To get your IT and data ready for an MHRA inspection, make sure four things are in good shape: controlled access with reliable audit trails, sound data integrity and tested backups, validated and documented computer systems, and the ability to produce the supporting evidence quickly. Inspections go far more smoothly when this is part of how you run day to day, rather than a scramble when a date is set.
Inspectors look closely at how you manage data and systems. The good news is that the same controls that keep you compliant also keep you secure and resilient. Here is a practical checklist.
1. Access and audit trails
Make sure every user has their own account, shared logins are gone, and multi-factor authentication is in place. Confirm your regulated systems keep reliable audit trails, with an accurate, protected clock, so you can show who did what and when.
2. Data integrity and backups
Check that records are complete, accurate and protected against unauthorised change, and that your backups are encrypted, tested and able to keep records readable for the full retention period. Be ready to demonstrate a restore if asked.
3. Validation and change control
Confirm your computer systems that support regulated activities are validated for their intended use, and that changes since then have been controlled and documented. Gaps in validation and change control are a common inspection finding, so this is worth checking well ahead of time.
4. Documentation you can find fast
Policies, system inventories, validation records, access reviews and incident logs all need to be current and easy to produce. An inspection is far less stressful when the evidence is organised and at your fingertips rather than scattered across people’s inboxes.
A real example: organised, evidenced systems
We helped a client become cyber security compliant to meet a customer’s requirements and win a large tender. Being able to evidence your controls clearly is valuable in any audit or due-diligence situation, and an MHRA inspection is no different.
Why pharmaceutical businesses choose First Stop IT
First Stop IT has supported businesses since 2002 and specialises in secure, well-documented IT for organisations with compliance obligations. Our credentials include:
- Cyber Essentials Certified
- IASME Cyber Assurance (Gold)
- NCSC Assured Service Provider (Cyber Advisor for Cyber Essentials)
- Microsoft Partner
- Crown Commercial Service Supplier (G-Cloud)
- Quality Principles Certified
We look after more than 2,000 endpoints across 50 companies, we’ve been named a Top 50 UK MSP for three years running, and we support organisations with 10 to 100 employees across Essex, Hertfordshire and London, including Harlow and Bishop’s Stortford.
Book a free IT and compliance review
Inspection on the horizon? Book a free IT and cyber security review with First Stop IT and we’ll help you check your systems and evidence are ready.