Data integrity, as set out in MHRA guidance, means the data your regulated activities rely on must be Attributable, Legible, Contemporaneous, Original and Accurate, and also complete, consistent, enduring and available. That’s the ALCOA+ principle. In IT terms, you meet it through controlled user access, reliable audit trails, accurate system time, proper change control, and backups that keep records readable for as long as they must be retained.
For a pharmaceutical business, good data integrity isn’t just good practice, it’s what inspectors look for and what keeps your products and records trustworthy. Here is what each principle means for your systems.
Attributable and contemporaneous
Every record needs to show who did what and when. That means individual user accounts (never shared logins), multi-factor authentication, and systems with reliable audit trails and an accurate, protected clock, so the record of an action is trustworthy and made at the time.
Legible, original and accurate
Records must stay readable, in their original form, and correct. Your systems should prevent unauthorised changes, capture any change with a reason and an audit trail, and keep the original data, not just a summary. Controls that make tampering hard, and visible, sit at the heart of this.
Complete, consistent, enduring and available
The plus in ALCOA+ asks that records are whole, in a sensible order, retained for as long as required, and retrievable when needed. Encrypted, tested backups, a clear retention approach, and systems that keep data accessible and readable over time are how you deliver this.
How the right IT partner helps
A provider who understands regulated environments helps you configure access, audit trails and backups to support data integrity, keeps the supporting documentation current, and has it ready when an inspector asks. The aim is for good data integrity to be the natural result of how your systems are set up, not something staff have to work around.
A real example: systems built to last
We were closely involved in developing the business systems that helped a client grow from 20 users to 100 over five years. Well-built, well-documented systems are exactly the foundation that makes data integrity achievable and sustainable as a business grows.
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 data integrity review
Want to be confident your systems support data integrity? Book a free IT and cyber security review with First Stop IT and we’ll assess your controls against what the MHRA expects.