Solution: Structure change management with enaio®

Ready for Any Change

Change management with enaio®

Making changes to organizational processes and workflows is without a doubt one of the most complex projects undertaken at any company, especially if they relate to the quality and safety of products. When carrying out such a project, it is necessary to create detailed, end-to-end documentation of every change.

The best-practice solution for change management from enaio® enables you to fulfill official requirements and plan, implement, and monitor them efficiently.

The combination of workflow-managed processes and structured document storage are critical advantages. The enaio® workflow management solution reliably manages processes, measures, and reports. Conversely, vast quantities of logs, correspondence, reports, and documentation are generated despite all efforts to prevent this – and these all need to be managed centrally.

Core components of the enaio® solution

  • Change request
  • Review and assess (change board)
  • Manage analysis, implementation, and effectiveness audit actions
  • Controlling
  • Research and analysis
  • Record creation

The process of a change process
enaio® workflows ensure transpareny

Document storage

Universal availability of key documents is constantly guaranteed.

Workflow management

Reliably manage processes, measures, and reports.


Easy to connect to other quality management applications from enaio®.

Digital archiving solutions

Archiving solutions need to uphold statutory deadlines. enaio® supports you with this challenging task.

Always ready to report

Are you looking to find out what happened? Thanks to user-defined templates, you can individually configure when a report must be compiled and generate a report each time a change is required. In addition, all reports are securely archived.

From Risk Assessment to Data Integrity

enaio® helps you make decisions

Despite its complexity, change management is only one part of company-wide quality management. That’s why this best-practice solution is able to interact with the other solutions in the enaio® quality management suite. Documents from other applications can be interlinked with ease and, in some cases, automatically. Deviations and complaints, which often trigger changes, can also be linked. Along with that, device and test equipment data as well as the associated maintenance work can be incorporated.

  • Complex, event-based workflows
  • Managed process flow
  • Reminder function
  • Escalation management
  • Configurable action management for implementation
  • Microsoft Office integration

Risk-based approach

Risk assessments are taking on an increasingly important role when it comes to carrying out quality-related activities. Verification that a risk evaluation was carried out must be available at all times, especially when changes are made to processes.

The best-practice change management solution also supports the administration of the corresponding forms and workflow-driven action management.

  • Long-term, secure archiving
  • Templates for routine activities
  • Comprehensive reporting and statistical functions
  • End-to-end logging (audit trail) with graphic visualization
  • Simple electronic signature
  • Context-related storage of all relevant workflow data

enaio® Ensures Data Integrity

Decisions need to be made all the time during the change process.

  • Is it possible to continue to pursue the goal? 
  • Is the level of risk manageable? 
  • Have each of affected areas been sufficiently analyzed?

The answers to these questions can be found in the data and documents in the change record. You do, however, need to know that you can rely on the integrity of the data. According to the recognized ALCOA concept, data must be attributable, legible, contemporaneous, original, and accurate. With the enaio® best-practice solutions, you can rely on the fact that you will comply with these rules.

  • Implementation of the ALCOA concept
  • Change record provides an overview of processes

  • “enaio® helps to optimize company-wide processes by structuring, standardizing, and thus simplifying them.”

    Wolfgang Gleiniger
    Allergopharma GmbH & Co. KG
  • “As the central industry association in a highly dynamic sector, the National Association of Statutory Health Insurance Funds (GKV-Spitzenverband) is constantly evolving. That’s why we’ve decided to use ECM technologies to continue efforts to further optimize our organizational and process structures.”

    Gabriele Fink
    Project Manager