SCORECARDS

R&D TRANSITION TO CLINICAL TRIAL MANUFACTURING READINESS SCORECARD

At Quality Systems Now, we know the transition from R&D to clinical manufacturing can feel uncertain. That’s why we created the Clinical Manufacturing Readiness Scorecard — a fast, practical way to uncover your gaps before they become regulatory issues.

GMP LICENSING AND ISO ACCREDITATION READINESS SCORECARD

Discover whether your facility is genuinely ready for GMP licensing or ISO accreditation. This assessment reveals compliance gaps that typically emerge during inspections. Evaluate if your QMS, processes, and documentation align with key regulatory requirements before submitting your application.

GMP PHARMACEUTICAL REGULATORY INSPECTION READINESS SCORECARD

Evaluate your facility’s quality system, validation programs, and team readiness with our 20-question PIC/S PE009-17 assessment. Identify gaps before regulators do.

ISO 13485 MEDICAL DEVICE NOTIFIED BODY INSPECTION READINESS SCORECARD

Assess your QMS today to see if it can pass ISO 13485 certification or a surveillance audit. Evaluate your documentation, design controls, risk management, and team audit confidence.

IF A REGULATOR WALKED IN TODAY,

ARE YOU PREPARED FOR AN AUDIT?

At Quality Systems Now, we understand the pressure of being audit-ready.

That’s why our Compliance Readiness Assessment is designed to

help you quickly identify any gaps in your GMP and ISO 13485 compliance.