Pharmaceutical guides

Annex 11 explained

What Annex 11 expects from computerised systems, and what that means for your ERP.

Get in touch

What Annex 11 is

Annex 11 is part of the EU guidelines on Good Manufacturing Practice. It sets out expectations for computerised systems used in GMP-regulated activities. The MHRA applies the same GMP guidance in the UK.

It covers the full life cycle of a system: risk management, supplier oversight, validation, data integrity, audit trails, security, change control and business continuity.

For an ERP, Annex 11 applies to the functions that create or manage GMP records, such as lot tracking, quality status and batch-related data.

Key Annex 11 requirements

The areas most relevant to an ERP.

Risk management

Controls proportionate to the risk to quality and patients.

Suppliers and service providers

Formal agreements and oversight of suppliers.

Validation

Documented evidence the system is fit for purpose.

Audit trails

Records of GMP-relevant changes and deletions.

Change control

Changes assessed, approved and documented.

Continuity and backup

Data protected and recoverable.

Useful next reads

Try Business Central in an environment built around your business

Most trials drop you into a generic demo company that looks nothing like the way you actually work. Ours doesn't. We configure your free trial around your business and the use case you care about, so you and your team can test real scenarios with data and processes you recognise.

It starts with a short questionnaire about your industry, your current systems and what you want to prove out. Once that's back with us, your tailored trial can usually be made available within a few working days. Prefer a guided walkthrough first? A standard demo is still on the table - just tell us which you'd like.

Book a standard demoMake a general enquiry
01

Tell us about your business

Complete a short questionnaire covering your industry, processes and the things you most want to test.

02

We configure your trial

We set up a Business Central environment around your use case, so you're not clicking through a generic demo company.

03

You're up and running in days

Your tailored trial is typically ready within a few working days of the questionnaire coming back to us.

Enquiry form

Get in touch

Tell us about your GMP processes and we'll talk through how a Business Central project could support Annex 11 expectations.

TD SYNNEX and its elite Dynamics partner network need the contact information you provide to us to contact you about our products and services. You may unsubscribe from these communications at any time. For information on how to unsubscribe, as well as our privacy practices and commitment to protecting your privacy, please review our Privacy Policy.

FAQ

Frequently asked questions

Part of the EU GMP guidelines covering computerised systems used in GMP-regulated activities.

The MHRA applies the same GMP guidance, including Annex 11, in the UK.

Annex 11 is EU GMP guidance; 21 CFR Part 11 is a US FDA regulation on electronic records and signatures. They overlap but differ in detail.

No software is compliant on its own. Business Central provides audit trail and access controls, and compliance depends on how it is configured, validated and governed.

Pharmaceutical and life sciences ERP