Compliance assessment
Where your quality system stands against a standard, clause by clause, and the page in your own documents behind every answer.
21 CFR 4 · 210 · 211 · ISO 13485Inside the moduleSelf-assessment
Your library read against the rules it sets itself, and every place two of your own documents require different things.
YOUR OWN PROCEDURESInside the moduleGxP training
Training built from your controlled documents, signed under Part 11 at completion, and reassigned when a document changes.
21 CFR PART 11Inside the moduleDocument control
Every revision as a numbered change: checked before review, signed off by class, and in force at the last signature.
DRAFT · REVIEW · IN FORCEInside the moduleThe core under every module
Every organisation has the core, whichever modules it picks. It is what makes a record hold up: who did what, why, and under whose signature.
- ·01An audit trail written with the change
- Who, when, why, and what it was before and after, written in the same transaction as the change itself. Each entry is chained to the one before by its hash, so an edited or removed entry shows.
- ·02Signatures as records
- A Part 11 signature is a record of its own: a fresh sign-in, the name, the time and what it means. Completing, publishing, waiving and reopening are each signed.
- ·03Named duties
- Name who authors, who approves, who holds quality assurance and who manages which groups. Where you require it, whoever wrote something cannot be the one who releases it.
- ·04An inbox, oldest first
- What is yours to sign, review or chase, longest owed first. Turn reminders on and people hear before a date falls due and once when it passes.
- ·05What changed, side by side
- Two versions of any document compared paragraph by paragraph, by section, on the pages themselves, with neolumi's summary checked against the comparison.
- ·06Your library, where it lives
- Synced from SharePoint or Veeva Vault, or uploaded. Every version is kept, hashed and archived.
When modules meet
Start with one module. Each one you add reads what the others already hold, so nothing is entered twice.
EVERY TENANTTHE CORE
ON TOPONE OR MORE MODULES
EACH ONE ADDEDREADS THE OTHERS
- ·01 + ·03WHO IS TRAINED
- Assessment and training. A clause's record says who is trained on the documents that evidence it.
- ·04 + ·03WHO RETRAINS
- Document control and training. A training is built only on a document in force. A substantive change retrains; an editorial one carries the training onto the new revision.
- ·04 + ·01 ·02CHECKED FIRST
- Document control and both assessments. Before review, a draft is read against every clause and every one of your own rules that reads its document. Whatever it makes worse is fixed, or settled with a reason, before anyone signs.
- ·04 + ALLWHAT IT REACHES
- A change, before it is signed. Who retrains, which clauses and rules quote the document, and which documents cite it and would be left out of step.