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Free assessment26 questions · about 8 minutes

How ready are your computerised systems for Part 11 and Annex 11?

Twenty-six questions on validation, access, audit trails, electronic signatures, backup and continuity — each with its 21 CFR Part 11 or EU GMP Annex 11 reference.

  • Clause references on every question
  • Instant score on screen
  • Full report by email
Start the assessment The Part 11 guide

Self-assessment

Part 11 & Annex 11 readiness check.

Answer for your main GMP computerised system — or for your paper-and-spreadsheet process if you have no system yet.

Validation & suppliers
Are your GMP computerised systems validated for their intended use, based on a documented risk assessment?

21 CFR 11.10(a); Annex 11 §1, §4

Do you keep an up-to-date inventory of GMP computerised systems and their GxP impact?

Annex 11 §4.3

Are software suppliers and service providers (including cloud hosting) assessed, with written agreements?

Annex 11 §3

Are changes to systems made under change control, with their validation impact assessed?

21 CFR 11.10(k); Annex 11 §10

Do you periodically evaluate each system to confirm it remains in a validated state?

Annex 11 §11

Access & security
Does every user have a unique login, with no shared or generic accounts?

21 CFR 11.10(d), 11.100(a), 11.300(a); Annex 11 §12

Are access rights role-based, and reviewed at planned intervals?

21 CFR 11.10(d), (g); Annex 11 §12.1

Are password rules enforced, and are accounts locked after repeated failed attempts?

21 CFR 11.300(b), (d)

Does the system enforce the right sequence of steps and check that only authorised people perform each one?

21 CFR 11.10(f), (g)

Audit trail & data
Is there a secure, computer-generated, time-stamped audit trail of every create, change and delete?

21 CFR 11.10(e); Annex 11 §9

Does the audit trail capture the reason for GMP-relevant changes?

Annex 11 §9

Are audit trails reviewed regularly, as part of record review?

Annex 11 §9; MHRA GxP data integrity guidance

Are critical manually entered data checked for accuracy — by a second person or by the system?

Annex 11 §6

Are data transferred from instruments or other systems with built-in checks?

Annex 11 §5

Can you give an inspector accurate, complete copies of records, both readable and electronic?

21 CFR 11.10(b); Annex 11 §8

Electronic signatures
Do electronic signatures show the signer’s printed name, the date and time, and the meaning of the signature?

21 CFR 11.50

Are electronic signatures permanently linked to the records they sign?

21 CFR 11.70; Annex 11 §14

Do electronic signatures use two distinct components, such as a user ID and a password?

21 CFR 11.200(a)

If you supply the US, have you certified to the FDA that your electronic signatures are legally binding?

21 CFR 11.100(c)

Records, backup & continuity
Are electronic records protected and retrievable for their whole retention period?

21 CFR 11.10(c); Annex 11 §7.1, §17

Are backups made regularly, and have you tested restoring them?

Annex 11 §7.2

Do you have a business continuity plan for when a system is unavailable?

Annex 11 §16

Are system incidents and errors reported, assessed and followed up?

Annex 11 §13

People & procedures
Are users trained on the system before using it, with training recorded?

21 CFR 11.10(i); Annex 11 §2

Do written policies hold people accountable for actions taken under their electronic signatures?

21 CFR 11.10(j)

Is batch certification in the system restricted to authorised people?

Annex 11 §15

Get the full report by email

Every gap, the regulation it relates to, what good looks like and where Swat iQua Suite is designed to help — ready to share with your team.

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FAQ

Frequently asked questions

Can’t find your answer? Talk to our team — we reply within one business day.

Do Part 11 and Annex 11 say the same thing?

They overlap heavily — validation, audit trails, access control and electronic signatures — but Annex 11 adds risk management across the lifecycle, supplier management, periodic evaluation, incident management and business continuity. Manufacturers supplying both the US and Europe usually design for both.

Should I answer for a system or for paper?

Answer for your main GMP computerised system. If you have none yet, answer for your current paper-and-spreadsheet process — the gaps show what a system needs to cover.

Is the score an official compliance rating?

No. It is a self-assessment to help you prioritise, not an audit, a certification or regulatory advice.

Can software make us Part 11 compliant?

No software makes a company compliant on its own. Swat iQua Suite is designed to support Part 11 and Annex 11 with its technical controls; procedures, validation and the FDA certification letter remain your responsibility.

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