The enaio® Enterprise Content Management software by OPTIMAL SYSTEMS complies with the policies and legal requirements that relate to the use of electronic archiving techniques as part of proper accounting procedures. In addition, it covers specific requirements from regulated environments, especially in the pharmaceutical sector. This is the result of a test conducted by a Certified Information Systems Auditor (CISA).

Companies that store commercial documents electronically must comply with numerous requirements, including the German Commercial Code, the German Tax Code, the German Federal Data Protection Act/Digital Signature Act, and the Principles for Proper Management and Storage of Books, Records, and Documents in Electronic Form, and for Data Access. This includes:

  • Obligation to ensure that data can be made available immediately
  • Ensuring the machine evaluability of originally digital data
  • Creating new access rights for the tax authority in the context of an external audit
  • Storing document versions (original and converted version if applicable)
  • Implementing the rights to rectification, blocking or deletion of personal data
  • Support for special features in the document process, e.g. via qualified signatures

enaio® version 8.1 can fulfill these requirements in accordance with the declaration of conformity. In addition, another result of the audit demonstrates that the ECM solution covers regulatory requirements and guidelines, such as the FDA’s Guidance for Industry Part 11 (CFR), the Good Clinical Practices (GCP), and the Good Automated Manufacturing Practice (GAMP®5).

“This Declaration of Conformity gives our customers the reassurance that enaio® provides them with a reliable basis for complying with the current regulations for storing electronic documents, even in regulated environments such as the pharmaceutical industry ,” explains Sven Kaiser, Head of Marketing at OPTIMAL SYSTEMS.

The audit was conducted on the basis of the statement of the German Institute for Accountants (IDW) on accounting “Principles of proper accounting when electronic archiving procedures are used” and for the areas of documentation and development in accordance with IDW PS 880 (Standard for the creation of software certificates).