SmartSuite for Pharmaceuticals
SmartSuite unifies quality, regulatory, clinical, manufacturing, and operational workflows—replacing disconnected pharma systems with one modern, connected platform.
Transform Quality, Regulatory & Operational Workflows
Pharmaceutical organizations often manage critical processes across disconnected systems — from quality and regulatory tools to clinical and manufacturing platforms. These silos create data gaps, slow compliance activities, and increase operational risk.
SmartSuite replaces this fragmented environment with one connected platform that unifies teams, data, and workflows across the pharma value chain.
SmartSuite helps pharmaceutical organizations:
- Integrate quality, regulatory, clinical, manufacturing, and ops workflows
- Reduce system fragmentation across QMS, RIM, and operational tools
- Standardize workflows for audits, deviations, CAPA, and documentation
- Improve coordination between quality, regulatory, clinical, and operations
- Gain real-time visibility into compliance, risks, actions, and approvals
Integrated Quality Ops
Quality • Regulatory • Clinical • Manufacturing
Unified data + connected compliance workflows
Connected Programs
QMS • RIM • CAPA • Audits
One platform replacing fragmented pharma systems
Rapid Implementation
Prebuilt pharma solutions speed adoption
No-code tools adapt quickly across teams & sites
Maintain Continuous GxP Compliance
Automate documentation and evidence tracking to meet FDA 21 CFR Part 11, EMA Annex 11, and GMP standards.
Improve Product Quality and Audit Readiness
Track deviations, perform root-cause analysis, and manage CAPAs from issue to closure with complete traceability.
Streamline Validation and Documentation Workflows
Digitize validation documentation, reviews, and approvals to ensure audit readiness and reduce manual effort.
Ensure Supplier Compliance and Accountability
Evaluate supplier quality and certification status through automated reviews and performance tracking.
Featured Solution Suites For Pharmaceuticals
Explore SmartSuite Solution Suites built to ensure compliance, quality, and operational excellence in regulated pharma environments.
Manage non-conformances, CAPAs, and inspections with full traceability from issue detection to resolution.
Ensure adherence to AS9100, ITAR, DFARS, CMMC, and aerospace regulatory mandates with structured workflows and audit-ready reporting across programs and operations.
Plan, execute, and report on audits with complete assurance oversight — linking findings to risks, controls, and remediation actions in a single connected workspace.
Standardize vendor due diligence, centralize assessments, and monitor ongoing risk exposure to ensure supplier reliability and compliance.
Why Smartsuite For Pharmaceutical Companies
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GxP-Aligned Connected Workflows
Unify quality, regulatory, and R&D operations within one platform built for GMP, GLP, and GCP environments.
Designed for FDA and EMA Compliance
Pre-built templates aligned with 21 CFR Part 11, Annex 11, and ISO 9001 ensure traceability and audit readiness.
Validated Platform with Audit Trails
Every change is logged automatically, maintaining a compliant record of activity for audits and inspections.
AI-Powered Automation
Use SmartSuite AI Assist to summarize deviations, generate CAPA reports, or draft submission documents instantly.
Aligned with Regulatory Frameworks
Map controls and evidence to the frameworks your institution follows.
- FFIEC, CRI Profile, SOX, and OCC guidelines
- NIST and ISO cybersecurity standards
- Vendor oversight and audit traceability
AI That Adapts to Your Industry — On Your Terms
SmartSuite embeds AI directly into your workflows to accelerate automation, reporting, and insight generation — while giving you complete control over which models you use and how your data is handled.
Choose from OpenAI, Anthropic, Google Gemini, AWS Bedrock, Azure, Perplexity, Nscale, IBM watsonx, and Xai. Connect your own API keys for full privacy and compliance.
- Bring Your Own AI
Accelerated first-response targets for high-severity issues, so critical incidents are acknowledged, triaged, and moving toward resolution as quickly as possible.
- AI in Action
Use AI to generate compliance reports, summarize audits, and build automations that enhance accuracy and efficiency.
- Data Privacy by Design
SmartSuite never uses customer data for model training. All AI calls route securely through your credentials.
- Customizable Intelligence
Mix models for different needs — reporting, content creation, risk analysis — and tailor performance per workflow.
A Unified Platform for People, Processes, and AI
SmartSuite unites people, data, AI, and systems on one open platform—designed to integrate with anything, secure everything, and adapt to any business process. From industry-specific workflows to enterprise integrations, SmartSuite gives every team the flexibility to work smarter together.
AI powered solutions, purpose built for any industry, delivered on a single platform.
A single platform that powers every process to become smarter, faster and more connected.
Your control tower to select, govern, and monitor any AI model used in SmartSuite—ensuring visibility, compliance, and security across every workflow.
Connect SmartSuite to any system or data source with enterprise-grade security and governance.
Featured Resources
Explore resources and insights for compliance, risk, and quality leaders in aerospace.
Frequently Asked Questions
Common questions from banks, credit unions, and fintech teams.
SmartSuite maintains full audit trails, access controls, and electronic signatures, ensuring compliance with FDA and EMA data integrity regulations.
Yes. SmartSuite provides a validated framework with documentation for IQ/OQ/PQ and supports customer-specific validation processes.
Yes. SmartSuite connects suppliers, quality events, and manufacturing sites through integrated CAPA and audit management workflows.
Most organizations deploy within 60–90 days, depending on validation scope and integration requirements.
Ready to Connect Quality, Compliance, and R&D?
See how pharmaceutical leaders use SmartSuite to ensure GxP compliance, accelerate product development, and streamline audits.