eQMS with enaio®: Digital quality management, audit-ready at all times.
Document control, training, CAPA, change control, audits and suppliers on one platform instead of scattered across Excel, email and paper files.
- All quality processes on one platform, modular start
- Audit trail, versioning and electronic signatures
- Validation according to GAMP, with full support on request
Your personal eQMS live demo
Six quick clicks, then we'll show you your own processes in the system.
Which area is your top priority right now?Question 1 of 6
Quality leaders in pharma and medical technology rely on enaio®
Does this sound familiar?
Quality processes often grow over the years. That works until the next audit is due, a new site is added or a deviation escalates.
Which version is valid?
SOPs and work instructions exist in several versions on the file server and in email attachments.
CAPA in Excel lists
Actions, deadlines and owners sit in spreadsheets that only one person truly understands.
Training records in binders
Who was trained on which version, and when? Answering that takes time, every single time.
Audits as a major project
Evidence is gathered from many sources instead of being available at the push of a button.
Approvals by email
Reviews and approvals are hard to trace, at every inspection all over again.
Every site works differently
Without a central platform, you end up with isolated solutions instead of consistent processes.
In regulated industries, the rule is simple: if it isn't documented, it didn't happen.
An eQMS in which everything is connected
The eQMS based on enaio® brings quality-relevant documents, workflows, tasks and electronic files together on one central platform. Modular, expandable and integrated into your existing system landscape via interfaces.
- One system instead of isolated solutions and Excel lists
- Modular start, expandable step by step
- Integration with SAP S/4HANA, proALPHA, Microsoft Dynamics
One platform.
How the processes interlock, for example:
Deviation recorded
Reported, assessed and documented centrally
CAPA triggered
Action with owner and deadline
SOP revised
Reviewed and approved via change control
Training assigned
Automatically to all affected employees
Audit-ready
Complete evidence with audit trail
What changes with the eQMS
All quality processes. One platform.
Start with one module and expand step by step, without switching systems.
Documents & training
Document control
Create, review, approve, revise and retire SOPs, work instructions and specifications. Including automatic reminders for due revisions and controlled printing with watermarks.
Training management
With every approval, the affected employees automatically receive their training. Read confirmations and comprehension questions document who was trained on which version, and when.
Technical documentation
Control technical files and dossiers across the entire product lifecycle: from development and release to production and post-market surveillance.
Deviations, changes & risks
Deviation & CAPA
Record deviations centrally, analyze root causes and track corrective and preventive actions end to end. With reports that reveal recurring issues.
Change management
Assess changes to processes, products, equipment or suppliers in a controlled way, check risks, plan actions, approve and document.
Risk management
Identify risks early, assess them consistently and manage suitable actions traceably.
Audits, suppliers & complaints
Audit management
Plan, conduct and document audits in a structured way. Link findings directly to actions and track evidence centrally.
Supplier quality management
Qualify and evaluate suppliers and manage quality-related actions traceably.
Complaint management
Record complaints faster, analyze root causes and use the insights to improve products and processes.
Production & integration
Equipment & test device management
Meet maintenance, calibration and inspection dates, see equipment status at a glance and avoid using blocked test devices.
Manufacturing & batch documentation
Digitize paper-based manufacturing and batch records via QR and barcodes, reduce recording errors and provide evidence faster.
Integration with your ERP
Link quality data directly to items, batches, suppliers and orders via interfaces to SAP S/4HANA, proALPHA or Microsoft Dynamics.
See your own processes in the eQMS
In the free live demo, we show you what your document control, CAPA or audits look like in enaio®. No obligation and no preparation needed on your side.
Built for GxP. Validation from a single source.
Our best-practice solutions are developed for GxP conditions and designed to meet FDA and ISO 13485 requirements. We provide validation documentation according to GAMP and, on request, support the complete computer system validation (CSV), including the validation master plan.
Complete audit trail
Every change, review and approval is logged: who, what and when.
Electronic signature
Sign approvals digitally, securely and from anywhere.
Data integrity
Audit-proof archiving and complete data integrity.
Validation documentation
URS, FS, IQ and OQ according to GAMP, including support for the validation process.
Roles & permissions
Fine-grained permissions: everyone sees exactly what they are allowed to see.
German & English
Multilingual as standard, ideal for international sites.
Compliance always results from the interplay of system, processes and validation. We support you with all three.
What customers in regulated industries say
Real voices from companies that have digitized their quality management with enaio®.
„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.“
„With enaio® eDMS, we have created a central knowledge platform that consolidates all relevant documents and makes information easy to find. Workflows and logs help strengthen our compliance. Going forward, we expect change and deviation management to lead to even more efficient and transparent processes.“
„enaio®, combined with BPL document management, allows us to share documents easily and securely and to keep track of the entire process at all times. This also includes the storage of our suppliers’ contracts.“
„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.“
„enaio®, as a company-wide solution, has already been successfully implemented in China, Germany, and Switzerland. The project implementation has been thoroughly impressive to us—from the project’s start to the present. At every stage of the project, we were supported by knowledgeable contacts and consistently pleasant communication.“
„Quality management that brings people together! By using enaio® best-practice solutions, we are able to implement cross-functional processes efficiently and transparently.“
Your eQMS in three steps
- 1
Free live demo
You tell us about your processes, we show you what they look like in the eQMS. Online and with no obligation.
- 2
Your roadmap
Together we decide which module to start with, usually where the greatest effort arises today.
- 3
Productive quickly
Preconfigured best-practice solutions instead of custom development: individual modules have been implemented at customers in the standard version within just 14 days.
AI support with lumee®
lumee® adds AI functions to your eQMS for everyday work with quality-relevant information. The AI uses only your own company data, respects existing permissions and shows the source of every answer.
In regulated processes, AI-generated answers should always be checked against the original sources.
Summarize
Grasp key content from SOPs, audit reports and specifications faster.
Research
Find information precisely, across all relevant documents.
Compare
Easily compare documents and content with each other.
Your specialist for quality management in regulated industries
OPTIMAL SYSTEMS Bielefeld has been digitizing document- and process-based workflows since 2006, with a clear focus on quality management and regulated industries such as medical technology, pharmaceuticals and chemicals.
As an independent company of the OPTIMAL SYSTEMS Group, part of the KYOCERA Document Solutions Group since 2020, we combine an established platform with personal support from dedicated contacts in Bielefeld, Germany.
eQMS in Pharma and Medical Technology
What an eQMS needs to deliver, what GMP, ISO 13485 and the MDR require, and what to look out for when selecting and introducing a system.
- The core functions of an eQMS at a glance
- 10 selection criteria, from validatability to integration
- Success factors and typical pitfalls of implementation
Answers to frequently asked questions
What is an eQMS, and how does it differ from a DMS?
An eQMS (electronic quality management system) is software for managing, documenting and monitoring quality processes digitally. A classic document management system mainly manages documents. An eQMS also maps the processes around quality: workflows, responsibilities, deadlines, escalations, electronic signatures, audit trails and reports. Because the eQMS is built on the enaio® platform, you get both in one system.
What does the live demo cost?
Nothing. The demo is free of charge and comes with no obligation. You get to know the system, ask your questions and receive an assessment of the most sensible way to start. What you do with it afterwards is entirely up to you.
Which companies is the eQMS with enaio® suitable for?
For any company that needs to demonstrate quality, especially in medical technology, pharmaceuticals and chemicals, and for their suppliers. Manufacturers with ISO 9001 certification, frequent customer audits or several sites benefit as well. Our customers range from mid-sized companies to large enterprises.
Which standards and regulations are supported?
The solutions are developed for GxP conditions and designed to meet FDA and ISO 13485 requirements. They support the implementation of requirements from ISO 9001, the EU MDR and GMP, among others. Audit trail, electronic signature, versioning and role and permission concepts are built in.
Can the eQMS be validated?
Yes. We provide validation documentation according to GAMP, such as URS, FS, IQ and OQ. On request, we support the complete validation process (computer system validation), including the validation master plan. Our advice: plan validation from the start of the project, not at the end.
Do we have to introduce all modules at once?
No, and we advise against it. A step-by-step approach is usually more successful in practice. A proven starting point is document control and training management. CAPA, change management, audit management and other modules can then be added on the same platform.
How quickly can we get started?
The best-practice solutions are standardized and preconfigured. Individual solutions have been implemented at customers in the standard version within 14 days, and in some cases only one month passed between the software test and productive use. We'll gladly discuss the timeline for your project in the demo.
Can the eQMS be connected to our ERP system?
Yes. Interfaces to ERP systems such as SAP S/4HANA, proALPHA or Microsoft Dynamics let you link quality data directly to items, batches, suppliers, production orders and complaints. Other systems can be connected via the enaio® REST interface.
We already use enaio®. Can we add the eQMS?
Yes. The eQMS is based on enaio®. You simply extend your existing platform with the quality processes you need.
Does the system run in the cloud or on our premises?
Both are possible: in your own infrastructure or in the cloud. This way, operation fits your IT, security and compliance requirements.
Get your quality management ready for the next audit
Experience the eQMS based on enaio® in a personal live demo. Together, we look at your quality processes and show how they can be mapped centrally and digitally from end to end.
- Free of charge and no obligation
- Tailored to your processes and standards
- Personal contact in Bielefeld, Germany
Your personal eQMS live demo
Six quick clicks, then we'll show you your own processes in the system.
Which area is your top priority right now?Question 1 of 6