Whether work / process instructions (SOPs), process descriptions, test specifications, operating instructions, contracts or any other types of documents — you can create, revise and sign them all electronically with our “Document Control” module. In the process, the document circulation is set through configuration. Different (single or multilevel) document circulations can be stored for each document template. Thus, it can be customized to your needs and procedures. The system automatically assigns corresponding “Periodic Review” tasks to the appropriate employees. The integrated reminder and escalation management system notifies when deadlines are exceeded and tasks are past their due date. The participation in the automatic document circulation is confirmed by the electronic and GxP-compliant signature. Integrated audit trails for every document increase traceability.
How can you benefit from the Document Control software?
Digital Management
Digitally manage your specification documents (e.g. work and process instructions, test specifications, hygiene plans), forms, contracts and other document types.
Dispatch at the touch of a button
Digitally handle the document distribution and the signature circulation at the touch of a button and focus on your core business.
Increased data security
Protect your data from unwanted interference by unauthorized users and from destructive forces.
Individual configuration
Let the modules be configured according to your wishes and preferences to facilitate the onboarding training of your colleagues.
Minimization of process runtimes
Save time by minimizing process runtimes for the creation, revision, release and distribution of your specification documents.
Reduction of resources
Reduce unnecessary printouts and paper on your desk. This preserves the environment and your nerves as well as saves you money.
Central information platform
Use the d.3ecm system as your central information platform on which you can retrieve all your data on short notice.
Constant availability
Access your data at any time. It does not matter where you are.
Some features of the Document Control
- Creation of regulated/controlled documents within the system based on released templates
- The templates may also be controlled documents
- Management of specification documents and form sheets
- Digital document signature using integrated GxP-compliant signature — purely software-based
- Full-text search based on document content and document attributes (meta data)
- Individual and dynamic compulsory watermark
- Easy creation of report lists
- Controlled and logged printing
- Comparison of document versions and visualization of differences
- Integrated archiving on the basis of the d.3ecm system
- Windows and web frontend
- Periodic review
Which regulations must be observed for controlled documents?
- ISO 9001:2015, Chapter 7.5
- ISO 13485:2016, Chapter 4
- FDA 21 CFR Part 11
- EU GMP Guide, Annex 11
- WHO guidelines on good practices in data and record management
- EFG-Votum V11002: Requirements regarding the electronic data storage
- EFG-Votum V11003: Requirements regarding electronic signatures and initials
Get to know our software better
All documents and their properties that match your search criteria within the DMS search are displayed here.
The d.3 life science client icon in the upper left corner opens the menu. If you choose a menu or submenu item, the corresponding results list is displayed in the Overview window.
Controlled and non-controlled documents as well as any document types and file formats can be stored by drag & drop via the Drop Zone.
For each document, a preview can be displayed in the flexibly customizable reading pane.
The application window of the d.3 life science client displays the following menu items depending on the user, licensed module and authorization:
- DMS
- My QM
- Process Participation
- Administration
- EQM
- Contract Management
- HRM
The document status differentiates between:
- Processing (red)
- In circulation (yellow)
- Released (green)
- Withdrawn (blue)
- Training phase (purple)
Documents can be found using various search criteria and attributes. The search result is displayed in a results list on the right side in a tab. Of course, a full-text search as well as a search via visual elements is also possible.
Would you like a live webcast of our software?
Get a live insight into the possibilities of the document control in just 45 minutes with a sample use case. Learn how you can electronically create, revise and sign your work/process instructions (SOPs), process descriptions, test specifications, operating instructions, contracts or any other document types by means of the solutions of d.velop Life Sciences.
33 Good reasons for a cooperation with d.velop LS
You are not convinced yet? Find out about 33 good reasons speaking for a cooperation with d.velop Life Sciences GmbH. We will show you reasons from the provider’s point of view, from the software point of view as well as other general reasons that distinguish us.
Frequently asked questions (FAQs) about Document Control
Can SOPs be divided into different categories?
Can the document circulation be configured?
Can specifications be set regarding the selection of persons for the circulation steps?
Are released QM documents automatically put into force?
Can the circulation of documents be supplemented by a periodic review?
The periodic review task can be sent to different persons or activity profiles (e.g. reviewer, approver, releaser).
How do employees receive QM documents?
Can a document be edited by several employees?
Can a numbering scheme for SOPs be configured?
How are further applicable documents and attachments managed?
Are printouts of a controlled document documented?
How is the signature implemented within the document circulation?
Are all versions of a controlled document managed?
Customer review on the Document Control
“Years ago, we used to track the status of documents such as work instructions, employee qualification records 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 the digital document control of d.velop 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.”
You might also like …
The Document Control is a component of the d.velop Life Sciences solution suite. Each product is powerful on its own, but when used together they are even better.
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 by means of digital workflows.
Quick contact
Our sales team will help you promptly and gladly.