Adlib ingests and validates regulatory correspondence and submission documents at scale, sitting underneath the system you already run, whether that's Veeva Vault, Documentum, M-Files or other core systems, delivering faster, inspection-ready submissions and AI-ready records across TMF, RIM, QMS, and MES, with no platform migration required.
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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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.
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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 connects to every system where unstructured data originates, including ECM/DMS, email, shared drives, line-of-business applications, and legacy repositories. It reads and standardizes content from any source, in any format, then scores and validates each document against your business rules with Adlib's Trust Score before handing it off. That validated, defensible output is what feeds the AI-enabled workflow orchestrators and automation systems running downstream, and it's why straight-through-processing rates go up: the systems doing the automating are finally working from data they don't have to double-check.
Whatever system the data comes from, and whatever system acts on it, Adlib sits in between. The Accuracy & Trust layer every workflow can rely on.
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.
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Combine life-sciences-native, agentic intake with an Accuracy & Trust Layer to make regulatory correspondence automation fast, compliant, and inspection-ready.
Standardize, validate, and scale your regulated content so Veeva delivers faster submissions, cleaner audits, and AI you can trust.
No, it removes the manual assembly, formatting, and cross-checking work in front of them. Every document is validated against your business rules and traced back to its source before it reaches a person, a submission package, or an AI model.
Yes. Adlib sits underneath the regulatory and quality systems you already run, including Veeva Vault, Oracle, CARA Life Sciences, MasterControl, rendering, validating, and tracing documents before and after they enter your system of record. No migration required.
Adlib traces every rendered document back to its source page and field, applies ALCOA+ principles to AI-ready records, and keeps a full audit trail of what was validated and when, so if an inspector or auditor asks where an answer came from, you can show them.
Both. Adlib is used by large multinational pharma running global submission programs, as well as mid-market pharma and biotech, funded pre-commercial biotech building a regulatory function for the first time, and small-to-midsize CROs managing submissions across multiple sponsors.
Protocols, clinical study reports, batch and release records, regulatory correspondence, CMC data, labeling, and multi-hundred-page submission dossiers, across TMF, RIM, QMS, and MES, in whatever format they arrive.
