Adlib Becomes A Key Component For Global Regulatory Processes At An In-Vitro Diagnostics Manufacturing Leader

OVERVIEW

A Switzerland-based diagnostic company is a leader in the development and production of in-vitro diagnostic instruments and associated reagents for the early detection, screening, evaluation, and monitoring of diseases. The company is active in all healthcare market segments, from scientific research and clinical laboratory systems to patient self-monitoring, offering products for organizations with wide-ranging needs and throughput requirements.

CHALLENGE

Legacy Document Management System Replacement

The company has extensive requirements for document management and storage to support its entire product lifecycle – from research, idea creation, and patent application, to product development, proof-of-concept, and user acceptance testing, and finally to the supply chain, production, and ongoing quality assurance.

In addition, because the company develops products for in-vitro testing, the processes making up its product 'process chain' must be validated, and associated regulated documents tightly controlled, in accordance with numerous regulatory bodies, including the U.S. Food and Drug Administration (FDA). This places significant additional demands on the firm’s document management environment. Part 11 of Title 21 of the U.S. Code of Federal Regulations (21 CFR Part 11) set by the FDA, for example, specifies requirements related to document audit trails and the use of electronic signatures, to name just two.

To better address stringent regulatory and document validation requirements and to give users access to a more robust set of features, the company decided to replace its older, legacy document management systems (DMS) with a new system based on the latest technology.

“Up to that point, we had been using a mixed bag of systems throughout the company,” says the Head of Information & Document Management at their Global Informatics, who explains that this resulted from merger and acquisition activity and deployment of individual, local systems by independent business units. “We wanted to have a single ‘global system’ capable of supporting all our global processes.”

SOLUTION

Chosen for High-Quality Conversion

The company first undertook a ‘working proof of concept’ for a new DMS based on using Microsoft SharePoint for document management and collaboration, along with integration of Adlib Software for automated PDF rendering and publishing. This was conducted as a production test within the IT Department.

According to the Head of Information & Document Management at their Global Informatics, they first became familiar with Adlib when their previous DMS solution provider chose to embed Adlib technology within its Documentum solution after the company conducted extensive proof-of-concept and certification testing with Adlib and a competitive product. With support from Adlib’s development team, the company developed a special solution for the required deep integration of Adlib with SharePoint.

“We chose Adlib due to its architecture and the rendering quality. Maintaining a high standard of rendering quality is very important to us as it relates to converting all known file types into PDF, and we saw that Adlib was continuing to evolve in the right direction to maintain that high-quality conversion process.”
- Head of Information & Document Management

The test in IT went well and showed that SharePoint and Adlib were capable of delivering what they needed – the system is still in use there today. However, because the company’s location in Switzerland had been having great success for a number of years with a DMS based on the document management component of SAP’s Product Lifecycle Management (PLM) application, the company decided to base its new global DMS on a hybrid solution combining the strengths of SharePoint, SAP PLM, and Adlib.

GLOBAL ROLLOUT & MIGRATION

The company deployed its new hybrid DMS – SharePoint, SAP PLM, and Adlib – as a centered instance installed in Germany, with additional caching services for SharePoint and SAP PLM running in other locations throughout the world.

Rollout to users, which total roughly 12,000, has been taking place on a business-unit-by-business-unit basis throughout European locations, with Documentum-based systems replaced first along with any other legacy systems that are easy to migrate.

RESULTS

One challenge the company's and Adlib's teams faced pertained to the use of the company’s internal document font set and the potential impact it could have on the PDF rendering process. The company requires the use of a lot of special symbols and Greek characters, resulting in a very large font table that Adlib needed to be able to render correctly for each font type and size. Configuring the Adlib Software correctly for the DMS architecture mitigated any problem that may have arisen and prevented any character replacement from occurring.

Rendering Speed & Quality Hugely Beneficial

The company is well along the way toward achieving its primary strategic goal of replacing most of its legacy document management systems.

“With Adlib currently running as part of our new DMS, we have plenty of PDF rendering capacity and have not faced any performance or throughput obstacles,” states the Head of Information & Document Management at their Global Informatics.

At this point in the rollout, the DMS is hosting 8,000 new documents per month, each of which requires an average of five PDF renditions to cover intermediate review and approval states, totaling 40,000 renditions monthly. The speed of the Adlib rendering, which takes only seconds, is helping the company meet aggressive target turnaround times for various document workflows. According to the Head of Information & Document Management at their Global Informatics, 40,000 PDF document renditions over the course of a whole month is not very many; however, they often experience peaks during which as many as 200 documents are being run through the rendering workflow at the same time.

“Fortunately, Adlib scales and can be quickly and easily ramped up or down to handle whatever peak workload we may have,” states the Head of Information & Document Management at their Global Informatics.

In addition to the speed of the process, the company is equally enthusiastic about how Adlib technology enables them to maintain a high standard of document integrity when converting all different file formats into PDF.

“A high standard of rendering quality makes us very confident about the likely outcome of an FDA audit, for example, and virtually eliminates any likelihood we’ll need to spend money to solve problems as a result of such an audit,”
‍- Head of Information & Document Management at their Global Informatics.

He concludes by saying that the company will soon be looking at how Adlib can help them address a future requirement to archive documents in the de facto PDF/A archiving standard so that product documentation can be retrieved and properly read even after periods of 20 years or more.