Optimize Your Biotech Operations with Advanced Change Management Software

Automated Validation Ready Change Control

Automate the end to end change control lifecycle from initial proposal to post implementation review. Built in routing rules automatically dispatch changes to the correct Subject Matter Experts (SMEs) based on product line, facility, or impact level. By streamlining approvals, CQ eliminates manual bottlenecks, drastically reducing cycle times for critical process modifications.

FDA Audit Readiness and 21 CFR Part 11 Architecture

Defend your quality workflows during any unannounced FDA inspection. The software features fully compliant 21 CFR Part 11 and EU Annex 11 electronic signatures, closed loop CAPA linking, and an unalterable, time stamped audit trail. It captures the who, what, when, and why of every system modification, turning stressful audit prep into a continuous state of readiness.

AI Driven Impact Assessments

Leverage advanced platform intelligence to embed predictive risk scoring directly into your change workflows. Utilize automated Failure Modes and Effects Analysis (FMEA) templates to instantly flag recurring findings and evaluate how a proposed change affects Critical Process Parameters (CPPs) before triggering cross functional sign offs.

Quality Assurance Guardrails and Master Record Sync

Enforce rigid pre-approval and post implementation efficacy checks. The platform prevents a change control record from closing until all dependent action items—such as updating Master Batch Records (MBRs), updating Standard Operating Procedures (SOPs), and completing employee re-training—are fully verified by Quality Assurance.

Enterprise Tech Stack Interoperability

Connect your entire quality ecosystem without costly IT overhead. Backed by open access REST APIs, CQ integrates seamlessly with core biotech systems including Laboratory Information Management Systems (LIMS), Manufacturing Execution Systems (MES), and Enterprise Resource Planning (ERP) platforms like SAP or Oracle.

Real Time Compliance Analytics and Executive Dashboards

Monitor the health of your site operations at a glance. Generate instant reports on change cycle times, open deviations, regulatory submission triggers, and upcoming implementation deadlines to support Management Reviews and data driven decision making.

Native Salesforce User Experience

Minimize training overhead with an interface designed for the modern life sciences workforce. Via an intuitive, streamlined interface, cleanroom operators, lab technicians, and remote executives can track open tasks, sign off on pending approvals, and access required training from any authorized device.

Configurable Workflows for Multi Site Scale Up

Tailor change workflows to match your exact Standard Operating Procedures without writing custom code. Easily adapt processes to support multi site tech transfers, contract manufacturing organization (CMO) collaboration, or the distinct transition from clinical phases to commercial launch.

ALCOA+ Secure Data Integrity

Protect your proprietary molecule data and manufacturing secrets. Leveraging native Salesforce Shield and Data Mask technologies, our security framework ensures all records are Attributable, Legible, Contemporaneous, Original, and Accurate (ALCOA+) while providing advanced encryption and Multi Factor Authentication (MFA).

GAMP 5 Software Validation and Onboarding Support

Partner with a US based support team that speaks your language. Our customer success engineers possess deep expertise in computer systems validation (CSV) and GAMP 5 lifecycles, ensuring your software updates are smooth, automated, and fully compliant with the latest industry standards.