OneXPro

This digital solution transforms manual change control processes into efficient, electronically managed workflows by automating the initiation, review, approval, and closure steps within regulated industries such as pharmaceutical, engineering, and manufacturing sectors. Its main features include secure electronic signatures, extensive audit trails with hash-chained and append-only records, configurable workflows with role-based access controls, and full compliance with stringent standards like 21 CFR Part 11, EU GMP Annex 11, and GxP guidelines, ensuring data integrity and traceability. It addresses challenges related to paper-based documentation, reduces risk of manual errors, streamlines regulatory compliance, enhances data security, and facilitates seamless validation and audit readiness for professionals managing quality, change control, and documentation processes.

OneXPro può essere trovato in Document Management & eSignature Tools categorie.