Document control with enaio®: always the valid version, every record instantly.
SOPs, procedures and work instructions move automatically through review, approval, training and revision. Instead of file servers, Excel lists and signature folders.
- Preconfigured best-practice solution, ready to use and adaptable
- Read confirmation, training and comprehension test with every release
- Audit trail and electronic signature, GxP validation available
Your personal document control live demo
Six quick clicks, then we show you your document processes in the system. If you like, you can then test it with your own documents.
What's your main goal?Question 1 of 6
Quality professionals in medical technology, pharma and industry rely on enaio®
Does this sound familiar?
Companies in regulated industries have an average of 800 to 1,500 active QM documents, many of which must be reviewed every year. With file servers and Excel, that quickly becomes a full-time job.
Which version is valid?
Copies of SOPs and work instructions sit on network drives, in inboxes and as printouts next to the machine.
An Excel list as the control center
One person maintains versions, review dates and owners by hand. If they're away, document control stalls.
Approvals by routing slip
The signature folder travels from office to office, and nobody knows where the document is right now.
Chasing read confirmations
Who has read the new version, who has been trained? The evidence is buried in lists and binders.
Missed review dates
Overdue reviews often only come to light when the auditor asks about them.
Audit preparation as a major effort
Approval history, training records and old versions take days to pull together.
A document is controlled when every step from creation to archiving is defined and documented in a traceable way.
The complete life cycle of your documents in one system
The document control best-practice solution based on enaio® takes every controlled document through a defined, logged process: from creation through review and approval to training, revision and retirement. It is preconfigured and ready to use, yet can be flexibly adapted to your requirements.
- Folder system with registers, structured like your QM manual
- Users only see valid documents, as a read-only PDF
- Authors and QM keep working in Word, with full version history
Every step recorded.
This is how it works, for example, when an SOP changes:
Revise
The author edits the Word file, co-authors contribute
Review & approve
Reviewers and approvers confirm with an electronic signature
Put into effect
The new version is distributed, the old one archived
Train
The training group automatically receives the reading assignment
Prove
Read confirmation and test result are logged
What changes with digital document control
Everything controlled documents need
Preconfigured for a fast start, adaptable to your standards, document types and workflows.
Create, review, approve
Review and approval workflows
Configurable workflows per document type with one or more reviewers and approvers. Every decision is confirmed by electronic signature and logged.
Authors & co-authors
The document owner can add co-authors at any time or hand the document over to another responsible person.
Templates & Word integration
New documents are created from templates and automatically provided as PDF. With word-sync, document number, title and version appear directly in the header and footer.
Validity & revision
Versioning & history
All previous versions remain archived. Users only see the valid version as a read-only PDF; authors and QM have access to the history.
Scheduled revision
The “Check Revision” workflow automatically reminds you of due reviews. Keep track of deadlines, validity periods and acknowledgements.
Linked documents & attachments
Link procedures with work instructions, forms and language versions. Attachments are controlled together with the document.
Training & acknowledgement
Read-and-understand and classroom training
On release, the training group automatically receives the new version. Trainers plan and document classroom sessions directly in the workflow.
Comprehension check
Single-choice questionnaires with randomly selected questions. You define the pass rate, number of questions and permitted retries.
Training overview
For every document and version, you can see who had to read it and who has already confirmed. New employees receive their training automatically.
Work & expand
Process map in the browser
Employees find documents via your process map in the web client, with clear feedback in green, yellow and red.
Controlled printing
Printouts with an individual watermark, logged and retractable if needed. No outdated printout goes unnoticed.
Analyses & reports
Deadlines, reading status, document status and training progress at a glance, graphically in the Data Visualizer Dashboard if you like.
See your document control in the system
In the free live demo, we show you what your SOPs, approvals and training look like in enaio®. If you like, you can then test it with your own documents.
What auditors want to see in your document control
Whether ISO 9001, ISO 13485, EU MDR or GMP: companies with a certified QM system need full control over their critical documents. The core requirements are similar, and they are exactly what the best-practice solution covers.
Based on ISO 9001:2015 clause 7.5, ISO 13485:2016 clause 4.2.4 and EU GMP Guide chapter 4, among others. Simplified overview; it does not replace the text of the standards.
- Before issueDocuments are reviewed for adequacy and approved.
- With every changeChanges are reviewed and approved again, and the current revision status is identified.
- At the point of useOnly valid versions are available, legible and clearly identifiable.
- After replacementObsolete documents are protected against unintended use and retained.
- At all timesEvery step is logged and can be demonstrated in an audit.
Audit-ready. Validatable. From a single source.
The solution is designed for regulated environments: it logs every step, monitors retention periods and protects your data. For GxP environments, it can optionally be validated. OPTIMAL SYSTEMS provides the validation document set and, on request, supports you through the entire validation process.
Complete audit trail
Every creation, review, approval and acknowledgement is logged: who, what, when.
Electronic signature
Sign approvals and read confirmations digitally, without paper and from anywhere.
Only valid documents visible
Users only see valid versions or those due for training, as read-only PDFs.
Roles & permissions
Built-in role assignment controls who may create, review, approve or only read.
Validation documents
Document set including URS, FS, IQ and OQ, with qualified validation consulting on request.
Multilingual
German and English as standard, further languages possible. Ideal for international sites.
OPTIMAL SYSTEMS is a qualified supplier itself, with its own QM system that clearly defines the software life cycle and project management.
What quality professionals say
Voices from companies in regulated industries that have digitized their quality management with enaio®.
„Even compared with other systems I know, it is very convenient and easy: even if you don't know the title of the document you're looking for, you always find it in enaio®.“Uses the controlled documents best-practice solution · Translated from German
„enaio®, combined with the document control BPL, allows us to approve documents easily and securely and to keep track of the entire process at all times. This also includes filing our suppliers’ contracts.“Translated from German
„With enaio®, we gain the freedom to view, create, review, and efficiently approve work instructions at any time and from anywhere—thereby supporting a modern, digital way of working, including remote work.“
„Using enaio® and the QM BPLs has made our processes significantly more efficient and easier to manage. At the same time, the system provides greater transparency for our colleagues, including those at other locations, and significantly reduces the need for paper filing.“
„This ECM solution not only meets all the criteria that matter to us. It also allows us to map our proven processes very well without having to reinvent the wheel.“Translated from German
„The specialists at OPTIMAL SYSTEMS are competent partners for us.“Uses enaio® for SOP management, among other things · Translated from German
Three steps to digital document control
- 1
Free live demo
We show you the solution based on your document types and workflows. If you like, you can then test it with your own documents.
- 2
Migrate your documents
Your existing Excel list serves as the control table: metadata is imported, files are assigned, PDFs are generated automatically and everything is full-text indexed.
- 3
Productive quickly
Thanks to the preconfiguration, you start without custom development. If required, we validate together, and later you can expand step by step to a complete eQMS.
Simply ask your QM manual
With the AI assistant lumee®, you ask questions in natural language, such as “Which work instruction covers incoming goods inspection?”, and get answers with source references. The AI only uses your company’s own data and respects existing permissions.
In regulated processes, AI-generated answers should always be checked against the original sources.
Questions & answers
Answers in natural language, always with a reference to the source document.
Summarize
Grasp the key content of long SOPs and specifications faster.
Compare
Easily compare documents and content.
Your specialist for document control in regulated industries
OPTIMAL SYSTEMS Bielefeld has been delivering enaio® projects since 2006, specializing in customers from regulated industries such as medical technology, pharmaceuticals and chemicals. Best-practice solutions for quality management are our focus.
enaio® is developed by OPTIMAL SYSTEMS GmbH in Berlin, part of the KYOCERA Document Solutions Group since 2020. You benefit from an established platform and personal support with short lines of communication, also after the rollout.
Checklist: Audit-ready document control
What ISO 9001, ISO 13485 and GMP require from your document control, which features software should offer and how to migrate your existing documents cleanly.
- Regulatory requirements in a compact overview
- Requirements checklist to tick off
- 10 questions to ask every provider
- Plus: product sheet for the best-practice solution
Answers to frequently asked questions
What is document control?
Document control defines how documents in a company are created, reviewed, approved, distributed, revised and archived. The goal is that only valid versions are in circulation and every step remains traceable. It is a core element of every certified quality management system.
How much does the live demo cost?
Nothing. The demo is free and without obligation. You see the solution based on your document types, ask your questions and get an assessment of the best way to start. If you like, we then arrange a test with your own documents.
Which documents should be controlled?
Typically the QM manual, procedures and work instructions (SOPs), forms, test instructions, specifications and technical documents. You decide which documents to control. In the solution, you manage the workflows per document type.
Aren't Excel and a file server enough?
With only a few documents, a carefully maintained manual system can work. But as the number of documents, sites or training obligations grows, the effort rises quickly, and every gap becomes visible in the audit. Software takes care of versioning, deadlines, distribution and evidence automatically.
Can we migrate our existing documents?
Yes. If your documents are on a file server and there is an Excel list with their metadata, that is a good starting point: the list serves as the control table, the metadata is imported and the files are assigned automatically. PDFs can be generated during import, and all documents are full-text indexed. Signed paper originals can be scanned and attached. In our experience, a small remainder of around 10 percent needs manual rework.
Will our authors keep working in Word?
Yes. Authors and QM edit documents in Microsoft Word as usual, based on your templates. Users see the valid version as a read-only PDF. With enaio® word-sync, details such as document number, title and version are transferred into the document automatically.
How are training and acknowledgements documented?
On release, a workflow distributes the new version to the defined training group. Each person confirms reading with an electronic signature, optionally followed by a short comprehension test. Trainers plan and document classroom sessions in the system. The training status per document and employee is available at any time.
Does the solution support ISO 9001, ISO 13485, MDR and GxP?
Yes. The solution is designed to cover the document control requirements of ISO 9001, ISO 13485, the EU MDR and GMP. Audit trail, electronic signature, versioning and roles and permissions are built in. For GxP environments, it can optionally be validated, and we provide the validation document set.
How quickly can we get started?
The best-practice solution is preconfigured and ready to use. Many customers are working productively after a short time. How long it takes for you mainly depends on your document base, customizations and any validation. You'll get a realistic estimate in the demo.
Can the solution be extended?
Yes. On the same platform you can add, for example, controlled printing, technical documentation (DHF/DMR), change management, deviation and CAPA or complaint management, all the way to a complete eQMS. If you already use enaio®, you extend your existing system.
Does it run in the cloud or on our premises?
Both are possible: in your own infrastructure or in the cloud, so operation fits your IT, security and compliance requirements.
Get your document control ready for the next audit
Experience the document control best-practice solution in a personal live demo. Based on your document types, we show you how creation, approval, training and revision work together digitally.
- Free and without obligation
- Optional test with your own documents
- Personal contact in Bielefeld, Germany
Your personal document control live demo
Six quick clicks, then we show you your document processes in the system. If you like, you can then test it with your own documents.
What's your main goal?Question 1 of 6