Adlib's process automation optimizes clinical trials, streamlines regulatory submissions, and ensures compliant manufacturing so that you can drive innovation, accelerate time-to-market, and uphold the highest standards of patient safety and product quality.
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.
Experience faster, safer, and more effective clinical research through process automation that boosts the efficiency and accuracy of clinical trial management, from patient recruitment to data analysis.
Bring life-saving treatments to market faster. Our platform will help you streamline regulatory submissions, reduce complexity and ensure compliance with global regulatory standards.
Achieve the highest levels of quality and safety through advanced automation solutions that allow you to maintain compliant manufacturing processes and optimize production efficiency.
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Accelerate your clinical trials with targeted management solutions that streamline operations and enhance data integrity.
Adlib's document process automation helps you expertly navigate the complex regulatory landscape to achieve faster product approvals.
Our solutions will give your manufacturing process guaranteed compliance and unparalleled quality from start to finish.
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"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.
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.
Use these expert insights in your evaluation of document rendering platforms to uncover the complexities of document conversion and determine the key capabilities your ultimate choice must have.
Best Practices For An Effective Document Archival
3 Ways You Can Standardize Corporate Compliance
7 Ways Documents Of Record Ensure Compliant & Audit-Ready Enterprise Repositories
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.