Quartica MARS Platform

The unified AI platform for medical writing, safety automation, and regulatory compliance.

Safety/Pharmacovigilance Suite

AI automation for PBRER, DSUR, RMP, aRMM, PSMF, PVA, and more.

Clinical Medical Writing Suite

AI medical writing for Protocols, ICFs, CSRs, SAPs, Subject Narratives, Patient Profiles, and more.

Regulatory Affairs Suite

AI automation for CTD, CMC, Ad/Promo documentation, and more.

Manufacturing/Quality Suite

AI automation for APQR, Batch Records, Validation Protocols, CoA, and more.

About Us

Learn about Quartica’s mission, leadership, and AI innovation in life sciences.

Validation Services

Full portfolio of validation services implemented as individual activities or turn-key services

Project Management and Delivery

• Project Planning

• Cost-Benefit Analysis

• Change Management

• Validation Strategy

• Subject Matter Expertise

Technical Support

• UAT Testing

• Protocol Execution

• Report Generation

• Documentation Support

Development and Support of Computer System Validation Deliverables

• Validation Master Plan (VMP)

• System risk assessment report

• User requirements specification

• System configuration specification

• System Application Form (SAF)

• Part 11 Gap Assessment Form (GAF)

• System Assessment Checklist (SAC)

• Effectiveness Check Form and Report (ECR)

• Change Control Request for Remediation or Validation (CCR)

• Validation Test plan

• Validation Protocols – IQ, OQ, PQ

• Requirements Traceability Matrix (RTM)

• Quality assurance review

• Validation summary report

• Standard Operating Procedures (SOPs)

• Others

Business Process Consulting

Technology Support Services

Services tailored to meet the needs for big or small, well defined or development needs

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