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

Processes controlled from idea to result
In regulated environments, strict implementaion is required

Centralized
access

Documents are available from any location around the clock, are always up to date, and are securely archived thanks to a central database.

Keeping a steady eye on deadlines

Monitoring of deadlines, confirmations of notice, in-person training, including a reminder function.

Convenient
working

Template-based creation of Word documents & auto-conversion to PDF.

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.

Reliable revision

Always keep an eye on the current status and editing history of a document in order to enable full traceability: enaio® ensures reliable revision processes.

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.

Document Lifecycle Monitoring

Securely guide information and processes through the company

During its lifecycle, a document undergoes a series of steps and procedures: It is created, checked, approved, distributed, revised, archived, and, if necessary, deleted at some point in the future. With enaio® you are well equipped to carry out these process steps and monitor them with ease. The documents are managed exclusively in electronic format.

enaio® delivers all basic functions to implement and automate every single step of this cycle. The entire lifecycle meets legal requirements and company guidelines; in other words, it is fully compliant. The solution:

  • Digitally maps the document lifecycle
  • Ensures compliant document flows
  • Provides up-to-date, valid documents and templates anywhere in the organization
  • Monitors and secures deadlines for revision, validity, etc.
  • Provides an integrated role model for access rights

Digitally Safeguard and Document Processes

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.

Reliable Document Archiving with enaio®

Compliant (long-term) document archiving and management of document flows is indispensable in light of government audits. Paper-based document processes offer little control and security. With enaio® documents are archived in PDF/A format in an audit-proof manner after they have passed through all relevant workflow steps. The solution also ensures that legally prescribed retention periods are observed. For example, GxP-relevant data is generally stored for 10 to 15 years. After the retention period has expired, the document can be deleted automatically.

As regards archiving, even invalid versions of a document are stored in a compliant manner, including logged accesses. Audit-proof documentation optimizes all business-relevant processes. Detailed change tracking is also part of the package. It is handled via records management over the entire lifecycle of important documents.

  • Audit-proof archiving of documents and processes
  • Observe retention periods & destruction deadlines with ease
  • Detailed document history and sophisticated version management
  • Easy connection of archives, interfaces, and submission tools

Our reference:

SOP MGMT at MEDAC Gesellschaft für klinische Spezialpräparate mbH

To the reference
  • 1,000 employees
  • 50 specialist products
  • 6 countries
  • Company history reaching back more than 40 years

  • “enaio® allows our employees to find, manage, and archive information more quickly and securely – whenever, wherever, and in whatever format required. Moreover, small adjustments can be made flexibly without the need for new installations or specialist knowledge.”

    Bernd Jäkle
    Head of IT
    Engeser GmbH
  • “We chose OPTIMAL SYSTEMS because it integrates archiving, document management, and workflows into a single product.”

    Stefan Antholzer
    Head of IT
    Flottweg GmbH