Be it work/process instructions (SOPs), process descriptions, test specifications, operating instructions, contracts or any other document types — you create, revise and sign them all electronically with our “Document Control” module. The document circulation is determined by configuration. Different (single or multilevel) document circulations can be stored for each document template. Thus it can be custimized to your needs and procedures. The system automatically assigns corresponding “Periodic Review” tasks to the appropriate employees. The integrated reminder and escalation management system signals when deadlines and tasks are exceeded. 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 do 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.
Completion at the touch of a button
Handle the distribution of documents and the signature circulation digitally at the push 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 for 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 spares the environment, your nerves and your money.
Central information platform
Use the d.3ecm system as your central information platform on which you can retrieve all your data at 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 approved templates
- The templates may also be controlled documents.
- Management of specifications 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 forced watermark
- Easy creation of report lists
- Controlled and logged printing
- Comparison of document versions and visualization of differences
- Integrated archiving on the basis of 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 guideline, Annex 11
- WHO guidance 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
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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’re 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 and other general reasons that distinguish us.
Frequently asked questions (FAQs) about Document Control
Can SOPs be divided into different categories?
For the administration of QM documents, the d.3 life science client can manage the three document categories ‘QM manual, process instruction and work instruction’. These three document categories show different hierarchical levels of the QM documentation. The QM manual includes general documents like for example policies. For a more detailed description of process instructions, the QM manual refers to the two hierarchical levels below.
Can the document circulation be configured?
The document circulations (e.g. review, approval, release, training, enactment) can be flexibly configured and adapted to the requirements of the company. The circulation is linked to the document template, so a different circulation could be defined for each template.
Can specifications be set for the steps in the circulation for the selection of persons?
For the individual steps, you can determine whether and which employees and/or employee profiles can be selected. You can determine whether a minimum or maximum number of people are involved in a step and specify a specific person/profile or make it mandatory.
Are released QM documents automatically enacted?
The enactment is always the last step in a document circulation and is usually performed automatically at the end of the scheduled training phase. It is however also possible to perform the enactment manually.
Can the circulation of documents be supplemented by a periodic review?
In a document circulation you can decide if you want to send a task for a periodic review. If a periodic check is planned, the releaser receives a proposed date based on the configuration (e.g. 2 years after the enactment) and a task for the periodic review is sent with the appropriate lead time.
The task for the periodic review can be sent to different persons or activity profiles (e.g. verifier, approver, releaser).
How do employees receive QM documents?
Independently of the additional functions in ‘Employee Qualification Management’, you can define a document distribution list, on the basis of which the ‘Binding for list’ is created for a document. If document distribution is used, a first distribution list is specified in the document circulation. With the first distribution list you select those users who, after release of the document, will receive the task for the read-and-understood training. In connection with the processing of this task, a sub-distribution option is available. The employee can distribute the document to other employees in connection with the read-and-understood training.
Can a document be edited by several employees?
A document is assigned to an author who is reserved for editing. However, the authorship can be transferred to another employee so that he or she can add further content if necessary.
Can I configure a numbering scheme for SOPs?
Using a numbering scheme a unique number can be assigned to every document in the d.3 life science client. Hierarchical numbering is also available here, which has an effect on the release processes. For example, an attachment created with a hierarchical numbering system can only be released if the superordinate document is released.
How are further applicable documents and attachments managed?
One or more further applicable documents and/or attachments can be assigned to a controlled document. They are listed in the document’s properties and in the preview and can also be accessed directly here.
You can configure that the author of a document receives a note when a document or attachment is released in a new version.
Are printouts of a controlled document documented?
With appropriate authorization, an employee can print controlled documents. During controlled printing, he or she selects the extent to which the document should be printed (additional pages with information on the audit trail, electronic signatures, etc.). He or she must specify a reason for printing and the printout is logged in the properties.
If the printout is reported as returned / destroyed, this is noted in the system using the function ‘Printout confirmation’.
How is the signature implemented within the document circulation?
An electronic signature is implemented for all actions requiring signatures (document circulation, read-and-understood tasks, etc.). It meets the requirements of the FDA and the GMP guidelines and substitutes for the personal signature on a printed document. This function enables responsible persons to provide the necessary signatures even at a distance. Each signature is recorded in the audit trail and printed on an additional page with the document.
Are all versions of a controlled document managed?
Controlled documents are managed in a minor and major versioning. There may be multiple editing versions if has rejected the check/approval/release in the document circulation. The author creates a new processing version and restarts the signature circulation. All versions of a controlled document can be viewed by authorized users. A direct document comparison of two versions is also available here.
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