Main aspects of our digitalization solutions

Control of records and archiving

Archive your documents with d.3 life sciences, our solution suite which is built on the proven d.3 ecm of d.velop AG.

Regardless if offers, invoices, delivery notes, batch 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 on the life cycle of your specifications and form sheets. 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 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.

Production accompanying QM processes

Control processes like deviation control (DC), corrective and preventive actions (CAPA) and change control (CC) with our electronic 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 ongoing processes. Thus, you increase transparency and the informative value in your company.

Our Solutions

        • Regardless if SOPs, process descriptions, operating instructions, test instructions or other document types – with our module “Controlled Documents” you can create them, revise them and sign them electronically. Features like controlled print, dynamic watermark and periodic review are included of course.

Document Control

  • Digitally plan and document the qualification level of your employees. Our solution supports document-based trainings as well as external trainings and further trainings. The consistent integration of the training module into the module “controlled documents” completes the digitization strategy.

Training Management

  • Digitize your ISO processes.
    Digitally display deviation notifications (deviations), corrective and preventive actions (CAPAs) and change notifications (changes) from capturing until completion. Our integrated solutions now manage your previously paper-based process electronically.

DC | CC | CAPA

  • Keep track of your contracts. Get reminders for deadlines like termination or renewal options in a multi-stage process. Give every employee electronic access to those contracts which are relevant to him/her. Create new contracts on the basis of text modules – always in the current released version.

Contract Management

  • Our module process documentation supports you implementing new ISO standards like e.g. ISO 9001: 2015. Generate interactive process maps based on your database-driven process mapping – multilingual of course. Generate your process manual with a click, of course also as PDF in corporate design.

Process Documentation

    • Keep and archive your batch documentation electronically. Paper first is scanned, existing digital documents are directly stored in the batch record – no matter if deviation or CAPA reports. The release of the batch documentation can be done electronically just as the digital management of the batch record.

Batch Documentation

d.velop Life Sciences GmbH

Since 2007, the d.velop Life Sciences GmbH is the competence center of the d.velop AG for GxP compliant documentation solutions. These solutions are a complementary addition to the successful d.3ecm system of d.velop AG.

The solutions of d.velop Life Sciences GmbH primarily address document-based processes of manufacturing/production and quality management.

d.velop AG

Founded in 1992 by Christoph Pliete and Thilo Gukelberger, the d.velop AG develops and distributes software for the consistent digitization of business processes and branch-specific specialized processes.

By expanding the established d.3ecm system for document management, archiving and workflows to mobile apps and standardized and Custom SaaS solutions, the d.velop AG also offers Managed Services.

Customer Reviews

Holopack Verpackungstechnik GmbH

A high level of consulting expertise and the partner-like performance characterize the successful collaboration. We therefore see d.velop Life Sciences GmbH as a long-term partner of our company.

Silke Bacher
Project Manager DMS
Holopack Verpackungstechnik GmbH

MEDICE Arzneimittel Pütter GmbH & Co. KG

We are customers from the very beginning and d.velop Life Sciences supports us reliably and sustainably with its products and thereby helps us to further enhance our QMS and to display electronic solutions/workflows taking into account the requirements regarding the data integrity.

Silke Schwiertz
Head of QM/QA/QP
MEDICE Arzneimittel Pütter GmbH & Co. KG

Weber GmbH & Co. KG

Digitization is not a new trend for us, since we use the solutions of d.velop for more than 12 years now. With the implemented document control and integrated employee qualification management in d.3 life science, we delight our customers and auditors time and again.

Alexander Dürl
Group leader IT Application Management
Weber GmbH & Co. KG

Dr. Brill + Partner GmbH Institut für Hygiene und Mikrobiologie

The d.velop Life Sciences installed, validated, trained and introduced the eQMS in a record-breaking time and 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.

Alexander Wodrich
Marketing & Sales Manager
Dr. Brill + Partner GmbH Institut für Hygiene und Mikrobiologie

IT Consult Halle GmbH

From the very first product presentation on our premises we could sense the concentrated expertise and the perspective on user-friendly solutions in the d.velop 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.

Dirk Grupe
Sales representative
IT Consult Halle GmbH

Amann Girrbach GmbH

We have been successfully working with the d.velop AG to our full satisfaction. Looking for a reliable partner for the technical documentation of our medical products, we stumbled upon the life science client. With the migration to the new structure of the EU MDR, we could make full use the potential of the life science client and thus facilitate the work when creating documents and thus improve the acceptancy in our company.

Philipp Wildgrube
Regulatory Affairs Manager
Amann Girrbach GmbH

DMG Dental-Material Gesellschaft mbH

The consultants from d.velop Life Sciences were extremely competent and the project was implemented within the planned schedule and costs. What else could you expect? The collaboration in establishing our QM module was always very good and eventually lead to the introduction of the module Technical Documentation.

Rüdiger Stiemer
Quality management
DMG Dental-Material Gesellschaft mbH

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Contact

d.velop Life Sciences GmbH
Am Campus 13
DE-48712 Gescher

Telefon: +49 (0) 2542  20201 0
Fax: +49 (0) 2542  20201 19
E-Mail: info@dvelop-ls.de

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