d.velop Life Sciences:
Then discover our supplementary QM solutions now allowing you to modularly expand your basic system.
d.velop Life Sciences:
Discover our new MDR-compliant solution now for creating and updating your technical documentation.
d.velop Life Sciences:
d.velop Life Sciences has been certified as an «Attractive Employer» by Great Place to Work®
GxP-compliant software for your document & quality management
Control of records
and archiving
Archive your documents with d.3 life sciences, our solution suite, which is based on the proven d.3ecm by 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 d.3 life sciences, our solution suite, which is based on the proven d.3ecm by 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
Whether work / process instructions (SOPs), process descriptions, test specifications or other types of documents — you can create, revise and sign them all digitally with this module.
Training Management
Extend the “Document Control” module to actively plan and record the qualifications of your employees with our training management.
E‑learning
Use the new module “E‑Learning” to train your employees digitally. Create an e‑learning course according to your wishes using Microsoft PowerPoint or integrate existing presentations.
Document Control
Whether work / process instructions (SOPs), process descriptions, test specifications or other types of documents — you can create, revise and sign them all digitally with this module.
Training Management
Extend the “Document Control” module to actively plan and record the qualifications of your employees with our training management.
E‑learning
Use the new module “E‑Learning” to train your employees digitally. Create an e‑learning course according to your wishes using Microsoft PowerPoint or integrate existing presentations.
QM Workflows (Complaint | DC | CAPA | CC)
Digitalize your ISO processes. Control your production-related QM processes using digital workflows.
QM Workflows (Complaint | DC | CAPA | CC)
Digitalize your ISO processes. Control your production-related QM processes using digital workflows.
Technical Documentation
Create and update your technical documentation, e.g. in accordance with the requirements of the Medical Device Regulation (MDR).
Contract Management
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
Create and update your technical documentation, e.g. in accordance with the requirements of the Medical Device Regulation (MDR).
Contract Management
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
eQMS goes live in a record time of three to five months at Aristo Pharma Group companies
The Aristo Pharma Group introduces the document and quality management system of d.velop Life Sciences to further companies of the group in a record time
A partnership that stands for quality: d.velop Life Sciences and YAVEON
“Complement each other.” The principle that stands for good software projects with customers counts just as much when working with partners. The d.velop Life Sciences
2020 — A successful year for d.velop Life Sciences
Most likely, none of us will ever forget 2020. A virus kept the world in suspense. The pandemic has presented us all with many challenges.
Customers trust d.velop life sciences
The quality of our work has many names. In the following you will find a small excerpt from our customer list of about 100 companies from various industries. We would like to thank our customers for their confidence in us and our solutions.
“d.velop Life Sciences GmbH supported us with professionalism and expertise while we migrated to a new electronic quality management system in record time. Six independent document management systems were transferred into one harmonized central d.3 eQMS. The support in implementing the validation requirements for computer-based systems according to GxP and ISO requirements is excellent. The modules “Document Control”, “Employee Qualification”, “Deviation Control”, “CAPA” and “Change Control” are globally operated at SCHOTT AG and by integrating additional tools in quality management, the portfolio could be improved beyond Document Control. We are building on the positive experiences of the cooperation and will continue the good partnership and good cooperation with other topics.”
“Together with the team of d.velop Life Sciences, we have implemented our new DMS and training tool in compliance with GMP in a very short time. Thanks 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. By implementing the DMS and MQM and the commitment of d.velop, we have mastered a big step towards system optimization. The team of Hennig Arzneimittel says: “Thank you and we would be glad to do it again!”
“We have been a customer from the very beginning and d.velop Life Sciences supports us reliably and sustainably with their products and thus helps us to further develop our QMS and to implement electronic solutions / workflows regarding the requirements for data integrity”
“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.
“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.”
“As an automotive supplier, we really do have very 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 of d.velop Life Sciences can do, we did not even look any further. Everything is now transparently documented, versioned, archived and traceable.”
“The consultants of d.velop Life Sciences were extremely competent and the project was completed within the planned time and cost frame. 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 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.”
“The introduction of a DMS including the GMP modules Controlled Documents and EQM for our entire group of companies with a total of seven locations was gladly accepted as a great challenge on the part of d.velop Life Sciences and was mastered professionally and on schedule. The very good preparation by d.velop Life Sciences helped us to implement the modules in a very short time. The acceptance of the employees can be seen as a proof for the success of the implementation. We are already looking forward to further cooperation in the introduction of further modules (Change Control, Deviation Control, CAPA) in order to further successfully increase our efficiency.”
“We have been working together with d.velop AG very successfully and contentedly for years. Looking for a reliable partner for the technical documentation of our medical products, we stumbled upon the life science 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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