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.
  • 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.
  • 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.
  • 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.
    • 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.

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.

Our Partners

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

Quick Contact

All fields marked with * are mandatory.
Please read our privacy policy.