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AI-Powered Quality, Compliance & GxP Automation for Pharma

Pharmaceutical organizations face constant pressure to maintain compliance with GxP, FDA 21 CFR Part 11, EU GMP Annex 11, and ICH Q10 while accelerating innovation and protecting patient safety.
Manual document control and disconnected systems can no longer keep up with the pace of regulatory change, global manufacturing, and digital transformation.
Interfacing’s AI-powered Quality Management System (QMS) helps pharmaceutical manufacturers unify processes, documentation, and compliance across the product lifecycle, from research and development to post-market vigilance.
In today’s hyper-connected economy, technology and media organizations must continuously adapt, integrating new tools, updating policies, and ensuring uninterrupted service delivery.
Manual governance processes and fragmented systems often lead to duplication, shadow IT, and non-compliance with frameworks like ISO 27001, GDPR, and SOC 2.
To maintain control at scale, enterprises need a single source of truth that aligns strategy, processes, and security controls, powered by AI for visibility and continuous improvement.

Proven GxP Compliance: Digitally enforce 21 CFR Part 11, Annex 11, and ICH Q10 requirements.
End-to-End Traceability: Link every record, SOP, and CAPA to its related process and regulation.
AI-Powered Insight: Detect non-conformities, automate CAPA, and forecast recurring issues.
Digital Twin of the Organization (DTO): Visualize the full pharma value chain for smarter quality decisions.
Validated Environment: 21 CFR Part 11 / Annex 11–ready — audit trail, electronic signature, and version control.
Request a personalized demo of the AI-Integrated Management System (IMS) to see how global pharma leaders modernize their quality and compliance frameworks.
With Interfacing’s integrated platform, you can:
Manage deviations, CAPA, and change control through automated workflows.
Digitize training management to ensure employee readiness and procedural adherence.
Simplify supplier qualification and audit readiness across your global network.
Ensure real-time visibility with compliance dashboards and KPIs.
Explore related resources:
→ FDA 21 CFR Part 820 Compliance
→ ISO 13485 Compliance Guide
→ GxP Risk Management & Compliance

Interfacing supports global pharma companies with:
Unified document, process, and risk management
AI-based process discovery for continuous improvement
Integrated quality event and CAPA lifecycle tracking
Secure, validated e-signature and access control
Multi-site, multi-language collaboration for regulated operations
Learn more about the AI-Integrated Management System or schedule a demo with our compliance experts.

Interfacing’s Enterprise Process Center® (EPC) allows you to define, document, and enforce ISO 9001 quality controls organization-wide. Policies, procedures, and SOPs are directly tied to processes and roles—ensuring your QMS is embedded in everyday operations with full transparency. .

Standardizing documentation and workflows within EPC removes the need for spreadsheets and disconnected systems. Our AI flags outdated procedures, suggests process improvements, and helps maintain version control—reducing the risk of non-compliance and audit issues.

EPC provides real-time traceability across all quality processes—from document approvals to CAPA workflows. With automated audit trails and visual process maps, you’re always ready for certification audits and internal reviews, no last-minute scrambling required

Interfacing’s QMS automates routine tasks such as change control, training sign-offs, and document updates. This not only frees up valuable staff time, but also ensures consistent adherence to ISO 9001 guidelines across all departments and geographies.

With centralized process governance and AI-enhanced workflows, EPC reduces the overhead of maintaining your QMS. From smarter audit prep to fewer non-conformities, organizations save time, cut errors, and accelerate their path to ISO 9001 certification.

ISO 9001 is about more than passing audits—it’s about evolving your organization. Interfacing’s platform helps identify quality gaps, track corrective actions, and promote ongoing learning and accountability—turning compliance into a competitive advantage.
Con más de dos décadas de experiencia en software de IA, Calidad, Procesos y Cumplimiento, Interfacing sigue siendo líder en el sector. Hasta la fecha, ha prestado servicio a más de 500 empresas de talla mundial y consultoras de gestión de todas las industrias y sectores. Seguimos ofreciendo soluciones digitales, en la nube y de IA que permiten a las organizaciones mejorar, controlar y agilizar sus procesos, al tiempo que alivian la carga de los programas de cumplimiento normativo y gestión de la calidad.
Para obtener más información o hablar sobre cómo Interfacing puede ayudar a su organización, rellene el siguiente formulario.

• Obtenga información integral en tiempo real sobre sus operaciones.
• Mejore la gobernanza, eficiencia y cumplimiento.
• Garantice la alineación fluida con los estándares regulatorios.

• Simplifique la gestión de calidad con flujos de trabajo automatizados y monitoreo..
• Optimice CAPA, auditorías de proveedores, capacitaciones y flujos relacionados..
• Transforme la documentación en información procesable para Calidad 4.0.
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• Cree aplicaciones personalizadas y escalables de forma ágil.
• Reduzca el tiempo y costo de desarrollo.
• Adáptese rápidamente y manténgase ágil frente a las necesidades cambiantes de clientes y negocios.

Las herramientas impulsadas por IA están diseñadas para optimizar operaciones, mejorar el cumplimiento y fomentar el crecimiento sostenible. Descubra cómo la IA puede:
• Responder a las consultas de los empleados.
• Transformar videos en procesos.
• Formular recomendaciones sobre el impacto de la regulación y la mejora de los procesos
• Generar formularios electrónicos, procesos, riesgos, regulaciones, KPIs y mucho más.
• Desglosar estándares regulatorios en requisitos desagregados.

Document, analyze, improve, digitize and monitor your business processes, risks, regulatory requirements and performance indicators within Interfacing’s Digital Twin integrated management system the Enterprise Process Center®!
Más de 400+ empresas y consultoras de gestión de talla mundial













































Más de 400+ empresas y consultoras de gestión de talla mundial



