Manage, control and sign SOPs in accordance with GMP

Simple, safe, time and cost saving

The manual management of Standard Operating Procedures (SOPs) and accompanying documents presents companies with major challenges. Monitoring deadlines, validity and ensuring document availability is becoming a serious problem as revision and distribution cycles become shorter and shorter and document volumes increase. XERI is the ideal platform for the electronic management of SOP documents. It maps the entire SOP lifecycle as a customizable workflow and fully meets the requirements for long-term archiving, electronic signature and audit trail. Working with XERI thus ensures that the same process flows are always maintained and that they are documented in an audit-proof manner.

Your benefits:

  • Full control of the document lifecycle
  • Traceability of decisions or adjustments due to complete logging of all accesses
  • Automatic calculation, monitoring and updating of deadlines
  • Security that users always access current valid document versions
  • Automatic invalidation of invalid documents
  • Reduction of time and personnel expenditure
  • Reliable and resilient compliance with the requirements of CFR21 Part 11, GxP and the Signature Act
  • Complete version and change history (audit trail) in the form of an eRecord (Who? What? Why?)


Document Management Software

Get familiar with XERI, the secure and efficient document management solution for your organization. As a powerful and modern DMS solution, XERI is perfectly aligned with the processes of the pharmaceutical industry, biotechnology, medical technology, chemistry, cosmetics and food industry as well as other highly regulated industries.

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Compliance with GMP requirements

  • Authorization concept with predefined roles, profiles, user groups and authorizations to implement the highest security requirements
  • Review, invalidation and archiving of documents
  • Controlled printing and authorized paper copies
  • Documents handed out to external persons can be traced under version control
  • Up-to-date overview of status and revision dates of all SOPs including annexes and appendices (forms, checklists)
  • Traceable distribution (assignment of SOPs to affected employees)
  • Target group-oriented information distribution for new or modified documents (via e-mail or XERI notification system)
  • Flexible assignment of dates between release and validation to provide a training period
  • Live search, tagging, storable search filters for targeted access to the right document
  • Creation of graphical entry pages
  • Consulting services for the introduction and validation of the software
  • Electronic password security

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Systematic document control

Does your company have to meet high standards? The document management system XERI provides an efficient solution based on highest security, from the electronic signature to the system-wide audit trail. Compliance with normative requirements as well as legal regulations is ensured holistically and documented in a comprehensible manner at all times. With XERI you have the right answers to the auditor's questions about your documentation.

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