GMP-compliant cleaning documentation for pharma and labs

For non-classified areas: labs without cleanroom classification, technical and storage areas, corridors, offices and break rooms. Classified cleanrooms (grades A to D) and product-contact processes stay with your validated GxP systems.

Yes. At a pharmaceutical company, LiteLog passed the quality assurance review, the validation and the approval by internal IT. How the process looks for you depends on where you use it. We are happy to visit and walk your team through the procedure.

Yes, in non-classified areas. LiteLog documents according to the GMP data integrity requirements (ALCOA+): every entry is attributed to a person, time and area, the server assigns the timestamp, corrections create new entries with a reason, and the original is preserved. At one pharmaceutical company LiteLog passed the reviews by QA, validation and IT. Classified cleanrooms remain with your validated GxP systems.

We do not issue a general declaration of conformity for Part 11. The digital signature is available as an add-on: it is built on the model of Part 11 and applies when submitting reports and forms, completing tasks, finishing a tour and approving change-control requests.

Each cleaning type is its own task at the area, with its own checklist and its own recurrence: daily, on specific weekdays, weekly, monthly or yearly. At the area, your team only sees what is due today.

The original is kept and the correction is created as a new entry. For time entries, a reason for change is mandatory. With change control switched on, a correction only takes effect once a second authorized person approves it.

You export the history as a PDF, filtered by building, area and period. It shows who did which cleaning, where and when, with checklist and photos.

Yes. The app stores scans, tasks, forms and reports on the device. As soon as a connection is back, it syncs everything automatically. Entries that arrive late are not lost.

Yes. A cleaning company gets its own access to the portal and the app. It creates its employees itself and sees only its own accounts. Their records come to you just like those of your own team.

All data is stored on servers in Frankfurt am Main, including backups. You can sign a data processing agreement (DPA) with us.

Yes, through their own customer access. You decide what your client sees, always limited to their site. Reports can also be emailed to them automatically.

We provide information on features, hosting and security as well as the data processing agreement. For the digital signature, you receive the technical description. Contact us through the contact form.

Who, when, what, old and new value, and the reason. Who: name, login name and role; for completions and signatures also the personnel number. When: settings, access events and account changes carry the server time with seconds, in local time and in UTC. For signatures, device time and the server's time of receipt stand side by side, so it stays visible when a device was offline. For completions, the phone's clock applies if it is at most one hour behind the server time and at most five minutes ahead of it. Otherwise the server time counts. What: area, record and event, for example created, changed, archived or cancelled. One line per changed field with old and new value. The reason consists of a reason code and a text. All principles are in the manual: Audit trail principles.

Not when recording, but for every change afterwards. Creating a task, completing a task, submitting a form or creating an issue report needs no reason; who and when is recorded. A reason is mandatory for later changes, for example when an issue report or a report is corrected, for cancellation and archiving, and for "not feasible". For changes to templates, roles, schedules and site settings you switch the mandatory reason on in the settings; with change control a second administrator decides as well. The reason consists of a code and a text and is stored with the old and new value, in the portal, in the app and via the API. The full overview is in the manual: When a reason is mandatory.

That depends on the operating model. On the main platform there are 2 to 3 updates a month, each with a version number and release notes. On a dedicated server hosted by LiteLog, updates are bundled into agreed windows and checked on an acceptance environment beforehand; you set the date. On your own servers we hand over a frozen version. Updates then only come when needed, for example security fixes; larger version jumps run as a project. Updates never alter the audit trail. More in the manual: Security and privacy.