently managing manufacturing processes through the power of automation.
Accelerate trial startup and conduct by automating clinical records ingestion. Adlib auto-ingests emails and scans, converts them into searchable PDFs, extracts and validates study/site/subject data, fixes TMF gaps, and auto-assembles binders with TOCs, bookmarks, and stamps, improving audit outcomes and reducing inspection risk.
Cut submission preparation time and reduce refusals-to-file. Adlib runs pre-flight checks (PDF/A, links, page rules), auto-merges and standardizes large dossiers, and finalizes outputs with the right watermarks and signatures in a single pass, feeding RIM and eCTD workflows with consistent, technically compliant content.
Normalize batch records, CoAs, CAPA, SOPs, and equipment logs into standardized, searchable documents of record, then extract and validate lots, equipment, and critical values to speed release. Adlib also renders complex CAD content to pixel-perfect PDFs without CAD licensing, supporting audit-ready, compliant manufacturing at scale.
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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.
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.
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.
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Challenge
Legacy conversion tools couldnʼt handle the volume and complexity of engineering files, forcing constant IT intervention and delaying CAD conversions into shareable formats. Flat TIFF outputs were unsearchable and lost layer previews—slowing collaboration, creating inefficiencies, and weakening archival practices.
Solution
Safeguarded engineering Adlib improved efficiency, cut administrative overhead, and safeguarded engineering drawings to reduce legal risk. Engineers and contractors gained faster access and smoother collaboration, while IT reduced workload, support needs, and infrastructure costs with a smaller server footprint.
"We chose Adlib due to its architecture and the rendering quality." - Head of Information & Document Management
The company's existing document management systems were fragmented due to past mergers and acquisitions, leading to inconsistent processes across different business units. The need for regulatory compliance, particularly with FDA standards, required a more unified and robust system to manage and validate documents throughout the product lifecycle.
Implementing the new DMS with Adlib's automated PDF rendering has provided significant improvements in document management, offering high-quality conversion and consistent performance even during peak workloads. The solution has enhanced the company's ability to meet regulatory requirements, ensuring document integrity and compliance, while also preparing them for future needs like long-term archiving in PDF/A format.
"What took me a month to do using Adlib probably would’ve taken me a year without it." - Project Manager
The company faced inefficiencies in manually converting and merging documents for SharePoint uploads, and ensuring long-term file accessibility and versioning. The discontinuation of Microsoft InfoPath highlighted the need for a new solution that could maintain form integrity over time and accommodate policy changes, requiring PDF/A compliance for records retention.
Adlib provided a robust solution for automating the conversion and merging of forms and attachments into PDF/A, significantly reducing processing time from hours to minutes. This automation allowed the team to eliminate manual processes, ensuring accurate and compliant document retention, and enabled them to focus on core responsibilities and improvements, enhancing overall efficiency.
Solution siloes, multiple disconnected document management and publishing platforms across 100+ locations causing data and document inconsistencies.
Extreme system fragmentation across the organization’s 100+ locations was causing data and document inconsistencies. As a leading CRO which supported the development of 85% of FDA approved drugs in 2021, the organization needed to consolidate internal systems to set the standard for highest quality of clinical documentation on the market.
The company transitioned to M-Files for global document management, incorporating Adlib for critical workflow automation to ensure clinical documents comply with regulatory standards. This integration led to a highly automated, seamless documentation process that operates transparently to users, improved sponsor relations through quality and compliant deliverables, positioned the company as a market leader with increased share, and enhanced their capacity to handle more trials without expanding the clinical operations team.
“Every file type is rendered through Adlib as all materials are required to be stored as PDFs. The files we are processing can be a mixture of different things such as product specifications, ingredients, formulas, raw materials used in products, or specifics of packaging. Adlib is integrated with Enovia, our active quality management tool. We rely heavily on that tool,” – Sr. Manager Platform
This pharma manufacturer faced significant challenges in managing the diverse types of files involved in their batch delivery workflows. The necessity to render every file type into PDFs for consistent storage was complicated by the variety of materials they handled, including product specifications, ingredients, formulas, raw materials, and packaging details. This complexity made it difficult to maintain a standardized and efficient document management process, leading to process inefficiencies, documentation inconsistencies and, ultimately, a compliance risk.
Tthe company implemented Haistaq into their batch delivery, quality assurance and manufacturing workflows. Adlib's robust rendering capabilities allowed for the automatic conversion of all file types into standardized PDFs, regardless of their origin. This streamlined the document management process, ensuring that all materials, from product specifications to packaging specifics, were consistently and efficiently stored as PDFs. As a result, the company achieved greater efficiency in their workflows, improved the consistency and accessibility of their documentation, and reduced the complexity and manual effort previously required to manage diverse file types. This implementation also enhanced compliance and operational efficiency, supporting their commitment to quality and regulatory standards.
98–99% of MasterControl’s customers use Adlib’s PDF publishing engine as part of their compliance process.
MasterControl was struggling with the inefficiencies of paper-based systems and the complexity of ensuring regulatory compliance at every stage of the process. They also faced challenges with document formatting and PDF conversion, as their in-house publishing engine couldn't keep up with the growing demand, diverse file types, and stringent industry standards—leading them to partner with Adlib for a more reliable, automated solution.
MasterControl relies on Adlib to deliver compliant, pixel-perfect documents for thousands of their customers, automating PDF conversion and ensuring regulatory standards are met with speed and accuracy. As a result, they’ve improved operational efficiency, reduced compliance risks, and helped life sciences companies bring critical products to market faster, ultimately making a real impact on patients' lives.
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.
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Turn CAD, BOMs, SOPs, and supplier files into AI-ready, audit-ready intelligence inside ENOVIA. Manufacturers racing toward digital twins and AI-driven operations hit the same wall: unstructured documents that PLM can store and route, but not interpret. This whitepaper shows how ENOVIA + Adlib bridges that gap so decisions get faster, without sacrificing traceability or compliance.
Standardize, validate, and scale your regulated content so Veeva delivers faster submissions, cleaner audits, and AI you can trust.
Stop feeding your factory AI junk data. Standardize, validate, and deliver trusted inputs to PLM, MES, ERP, and LLM/RAG, then prove ROI in one quarter.
Your use case is usually a strong fit for Adlib if it checks three boxes:
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.
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.
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:
In addition, Adlib Software is also useful for any organization that needs to manage and analyze large amounts of data in various formats.