Solution: SOP management and document control

Reliability Built on Standard Operating Procedures

Transparent processes with enaio®

The traditional practice of manually managing documents and associated document-based processes presents companies with tough challenges. Documents must be created and archived, deadlines and validities need to be monitored, and the availability of documents must be ensured at all times. Ever shorter revision and distribution cycles are increasingly tying up personnel resources and generate logistics-related costs. Managing documents has become a complex issue, which does not only concern SOP management in a regulated environment.

enaio® enables reliable document and process control that is digital, accounts for multiple levels, and delivers accurate results over the entire lifecycle of a document.

  • Workflow-controlled creation of template-based documents
  • Template control
  • Automatic conversion to PDF format
  • Freely customizable watermark
  • Time-controlled revision
  • Training management
  • Two-step document distribution
A SOP diagram illustrating the management process of a project.
Processes controlled from idea to result
In regulated environments, strict implementaion is required
A screen shot of a computer screen showing a document for SOP Management.

Digital processes

enaio® supplies a variety of tools from revision to PDF conversion to accompany the lifecycle of a document reliably and flexibly all the way to archiving.

A screen shot of a computer screen showing a list of tasks for SOP Management.

Clear structures

Order processing, corrective measures, or procedural instructions: Each document is assigned to the corresponding register or record. Complex search requests are a thing of the past.

Digitally Safeguard and Document Processes

When managing document flows, it is imperative to achieve optimal coordination and seamless documentation of processes. This is precisely what the digital workflows integrated in the enaio® ECM suite do. Digital workflows are used to automatically send documents from the various departments and units to the responsible persons, check them in a multi-stage process, and store them.

Various verification procedures, such as electronic signatures and logging of the individual process steps (audit trail), further contribute to meeting compliance requirements.

The ECM workflows can be used flexibly, both for structured and standardized processes as well as for individual processes that need to be constantly adapted to new conditions. An additional advantage of digital document control is that it drives knowledge transfer within the company.

Document control plays a particularly important role in regulated environments: Pharmaceutical and life science companies are subject to strict legal requirements and standards. enaio® offers special ECM solutions for SOP management in the regulated environment. These solutions fully meet the strict requirements for documentation and process reliability

OPTIMAL SYSTEMS is a qualified supplier who maintains a quality management system with compliant documentation that clearly defines the software lifecycle and project management. As such, the company helps to lessen its customers’ QA-related work. Among other things, the software solution supplies ready-made QM documents for validation.

More than 2,000 enaio® customers – that’s one of them


In order to better meet regulatory requirements and different market demands, the company introduced the enterprise content management system from OPTIMAL SYSTEMS several years ago. Paper-based processes have been mapped to a single IT system.

Do you have any further questions?