Professional reviewing GMP documentation and audit trail on screen

Products for regulated environments

Our own tools, built with open-source technology and no licence fees, for two jobs that in many organisations still live in folders and spreadsheets: GMP quality and ENS documentation.

Two products, one approach

Electronic signature, audit trail, frozen versions and auditor exports. Rolled out module by module, on your server or in our cloud.

Annexa

GMP quality management software

Documents, training, deviations, equipment and change control on one platform with electronic signatures and a full audit trail, designed in line with EU GMP Annex 11.

  • Complete document lifecycle, from draft to obsolete
  • Mandatory reading by role and by version
  • Electronic signature with Microsoft 365 and a personal PIN

For advanced therapy units, hospital pharmacy, QC laboratories and pharmaceutical SMEs.

ENS Docs

ENS documentation and evidence

Policies, procedures, appointments and records for Spain's National Security Framework (ENS), with versions, management and staff signatures, periodic tasks and an audit evidence pack.

  • 38 ENS inventory documents preloaded
  • Acceptance campaigns with automatic reminders
  • Auditor export with a SHA-256 manifest

For ICT suppliers to the public health system and organisations of 10 to 250 people.

What they have in common

Evidence from day one

Every action is recorded with user, date and version.

Exportable data

Excel or CSV listings and audit packs.

No licence fees

Open-source technology, deployed wherever you need it.

Supported roll-out

Configuration, migration, training and support.

See it with your own processes

In a 30-minute demo we show you the product with sample data and discuss how it fits your organisation.

Book a demo