Quality Assurance & Regulatory Compliance Checklist

Manufacturing facilities face complex regulatory requirements from multiple federal agencies. This Quality Assurance & Regulatory Compliance Checklist helps production managers, quality control teams, and compliance officers systematically verify that their operations meet FDA, EPA, and OSHA standards while maintaining comprehensive documentation for audit readiness.

Whether you're preparing for an upcoming inspection, conducting routine internal audits, or establishing baseline compliance protocols, this template ensures nothing falls through the cracks. The structured format covers facility operations, employee training records, safety protocols, environmental controls, and quality management systems—all critical components that regulators scrutinize during inspections.

Paperform makes regulatory compliance more manageable by digitizing your checklist processes. Instead of juggling paper forms and spreadsheets, you can capture inspection data, upload supporting documentation, and track compliance status in real-time. Conditional logic ensures inspectors only see relevant questions based on your facility type and regulatory scope, while file upload fields let you attach certificates, training records, and corrective action reports directly to each submission.

For manufacturing operations managing multiple facilities or shift schedules, Stepper (stepper.io) can automate your compliance workflows. Route checklist submissions to quality managers for review, trigger corrective action requests when non-compliance is detected, send alerts to training coordinators when certifications are expiring, and automatically update your quality management system. This ensures compliance issues are addressed promptly and systematically.

When audit findings require formal documentation or corrective action plans, Papersign (papersign.com) lets you convert submissions into compliance agreements or corrective action acknowledgments that employees and contractors can sign electronically, creating a complete audit trail that satisfies regulatory requirements.

This template is specifically designed for quality assurance managers, production supervisors, EHS coordinators, and compliance officers in pharmaceutical manufacturing, food processing, chemical production, medical device manufacturing, and other FDA, EPA, or OSHA-regulated facilities.