Transparency across site boundaries
“The introduction of a DMS including the GMP modules controlled documents and Training Management for our entire group of companies at the six German sites was accepted as a major challenge by Digital Life Sciences and mastered professionally and on time. The very good preparation by Digital Life Sciences helped us to implement the modules in a very short time. The employees’ acceptance proves the success of the introduction. We are already looking forward to further collaboration on the introduction of additional modules (Change Control, Deviation, CAPA) to further successfully increase our efficiency.”
Drug manufacturer Aristo Pharma creates centralized document management with dls | eQMS
Drug manufacturer Aristo Pharma manages millions of invoices as well as process descriptions, manufacturing and test specifications and contracts with the document management system dls | eQMS from Digital Life Sciences, creating transparency across the six German sites.
The original drug is too expensive for you? Fortunately, a generic product is most likely available — a so-called generic product made from an off-patent active ingredient that is offered as an affordable alternative by another manufacturer. Aristo Pharma — a Berlin-based company that emerged in 2008 from the merger of several medium-sized German pharmaceutical companies — specializes in the production of such drugs, which are high-quality yet cost-effective. A company with a growth-oriented path, which the more than 1,800 employees enthusiastically help to shape.
Increasingly important on the road to success: smooth workflows and transparency across the boundaries of individual sites. Analog data carriers such as paper are barely keeping pace. The management of millions of printed invoices as well as process descriptions, manufacturing and test specifications, and contracts becomes a test of endurance for departments and a stopper for the company. Aristo Pharma was therefore looking for a central digitization solution. The pharmaceutical company found what it was looking for at Digital Life Sciences, a specialist from Gescher near Münster, which serves around 130 customers, the majority of whom are active in medical technology or the pharmaceutical sector.
dls | eQMS enables centralized and digital document management
Aristo Pharma opted for the quality management system (QMS) dls | eQMS. The QMS platform is the technological basis of numerous d.velop products around the classification, structuring, storage and versioning of information — a kind of framework for modules allowing companies to paint their individual digitization picture. “We opted for Digital Life Sciences because dls | eQMS gives us maximum options when it comes to digitalisation,” emphasizes Dr Cornelia Beier, Head of Quality Management at Aristo Pharma. “We don’t need new software and interfaces for every workflow, but can map everything with a single system and save time and nerves on a day-to-day basis.”
Gutenberg would have been amazed: With dls | eQMS, Aristo Pharma will sooner or later be saying goodbye to paper. Previously, the sites printed out all documents — including work and process instructions, process descriptions, test specifications, operating instructions and contracts. Millions of printed documents filled the archives. Not only a waste of space, but also a waste of time. If employees wanted to work with a document, they first had to search for the position in the archive using an Excel spreadsheet. This was followed by walking, and on site, signing in and out of withdrawals — much like a library. All these steps unnecessarily wasting time. Dr. Beier: “To save this time, we introduced the document control module.”
In future, Aristo Pharma will store all documents in digital form — in dls | eQMS as a central information platform. With the Document Control module, employees can now find millions of folders and documents in seconds using a smart search function that allows filtering by attributes such as status and filing date while also searching full text. An authorization management is used to determine which employees may subsequently access which documents. The Document Control module now also provides a digital review, approval and release cycle without analog signatures.
“Employees feel relieved of tedious routine tasks”
Working with the digital documents is just as easy as searching. dls | eQMS combines related files into digital files using individually customizable attribute fields — similar to a traditional paper archive, but without the disadvantages. For example, the same document may exist in a customer folder and an order folder at the same time, since a digital folder only references a document, unlike the paper archive. Another advantage: With the document control module, tasks such as document distribution and signature circulation can be automated. A function that saves a lot of walking. “The new solution is correspondingly well received by our employees,” Dr. Beier is pleased to say. “Employees feel relieved of tedious routine tasks and save resources for more thrilling tasks.”
Time-saving contract management
Aristo Pharma also used the contract management software to archive thousands of contracts, including license agreements and non-disclosure agreements, from six sites in a central digital pool. Here, the company was already using a digitization solution. Aristo has chosen the Contract Management module in order to work in one system for the entire document management, combined with many new and convenient functionalities. If desired, the module can remind Aristo Pharma of important deadlines automatically.
In the meantime, around 1.2 million invoice documents have also been transferred to the dls | eQMS long-term memory via an interface to SAP. “This is audit-proof archiving that meets all legal requirements — including completeness, availability, access protection and retention periods,” explains Dr. Beier. “With this new archiving, we have laid the foundation for sustainable compliant work.”
The qualification management is also digitized
And the digitization journey continues. As part of the digital transformation, Aristo Pharma has decided to also map the qualification management of employees electronically — with the “Training Management” software module. Whereas quality management staff used to have to copy new specifications such as standard operating procedures (SOPs) umpteen times for upcoming training sessions, distribute them with training sheets to the areas to be trained, and then document the test results in Excel lists, the process is now carried out entirely in the software. There, subject matter experts select the employees to be trained and send them digital information materials and individual catalog of questions. “Employees then sit the exam within the software. All results are automatically documented in a qualification matrix, and the qualification level of hundreds of employees can be seen at a glance,” says Dr. Beier. “This solution also relieves us of strenuous routine tasks and creates resources that we can invest in more important tasks.”
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