Controlled Documents — GxP-compliant digitization solutions from d.velop Life Sciences GmbH
d.velop Life Sciences GmbH is your partner for GxP-compliant documentation solutions in the pharmaceutical industry, medical technology, diagnostics, healthcare sector, food industry, contract manufacturing and steel industry.
Be it Document Control , Deviation Management (DC), CAPA, Process Documentation, Digital Personnel File, Training Management, Change Management (CC) or Contract Management – our solutions are to be understood as a complementary supplement to d.3 and primarily address document-based processes of manufacturing / production and quality management.
Find out more about GxP-compliant digitization options for your documents here.
The focus of our digitization solutions is on the control of records and archiving, the control of documents, as well as on QM processes accompanying production. Whether controlled documents, digital planning and documentation of the qualification level of your employees, digitization of your ISO processes, digital contract management, the process documentation module or electronic management and archiving of your manufacturing documentation — our products have already been introduced and successfully validated in numerous companies.
Moreover, our products have been successfullyaudited in TÜV audits according to the guidelines of ISO standards 9001 and 13485 and in inspections by the regional council (Germany). We are pleased to have a customer base of over 70 customers. The majority of our customers are projects from the life sciences sector that require validation.
Controlled Documents — electronic document management minimizes process times
Every day, we deal with a large number of different documents, while furthermore, a mass of information is generated that needs to be processed quickly and reliably. In the process, countless documents are created, verified, edited, distributed, stored or destroyed. It’s good if there are rules for document control and you can manage everything in your company digitally.
With our digitization solutions you can manage your specification documents such as work and process instructions, test specifications, hygiene plans and operating instructions as well as forms, contracts and other document types fully electronically. This allows you to significantly reduce process runtimes for the creation, revision, release and distribution of your standard documents — the signature circulation and distribution of documents is done at the push of a button. In addition, redundant printouts can be reduced and at the same time the environment and nerves are spared.
Optimize the management of specification documents and forms — regulated / controlled documents are created within the system based on approved templates. The templates may also be controlled documents, themselves.
You can now sign documents electronically — our integrated GxP-compliant signature solution is purely software-based. Our digital solutions for document control also enable periodic reviews and the convenient creation of report lists. All documents receive an individual and dynamic forced watermark — also a controlled and logged printout is available. Our digitization solutions enable full text searches based on document content and document attributes (metadata) as well as integrated archiving based on the d.3ecm system.
Solutions for document control
Our d.3 solutions cannot only be used for QM processes — we offer you innovative solutions for document control which can be adapted to the life cycle of your specification documents and forms.
From creation to your cancellation, all documents are passed electronically through the software. Approval workflows with electronic signatures as well as the publication and distribution of documents can be integrated. The consistent integration of our training module completes your digitization strategy.
Our document control system meets the following regulatory requirements:
- ISO 9001:2015, Chapter 7.5
- ISO 13485:2016, Chapter 4
- FDA 21 CFR Part 11
- EU-GMP guideline, Annex 11
- WHO: “Guidance Document on Good Data and Record Management Practices”
- EFG-Votum V11002: Requirements regarding the electronic data storage
- EFG-Votum V11003: Requirements regarding electronic signatures and initials
Do you have questions about controlled documents and our digitization solutions? Then contact us — our experienced colleagues will be happy to advise you in detail about the respective specialist area.
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 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 .
Our solutions are specialized on the life cycle of its specifications and form sheets. If paper printouts are still required, we check these with our controlled printing. Within the framework of document control, all documents are managed electronically 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 pane.
With us you can always rely on professional competence and excellent customer service. We would be pleased to advise you in detail about our d.3 solution for quality management as well as our comprehensive service portfolio.
Use d.3 for your quality management and document-based processes as well — of course, we are at your disposal for a detailed consultation.
Simply contact us — we will help you with questions and concerns in a competent and friendly manner.
Convince yourself of the numerous advantages of our digitalization solutions !