The document control software for your QM

Manage documents & control them with individual workflows
For all standards and regulations
Flexible adaptation to your requirements
New: With optional AI integration for smart use

The document control software for your QM

Manage documents & control them with individual workflows
For all standards and regulations
Flexible adaptation to your requirements
New: With optional AI integration for smart use

The document control software for your QM

Manage documents & control them with individual workflows
For all standards and regulations
Flexible adaptation to your requirements
New: With optional AI integration for smart use

Get to know roXtra in a non-binding and free online presentation.

Document control or document management refers to the systematic handling of all quality-relevant documents: From creation to checking, approval, versioning, distribution and archiving or deletion. This process complies with ISO 9001:2015 "Control of documented information" and ensures transparency and auditability.

What is document control?

The term document control refers to a documented procedure that defines the entire workflow process for information within a company or organization. It therefore forms the basis for a functioning and efficient quality management system.

What is effective document control?

Document control includes all quality-relevant and company-wide documents that need to be controlled as part of a management system. These include, among others:

  • Standard operating procedures (SOPs)
  • Process and procedural instructions
  • Forms and checklists
  • Quality guidelines
  • Records and protocols

These controlled documents are subject to defined approval, amendment and archiving processes to ensure that only the current, valid version is ever in circulation. Seamless control improves traceability and ensures that employees always work with the correct information. This is a central point in internal and external audits.

What does "control of documented information" according to ISO 9001 mean?

ISO 9001:2015 largely replaces the term "document control" with the more comprehensive term "control of documented information". This refers not only to formal documents, but also to all information that a company needs to plan, implement, control and review its processes - regardless of the medium and format.

This includes structured content such as digital work instructions and tables as well as unstructured content such as emails, images or audits. The standard requires that this information:

  • are clearly identifiable (e.g. through versioning),
  • be kept up to date,
  • are adequately protected (e.g. against unauthorized access or accidental changes),
  • and can be made available in a targeted manner (distribution, access control, archiving).

A digital document management system such as roXtra helps companies to implement these requirements successfully and in an audit-proof manner.

What advantages does roXtra offer for document control?

roXtra simplifies efficient document management with a user-friendly, ISO-compliant platform that digitally maps and automates the entire document lifecycle. The most important advantages at a glance:

  • Transparent workflows: Every step, from creation to checking, approval and publication, is mapped with system support. Responsibilities are clearly defined.
  • Versioning & revision security: Old versions are automatically archived. Only the current version is in circulation.
  • Notifications & read confirmation: Users are automatically informed about new or changed documents. Read confirmations can be documented.
  • Auditability: Changes are logged in the so-called audit trails. Documents can be traced and audited at any time.
  • Access control: Only authorized persons see or edit certain documents.
  • Central platform: All documented information can be found quickly in one place using the search function or links (e.g. via perma-links on the intranet).

These functions make roXtra an effective tool for reliably fulfilling the requirements of ISO 9001, MDR, FDA or internal QM guidelines.

Overview of document control aspects

With roXtra Documents , you can create a central and structured location for all relevant company documents. The digital solution for efficient document management enables you to manage your files automatically, in compliance with standards and in a time-saving manner; from creation and approval to audit-proof archiving. Thanks to individual workflows, audit trails for greater transparency and cross-system user management, you can maintain an overview at all times and ensure clear responsibilities. This creates a lively, transparent and audit-proof quality management system that supports your entire company in the long term.

Document control software: Control documents
Document control software: cross-system user management
Document control software: Individual workflows
Document control software: distribution of relevant documents

Document control forms the backbone of an effective and standard-compliant quality management system. It ensures structured access to information, increases transparency throughout the company and creates the basis for successful audits and smooth ISO certification, e.g. in accordance with ISO 9001, ISO 13485 or GxP.

With roXtra's intuitive user interface and powerful full-text search, you can find any document in seconds. At the same time, you benefit from clearly defined workflows that can be individually adapted to your processes - including transparent control and approval processes.

The document control software helps you to manage all documents centrally throughout their entire life cycle and to control them in accordance with standards. This makes it much easier to comply with all relevant guidelines - without any additional effort in day-to-day business.

Precise answers without lengthy searches. No trial and error with keywords, no searching through extensive hit lists, just the information you need at that moment.

> Central knowledge management
> Control documents according to standards
> Archiving & auditing
> User management
> Quick search
> Distribution of documents
> Structure business processes
> File format compatibility

The roXtra software supports all common file formats - both open formats such as ODF (.odt, .ods, .odp) and proprietary formats such as Microsoft Office or PDF. This makes roXtra particularly flexible to use and enables seamless editing, versioning and integration of a wide range of document types into existing approval and workflow processes. Find out more about the integration of Libre Office in our blog post.

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