Document control software: Reliable, automated, digital

What is a document control system, and how you can benefit from it

Document control means accessible standard documents that are up to date, document training that is tailored to requirements, and version control that complies with regulations. This is so easy to achieve with document control software.

Control documents
with one click

GxP-compliant signature
and audit trails

Revision-proof
archiving

Workflows
save time

dokumentenlenkungssystem-header

Process documents more easily with a document control system

There are various documents that you process regularly: Standard Operation Procedures (SOPs) and process descriptions. But also test specifications, operating instructions, or contract templates. Do you want to use other documents? No problem. You can process everything with document control software.

Electronic creation, qualification, controlled release, revision, archiving, and digital signature

Document circulation is set by configuration - both single and multi-level for each document template

Assignment of numerous "periodic review" tasks directly to employees via workflow

Reminder and escalation management reliably prompts you to meet deadlines and tasks

With an electronic and GxP-compliant signature, you confirm participation in automatic data circulation

Integrated audit trails provide high traceability of completed processes directly

Document control system: The 7 biggest benefits

Document control software:

This - and much more - awaits you:

  • Create regulated/controlled documents on approved templates
  • Manage forms and default documents
  • Sign documents digitally because your signature is integrated and GxP compliant
  • Search documents with full-text search for content and attributes
  • Take precautions with compulsory watermarking (individual and dynamic)
  • Create report lists with a few clicks
  • Compare the versions of your documents and the output of variations
  • Archive based on the d.3ecm system
  • Work with Windows and web front end

with partnerships

YAVEON relies on the QM solutions of our partner d.velop Life Sciences

Consulting expertise meets proven features: YAVEON and d.velop Life Sciences - the perfect combination. YAVEON has years of experience and expertise in the regulated environment and serves numerous clients in the pharmaceutical and medical technology industries. The d.velop Life Science modules are precisely aligned to the needs of customers from the regulated environment and provide a solid foundation. The combination of professional consulting and smooth-running products is unbeatable. Take a closer look.

Logo d.velop Life Sciences

These regulatory requirements are met by the software for document control

  • ISO 9001:2015, Chapter 7.5
  • FDA 21 CFR Part 11
  • EU-GMP Guideline, Annex 11
  • WHO Good Practice Guideline for Data and Records Management
Fulfilled regulations of document control software
  • ISO 13485:2016, Chapter 4
  • EFG Vote V11002: Requirements for the retention of electronic data
  • EFG vote V11003: Requirements for electronic signatures and initials

Curious to learn more?

YAVEON QM modules - partner solutions of d.velop life sciences

In our YAVEON QM modules factsheet, you will learn

  • how to organize controlled documents,
  • how to respond if something goes wrong,
  • how to plan and record qualifications of your employees
  • how to integrate modules and systems,
  • how to train your employees,
  • how to create a CAPA and access it repeatedly,
  • and much more.
Preview Factsheet Digital Quality Management

Questions are there to be answered.

The most important FAQs around document control software

Is it possible to configure the document circulation?

It is possible to configure and customize document workflows, such as review, approval, release, training, and enactment, to meet your organization's needs. Because the circulation is linked to the document template, a separate circulation can be defined for each template.

Can I set requirements for the people to be selected for the circulation steps?

For individual steps, you can define if an employee can be selected, and if so, which employee or employee profile. You can directly determine whether a minimum or maximum number of people participate in a step. You also specify a particular person or profile and set it as a mandatory entry.

If a QM document is released, is it automatically put into effect?

Normally, the enactment is automated at the end of the training phase. However, if required, the enactment can also be done manually.

Is it possible to add a periodic check to the document circulation?

You decide whether you want to send a task for periodic review when you circulate documents. If this is the case, an appointment proposal is sent to the approver based on the configuration. A task for periodic testing is sent out in advance.

How do the QM documents reach the respective employees?

Based on a document distribution list, which you can create and submit, the "Binding-for list" is established for a document. When using document distribution, enter an initial distributor in the document circulation. This is used to select employees who will receive a task for reading training after the document has been released - with regard to task processing, there is an option of sub-distribution. The document can be distributed to additional colleagues in conjunction with the reading training.

Can several employees edit one document?

Generally, a document is assigned to an author for editing. However, it is possible to transfer authorship.

Is it possible to store a numbering scheme for SOPs?

Yes, with a numbering scheme, you can assign a unique number to each document in the d.3 life science client.

How can I manage applicable documents, and does the management apply to all versions of a controlled document?

Documents or attachments can be assigned to controlled documents. These can be found in the properties of the document as well as in the preview. It is possible to set document authors to receive a notification when a new version of an applicable document or attachment is released. The management of controlled documents is carried out in a minor or major versioning.

Does the system document the printouts of a controlled document?

In controlled printing, an employee chooses the extent to which the document should be printed. They must specify the reason for printing the document, and the printout is logged. The "printout return" function notes in the system when the printout is reported as returned or as destroyed.

How do you sign documents as part of the document circulation process?

An electronic signature is implemented for all actions requiring a signature. FDA and GMP guidance requirements are met, and the personal signature is replaced. The system records each signature in the audit trail. On an additional page, the signature is displayed with the document.

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