Document control software: Reliable, automated, digital

Q: Can several employees edit one document?

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

Q: 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.

Q: 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.

Q: 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.

Q: 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.

Q: 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.

Q: 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.

Q: 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.

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

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.

Document Control Software: The 8 biggest benefits

Manage your documents digitally

Work and process instructions, test specifications, cleaning schedules, and much more: You control your documents digitally. Of course, this also works with forms, contract templates, and other document types.

Individual configuration

Configuration entirely according to your wishes: The modules are configured according to your concept of document control. This makes your work and the onboarding of colleagues easier.

More data security

Unwanted actions by unauthorized users and hostile actors no longer pose a threat: With document control software, your data is safe.

Get your work done with one click

Document distribution and signature circulation - you can do both with one click.

Reduced process runtimes

Less time spent on processes like creating, revising, approving, and distributing default documents means more time for your actual work.

Complete overview

Goodbye, paper chaos: Printouts and paper are a thing of the past with document control software.

Everything in one place

All your data is on one platform, namely d.3ecm. Which means you have easy access at all times and can keep an overview.

Access at all times

With document control, all your documents are available at all times. You can access them from anywhere.

The most important features of document control software

Electronic creation, qualification, controlled release, revision, archiving, and GxP-compliant 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 upcoming deadlines and pending 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

Create regulated/controlled documents on approved templates and manage forms and default documents

Audit-proof archiving, compulsory watermarking and version comparison of documents as well as output of variations

Work with Windows and web front end, create report lists with a few clicks and search your documents with full-text search

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

ISO 13485:2016, Chapter 4
EFG Vote V11002: Requirements for the retention of electronic data
EFG vote V11003: Requirements for electronic signatures and initials

FAQs: Answers to the most important questions about Document Control Software

Is it possible to configure the document circulation?

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

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

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

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?

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

Does the system document the printouts of a controlled document?

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

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