Azumuta supports pharma and life science companies by digitizing checklists, audits and logbooks for every batch production. Every step gets recorded, checked and double checked, and kept for as long as your retention policy requires.
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Your entire batch production is digitized, while everything around it still runs on paper. Nobody notices an error or a missed value until it comes up in a review.
Does this sound familiar?
It runs in the browser or as an app, and it keeps working when your network drops. Records sync once the connection is back. Approved instructions can be exported automatically, so your business continuity plan always has a current copy. It can run on your own infrastructure.
Your operators work from the version QA approved, in their own language. Changes go through the author, approver and QA sign-off you configure before they reach the floor, and every revision is kept. While a checklist is in approval it stays locked. The person who wrote it cannot approve it alone.
Each value is checked the moment it is entered. A value outside its limits is recorded as a non-conformity, and the step stays open. The step can also calculate the next quantity from the weight just entered, so the correction happens on the line.
Each step is recorded under that person's own account. They re-authenticate with your SSO or password. A signature is added when your procedure asks for one, including a second approval. Only people with the right role and training can execute the step.
Every login, execution and change is logged with who, what and when, in the order it happened. During your retention period, nobody can edit or delete an entry. A correction is a new line. When the period ends, the record is removed under your own policy.
Checklists, audits and logbooks sit in one place. At handover, the next shift sees what the last one left open. "Was the 6pm cleaning done?" is answered on screen. Need a record in another system? Export it to PDF.
Whatever system you choose, hold it to this standard.
Your MES runs the batch. Checklists, audits and logbooks sit beside it. This does not replace your MES, your ERP or your PLM.
You get the controls that 21 CFR Part 11 and EU GMP Annex 11 ask for: personal accounts, electronic signatures, version control and an audit trail. During your retention period, that trail cannot be edited. Compliance itself comes from validating the system for your intended use. Your QA team knows how to validate. Each release comes with the documentation to support that.
Every change to a validated system means revalidation. So you choose which releases to take, and when.
A top-5 pharma company runs the GMP paperwork around the batch as digital checklists, from cleaning rounds to the shift logs.
At a large sterile manufacturing site in Europe, a top-5 pharma company uses one platform for GMP work on the line and safety-critical maintenance.
Azumuta gives you the controls Part 11 asks for. You demonstrate compliance by validating the system for your intended use.
You validate it, for your own intended use. Every GMP release comes with documentation to support that.
Only the releases you take. You choose when to upgrade, within the supported window.
No. Your MES keeps the batch. Checklists, audits and logbooks sit beside it. It does not replace your MES, your ERP or your PLM.
Yes. It can run on your own infrastructure.
Operators keep working offline, even in the browser. Records sync when the connection is back.
No. Approval is a workflow you configure. The person who did the work cannot approve it alone, and the record shows who approved it.
Yes. A Quality Agreement covers how the product is developed and released.
No. Most sites start standalone.
Yes, as PDF exports.
Personal accounts with SSO, badge or password, and re-authentication when they sign. No shared logins.
Only users with the right role and qualification.
Bring a checklist, audit or logbook you know well, like a cleaning log or a line clearance. You leave with the record it would leave.