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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.
With over two decades of AI, Quality, Process, and Compliance software expertise, Interfacing continues to be a leader in the industry. To-date, it has served over 500+ world-class enterprises and management consulting firms from all industries and sectors. We continue to provide digital, cloud & AI solutions that enable organizations to enhance, control and streamline their processes while easing the burden of regulatory compliance and quality management programs.
To explore further or discuss how Interfacing can assist your organization, please complete the form below.

• Gain real-time, comprehensive insights into your operations.
• Improve governance, efficiency, and compliance.
• Ensure seamless alignment with regulatory standards.

• Simplify quality management with automated workflows and monitoring.
• Streamline CAPA, supplier audits, training and related workflows.
• Turn documentation into actionable insights for Quality 4.0

• Build custom, scalable applications swiftly
• Reducing development time and cost
• Adapt faster and stay agile in the face of
evolving customer and business needs.
The AI-powered tools are designed to streamline operations, enhance compliance, and drive sustainable growth. Check out how AI can:
• Respond to employee inquiries
• Transform videos into processes
• Assess regulatory impact & process improvements
• Generate forms, processes, risks, regulations, KPIs & more
• Parse regulatory standards into requirements

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®!
More than 400+ world-class enterprises and management consulting firms































