GxP-compliant software for your document & quality management
Digitalisieren Sie Ihre Prozesse für noch mehr Effizienz und Transparenz
Vollständige Berücksichtigung Ihrer spezifischen Regularien
eDMS & eQMS — eine Digitalisierungsplattform für Ihr Unternehmen
Control of documents
and archiving
Archive your documents with dls | eQMS, our solution suite based on the proven d.velop documents (formerly d.3ecm) from d.velop AG.
Regardless if offers, invoices, delivery notes, batch processing records or test records — all are stored in the central digital archive, of course in compliance with the regulatory requirements like GoBD or GxP.
Especially for GxP requirements we have expanded our archive system by electronic signature solutions according to FDA CFR Part 11 and EU GMP guidelines annex 11. For example, you can digitally release your batch documentation and digitally manage your batch record.
Document control
Our solutions are specialized in the life cycle of your specification documents and forms. If you still require paper printouts, we also control these with the help of our controlled print.
All documents are digitally managed from their creation to their invalidation. Approval workflows with electronic signature are integrated just like the publication and distribution of documents.
The system also takes care of the training management in terms of planning and documenting the adequate training of your employees for their respective task area.
QM processes
accompanying production
Control processes such as Complaints, Deviation Control, Corrective And Preventive Actions (CAPA) and Change Control with our digital workflows.
Our solutions support you in the creation of reports like e.g. PQR. Easily create statistics on frequency, criticality or lead time of your QM processes.
Provided they are authorized, also employees who are not involved in the process, have an overview of the current processes. Thus, you increase transparency and the informative value in your company.
Control of recordings and archiving
Archive your documents with dls | eQMS, our solution suite based on the proven d.velop documents (formerly d.3ecm) from d.velop AG.
Regardless if offers, invoices, delivery notes, batch processing records or test records — all are stored in the central digital archive, of course in compliance with the regulatory requirements like GoBD or GxP.
Especially for GxP requirements we have expanded our archive system by electronic signature solutions according to FDA CFR Part 11 and EU GMP guidelines annex 11. Thus, you can e.g. release your batch documentation and keep your batch record electronically.
Document control
Our solutions are specialized in the life cycle of your specification documents and forms. If you still require paper printouts, we also control these with the help of our controlled print.
All documents are managed electronically from creation until their implementation. Approval workflows with electronic signature are integrated just like the publication and distribution of documents.
The system also takes care of the training management in terms of planning and documenting the adequate training of your employees for their respective task area.
QM processes accompanying production
Control processes such as Complaints, Deviation Control, Corrective And Preventive Actions (CAPA) and Change Control with our digital workflows.
Our solutions support you in the creation of reports like e.g. PQR. Easily create statistics on frequency, criticality or lead time of your QM processes.
Provided they are authorized, also employees who are not involved in the process, have an overview of the current processes. Thus, you increase transparency and the informative value in your company.
Your path to digitalization
Document Control software
Whether work / process instructions (SOPs), process descriptions, test specifications or other document types — you can create, revise, and sign them all digitally with the document control software.
Training Management software
Extend the module “Document Control” to actively plan and log your employees’ qualifications with our training management software.
E‑learning software
Use the new “E‑learning” software to train your employees digitally. Create e‑learnings according to your wishes using Microsoft PowerPoint or integrate existing presentations.
Document Control software
Whether work / process instructions (SOPs), process descriptions, test specifications or other document types — you can create, revise, and sign them all digitally with the document control software.
Training Management software
Extend the module “Document Control” to actively plan and log your employees’ qualifications with our training management software.
E‑learning software
Use the new “E‑learning” software to train your employees digitally. Create e‑learnings according to your wishes using Microsoft PowerPoint or integrate existing presentations.
QM processes (Complaint | DC | CAPA | CC)
Digitalise your ISO processes. Control your production-related QM processes using digital workflows.
QM processes (Complaint | DC | CAPA | CC)
Digitalise your ISO processes. Control your production-related QM processes using digital workflows.
Technical Documentation software
Create and update your technical documentation, e.g. in accordance with the requirements of the Medical Device Regulation (MDR).
Contract Management software
Keep track of your contracts. Let us remind you about key dates such as termination options or renewal options in a multi-stage procedure.
Technical Documentation software
Create and update your technical documentation, e.g. in accordance with the requirements of the Medical Device Regulation (MDR).
Contract Management software
Keep track of your contracts. Let us remind you about key dates such as termination options or renewal options in a multi-stage procedure.
News
Invitation to LOUNGES 2025 in Karlsruhe — Visit us
From March 25 to 27, 2025, we will be exhibiting at LOUNGES 2025 in Karlsruhe together with our partner PTS Training Service. This prestigious event
DLS at the GAMP®5 Conference 2024: Central GAMP topics at a glance
Digital Life Sciences took part in the GAMP®5 Conference in Mannheim from December 3 to 5, 2024. This conference was aimed specifically at managers and
DLS receives award – Top Employer Medium-Sized Businesses 2025
For the sixth time in a row, Digital Life Sciences was recognised as one of the Top Employers Medium-Sized Businesses 2025. In the current issue,
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More InformationCustomers trust Digital Life Sciences
The quality of our work has many names. Below you will find a small excerpt from our client list of around 150 companies from a wide range of industries. We would like to thank our customers for their confidence in us and our solutions.
“Digital Life Sciences GmbH supported us with professionalism and expertise in record time when we switched to a new electronic quality management system. In the process, six independent document management systems were transferred to a harmonized central d.3 eQMS. The support for the implementation of validation requirements for computerized systems according to GxP and ISO requirements is excellent. The modules “Document Control”, “Employee Qualification”, “Deviation Control”, “CAPA” and “Change Control” are in use worldwide at SCHOTT AG, and the integration of further quality management tools has improved the portfolio beyond document control. We have struck up positive experiences from the collaboration and will continue the good partner cooperation with further topics.”
“As part of the digitalization offensive, Wiewelhove has not only digitalized the applicant workflow, but also processes relating to requisitions. In the past for instance, employees needing a new laptop had to enter the price and other specification into a Word file, print the document and forward it by internal mail. This procedure was not only time-consuming but also error-prone. We therefore decided to develop our own customized solution with our long-standing partner Digital Life Sciences. Once again, the colleagues were enthusiastic about the solutions and Digital Life Sciences repeatedly proved to be a competent, helpful and open development partner.”
“With the Digital Life Sciences team, we implemented our new GMP-compliant DMS and training tool in a very short time. Due to the competent consulting, a pragmatic solution for every problem was quickly found and also the dreaded data migration from our old system was successful thanks to the database specialists of d.velop. With the introduction of DMS and Training Management and the commitment of d.velop, we have taken a big step towards system optimization. The enterprise team of Hennig Arzneimittel says Thank you and we’d be pleased to do it again!”
“With the project team from Digital Life Sciences, it was possible to implement the new DMS quickly in just three months. The modular structure of the system additionally allows a coordinated step-by-step range extension. The software was quickly accepted by all employees due to its clear design, which not only simplified the processes and release cycles in a very short time, but also improved their quality.”
“As a service provider for the micronization of pharmaceutical raw materials, we at GfM have to meet the quality requirements of our customers. The introduction of d.3 with its modular structure is therefore very well suited for us to digitally map our company processes step by step and at the same time comply with the regulations. We currently manage a wide variety of document types in the system and are gradually expanding this further. We also work with compound document. Another milestone will be the training management module. The validation of the individual modules is very well structured and meets my expectations for the validation of computerized systems according to the risk-based approach.”
“Digital Life Sciences has helped us to make our paper-based processes more digital. In the past, we mainly printed out a lot of things, stamped them, signed them and transacted them on paper or with office documents. Some things had to be kept in hardcopy form for years. Today, we work with real digital documents that we can distribute with just a few clicks, regardless of whether the employees in question are currently working at home or somewhere else. Processes have become at least 20 percent faster.”
“Updating documents, reprinting, resigning, and invalidating the old documents: The flood of paperwork had completely overwhelmed us after 25 years of company history. We had seen the need to get rid of paper where we could. With the Document Control by Digital Life Sciences GmbH, we certainly save 30 to 40 percent of working time in the documentation. For example, it has become much easier to correct documents. Work has become more efficient overall. Everything is much faster and less cumbersome. Digital Life Sciences is not just a service provider, they work really great with us.”
“We have been a customer from the very beginning and Digital Life Sciences supports us reliably and sustainably with its products, helping us to further develop our QMS and map electronic solutions / workflows while taking data integrity requirements into account.”
“Digital Life Sciences worked with us to install, validate, train and introduce the eQMS in record time in a highly professional manner. A really strong performance. The software is great and helps us to significantly optimize our processes and make them more efficient.”
“Years ago, we used to track the status of documents such as work instructions, employee’s proofs of qualification, and batch reports using an Access database or on paper. However, it was tedious to keep the documents up to date and to manage them in an audit-compliant manner. in 2012, we switched to digital document control for Digital Life Sciences, which was a quantum leap. Today we can create, find, edit and agree upon documents much faster. This saves working time and costs.”
“Prior to 2016, we did have an electronic document routing system in place, but it was all not as clean and performant as it should have been. For example, we missed a good overview of which employee is trained to what extent. That’s what we have today thanks to Digital Life Sciences. This is important, for example, for an external audit. With the old system, we still had to do many things manually. With Digital Life Sciences’ eQMS solution, quality and speed have taken a leap upward.”
“The successful collaboration is characterized by a high level of consulting expertise and a partnership-based approach, which is why we see Digital Life Sciences GmbH as a long-term partner for our company.”
“In our search for a suitable system, we became aware of Digital Life Sciences. First, the controlled specification documents from quality assurance, quality control and production were jointly integrated into the life science system. We received very good support from Digital Life Sciences throughout. The software training management is currently being implemented and the change control module will be added next year. We are completely satisfied with the Digital Life Sciences system and look forward to continuing our collaboration.”
“As an automotive supplier, we have really extensive documentation obligations in quality management. In the past, such an amended regulation took a good week to circulate. We have looked at many solutions to optimize processes. But when we saw what the digitalization solutions from Digital Life Sciences can do, we looked no further. Everything is now transparently documented, versioned, archived and traceable.”
“The Digital Life Sciences consultants were extremely competent and the project was completed on time and within budget. What else could you expect? The cooperation during the development of our QM module was very good throughout and finally led to the introduction of the new Technical Documentation module at the DMG”
“Already during the first presentation of the product in our company, one could feel the bundled professional competence and the eye for a user-friendly solution at Digital Life Sciences GmbH. As part of the project implementation, user requirements were implemented quickly and to the full satisfaction of the users. We can recommend the solution with a clear conscience.”
“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 in order to successfully increase our efficiency even further.”
“The Digital Life Sciences team has been supporting us for years in making our processes more efficient and digital. In recent years, we have successfully implemented the DMS, training management and contract management in our company in compliance with GMP. We are happy to build on our positive experience with the Digital Life Sciences team and currently have numerous projects in the pipeline that will make our documentation more digital, traceable and centralized. Digital Life Sciences GmbH is a strong and long-term partner for us.”
“With its dls | eQMS, Digital Life Sciences GmbH is helping us to strategically develop our QMS and map electronic solutions / workflows in line with GMP and ISO requirements. Currently, the modules “Document Control”, “Training Management”, “Deviation Control” and “CAPA” have been implemented and the ERP system has been integrated on the interface side in order to be able to use the existing process information across systems. We are already looking forward to many exciting future projects thanks to the wide range of possibilities and the constant expansion of functions in dls | eQMS. Whether for the introduction of further document types or new modules, in order to be able to successfully further increase our efficiency and make our documentation more digital, traceable and centralized.”
“Many documents, templates or files found themselves in our Windows folder system. This was not the ideal case. We wanted that to be better, more accessible, safer and faster. Where we used to have to browse through folders, we’re now much faster. We now have more time for higher quality work. We used to have a lot of folders and needed a lot of head work. Now it’s a higher quality of work.”
“We have been working together with d.velop AG very successfully and satisfactorily for years. Looking for a reliable partner for the technical documentation of our medical products, we stumbled upon the Life Sciences Client. With the transition to the new structure of EU MDR, we were able to fully exploit the potential of the Life Sciences Client for us and thus facilitate the work of document creation and improve acceptance in the company.”
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