Raising the Bar in GxP Compliance – Part 13: Inspection Readiness as a Continuous Practice
Welcome to the thirteenth instalment of Raising the Bar in GxP Compliance, Rephine’s expert-led blog series for QA and regulatory professionals.
In this edition, we explore why inspection readiness can no longer be a last-minute scramble. With global regulators such as the FDA, EMA, and MHRA increasingly favouring unannounced inspections, organisations must embed compliance into everyday practice. Discover how Rephine helps companies move beyond mock audits to cultivate a continuous state of readiness—leveraging digital QMS tools, cross-functional collaboration, and a proactive quality culture to ensure audit preparedness is always on.
Regulatory inspections can happen anytime—readiness is no longer optional.
Mock audits alone won’t protect your license or reputation. Today’s compliance leaders are embedding inspection readiness into daily operations, transforming it into a continuous, company-wide discipline.
From Mock Audits to a Culture of Continuous Inspection Readiness
Achieving and maintaining a state of inspection readiness is no longer a goal limited to just a few weeks before a regulatory visit. In today’s highly regulated pharmaceutical and biotech environment, inspection readiness must evolve into a continuous, embedded practice that permeates the entire organisation.
Why Traditional Mock Audits Fall Short
Traditional mock audits play an important role in preparing teams for inspection conditions. However, they are often executed as isolated events, disconnected from the daily rhythm of the Quality Management System (QMS). To truly build a culture of readiness, organisations must move beyond episodic rehearsals and ensure compliance is part of routine operations.
This includes:
- Establishing real-time quality metrics and dashboards to identify gaps before they become findings
- Integrating training and role-based simulation into regular staff development
- Conducting targeted, risk-based internal audits throughout the year
Regulatory Focus Areas Driving Readiness Needs
The trend towards unannounced inspections, especially in the EU and US, is growing. Agencies like the EMA, FDA, and MHRA are placing increased emphasis on:
- Data integrity
- Supplier oversight
- Change control traceability
Being caught off-guard can not only lead to compliance risks, but also business disruption and reputational damage. In contrast, companies that embrace continuous readiness are more agile and capable of adapting to new regulations and inspection styles.
Building an Inspection-Ready QMS
An inspection-ready QMS is proactive, not reactive. This requires alignment across departments:
Cross-Functional Collaboration is Critical
- QA and operations must collaborate closely to ensure documentation and practices are audit-ready at all times
- IT and digitalisation teams must ensure validated systems are aligned with GxP requirements
- Senior management must actively promote quality culture and allocate resources accordingly
The Role of Digital QMS Tools
Digital QMS platforms can support this shift by:
- Automating audit trail capture and access control
- Enabling real-time monitoring of CAPA effectiveness
- Offering mobile access to SOPs and training records during inspections
How Rephine Supports Continuous Inspection Readiness
At Rephine, we help clients transition from reactive to continuous inspection readiness. Our services include:
- Development of risk-based audit programmes
- Integration of readiness checks into digital QMS workflows
- Customised training and simulation sessions
- Strategic support for regulatory inspection strategy
Dr. Eduard Cayón
CSO (Chief Scientific Officer)
About the Author:
Dr. Eduard Cayón is the Chief Scientific Officer (CSO) at Rephine, a global leader in GxP compliance and quality assurance.
We don’t just deliver audits or consultancy services — we partner with clients at every stage of their quality journey, offering end-to-end solutions that empower confidence and compliance.
With over 25 years of experience, Rephine has built an enviable reputation as the gold standard in the industry operating from four primary locations: Stevenage in the UK, Barcelona in Spain, India, and Shanghai in China.
Dr. Cayón, who holds a Ph.D. in Organic Chemistry, is a deeply experienced pharmaceutical industry consultant and auditor.
He is dedicated to supporting pharmaceutical, biotech, and medical device companies in meeting the highest standards of manufacturing and supply chain integrity.