Structure and Acceleration in Quality Documents
The pharmaceutical industry is inherently document-intensive. In addition to the many documents required in office and production environments, there are also all kinds of R&D reports, quality documents, approval forms, meeting minutes, reports, a large number of project documents, and much more. Carbogen Amcis in Veenendaal also deals with large volumes of (digital) documents on a daily basis. We spoke with Jeroen de Jong, Manager of Risk & Compliance, about their document challenges and the solution we provided.
Our Solutions
The Challenges Surrounding Documents
Due to the document-intensive nature of its operations, a large number of systems have been developed at Carbogen Amcis over the years. They all allow users to add documents, and that was precisely the problem. These include ERP systems, document management systems, quality management systems, but above all, the storage of documents in a large number of Windows folders. Here’s what Jeroen has to say about it:
“By using all those different systems and the associated storage methods, we had made things quite difficult for each other as colleagues over time. Each department had its own folder structure, with subfolders containing even more subfolders. You had to know exactly where to find information. As a result, multiple versions of documents ended up in different locations. This made it increasingly difficult to determine which version was the correct one. That’s not what you want, especially when it comes to quality management. On top of that, many emails were stored in personal drives. The first challenge was to come up with a system that would allow us to easily retrieve these documents.”
A second challenge arose in the area of approval processes. Jeroen explains it as follows: “We have many R&D and quality documents, but they can also be quotes or, for example, sales orders that require a manager’s approval. In the R&D department in particular, a document is often read and signed for approval by five to six people. People were walking back and forth across our company grounds quite a bit. On top of that, a new printout and scan were often made after every signature. (copy of a copy, of a copy, of…) You can imagine that after six signatures, the quality of the scan left quite a lot to be desired.”
“OneXillium connected us with an excellent consultant who guided us through the process and was able to win over our employees. What appeals to me about OneXillium is that they were able to take full charge of our EIM project. They offer short lines of communication, direct communication, and a solution-oriented approach.”
Risk & Compliance Manager
The Solution Provided
Carbogen Amcis now makes it easier for everyone in the company—not just the quality department—to find documents. The solution is Enterprise Information Management (EIM) from Xtendis Online, combined with the VIDsigner module for electronic signatures.
“Metadata is a key aspect of the ERP solution. After all, you want to move away from that huge jumble of folders and back to a simple organization and easy-to-find documents. This is now possible through the use of metadata or indexing. Not only does this save time and reduce frustration among employees, but it also ensures that the right documents are always shared both within and outside the organization. We’ve also made some progress in terms of data integrity,” says Jeroen.
The Significance of the VIDsigning Module
A document archived in Xtendis can be electronically signed. First, the document is uploaded to Xtendis Online. Next, the application sends a message (including name, email address, or phone number) to someone authorized to sign. This person receives an email or text message. They then log in using 2FA (two-factor authentication). This allows them to sign the document from a PC, laptop, or smartphone by placing a signature on the screen. Once all required signatures have been collected, the document is returned to Xtendis Online with the appropriate signatures. As a result, the document is certified.
Implementation and Collaboration with OneXillium
Jeroen explains that rolling out an EIM project can be quite challenging: “When employees have been accustomed to thinking in terms of folder structures for years, it takes time and energy to explain that centralized storage combined with metadata is a better alternative.” To ensure the project’s success, he therefore recommends involving end users from the very beginning: everyone has their own way of storing documents and has different needs and expectations for an information system. That’s the only way to prevent colleagues from falling back into old filing habits.
The Future
Initially, the EIM solution Xtendis Online was implemented to support quality management. Currently, about 25 of the 90 employees are using Xtendis Online. “In the future, we plan to gradually roll out the benefits of this system to other departments as well,” Jeroen concludes.
About Carbogen Amcis
Carbogen Amcis is a member of the Dishman Carbogen Amcis Group and offers a wide range of high-quality cholesterol and vitamin D analog products. These products are manufactured at the facility in Veenendaal. Carbogen Amcis also provides services for the development and commercialization of pharmaceuticals to the pharmaceutical and biopharmaceutical industries at all stages of drug development.
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Eigen Haard isn't the only housing authority using our EIM solution, Xtendis. Learn all about it on our housing authority page, or contact us if you'd like to gain even more control over your overall information management.