For Life Sciences companies, it’s important to stay on top of regulatory compliance and ensure the highest standards.
A Mock Inspection is a valuable tool to assess their readiness for an actual inspection and identify areas for improvement.
Some of the benefits of a mock inspection include:
- Identifying areas for improvement before an actual inspection
- Assessing the effectiveness of quality assurance processes
- Identifying gaps in compliance with regulatory requirements
- Improving staff understanding of regulatory requirements
- Boosting staff confidence in handling actual inspections
- Improving patient care and outcomes
Investing in a regulatory mock inspection demonstrates a serious commitment to patient safety, data integrity, and regulatory compliance.
Mock Inspection: How to proceed in the right direction?
Our Quality Assurance experts are very pleased to share with you some tips:
1) Put the right people in the right roles
Select a QA mock facilitator who has the appropriate experience and skill set. This is usually a QA professional with solid, proven esperience in the regulatory focus area (e.g. GCP, PV, GMP), including inspection and auditing experience.
2) Appropriately prepare your team and documentation
Companies create any number of strategies to ensure inspection readiness. Many provide direct inspection-readiness training for management and other kei SMEs. This includes classroom training on the inspection process, mock interviews, SOP refreher training, and communication tips.
3) Follow the industry standard inspection process
Regulatory develops their own inspection style, yet there are common expectations across the board. Have a presentation ready includes high-level information on: company background, clinical development process and status, electronic systems used, the quality system and QA organization, vendors and inspection history.
How can the Arithmos team support you?
Arithmos provides inspection preparation training, mock interviews and GxP mock inspections to identify any potential findings from a regulatory inspection.
We also support your internal team with any remediation and training.
Our QA team has extensive experience preparing for, participating in, managing and hosting MHRA, FDA and EMA inspections.
We are Business and Technology experts in the Life Sciences industry.
We are a long-standing Partner and Service Provider across Clinical Development, Regulatory and Compliance, Quality Management, Pharmacovigilance, and Medical Affairs domains.
We help pharmaceutical, biotechnology, nutraceutical, medical device, universities, hospitals and non-profit organisations to gain the best business value through technology-enabled solutions and achieve excellence in business operations.