The order of an inspection is set by the investigator.
Two quality systems are in scope: your own, and that of the API supplier you qualify. Aligntra reads each against the standard that applies to it.
Management responsibility, continual improvement and the product lifecycle model.
Good manufacturing practice for active pharmaceutical ingredients.
Bars to scale.
Your quality system, and the one you qualify.
Each is read against the standard that governs it, by the same engine, in the same pass. The supplier’s system is the larger of the two and the one you see least of.
The CAPA record is closed on completion of the corrective step.
The procedure contains no requirement to verify that the action was effective, and the form provides no field to record it.
Changes are routed to the originating department for review.
No step routes the change to the quality unit before it takes effect.
Illustrative, prepared for this page. No ICH example audit is published.
An investigator, from documents selected on site, in an order set during the inspection.
Their own inspector. You receive a questionnaire response and a certificate; the underlying procedures are not normally provided.
Three investigators, three routes, the same document set.
Which documents are opened, and in what sequence, is decided during the inspection. Preparation aimed at one route is preparation aimed at a route you were not given.
Illustrative. The document set is the same in all four rows; the selection is not. Aligntra assesses each obligation in both standards, against the documents provided.
When each obligation is assessed, the inspection scope does not need to be predicted.
Preparation limited to a predicted scope leaves the rest of the documentation unexamined.
Commission a mock inspection
A former investigator reviews the site over two days and issues a report.
The report reflects the documentation as it stood on the day of the visit.
Maintain a compliance matrix
Q7 and Q10 clauses in one column, procedure numbers against them.
It records the mapping. Whether the procedure meets the obligation is not assessed.
Rely on the inspection
The investigator selects the documents and works through them in their own order.
Findings are raised on site, within the inspection.
Read all of it first
Each obligation in both standards, assessed against your documents and your supplier’s, cited to the paragraph.
A reviewer in your organisation confirms, reclassifies or dismisses each finding before it enters a report.
Yes. Both are available for audits and are marked as beta in the product. The obligation counts above come from the live registry, and findings cite the document, page and paragraph the same way they do on a non-beta standard.
Not as records. Deviation and change-control procedures are assessed against their applicable clauses like any other document. The records produced under them are not verified against those procedures. Record verification covers CAPA and NCR.
No. It performs the documentation review a consultant begins with, across the full document set. Walkthroughs, interviews and judgement calls remain with a person.
No. Each standard is a separate audit against the same document set, and each returns its own verdict.
A reviewer in your organisation. Aligntra proposes findings; each one is confirmed, reclassified or dismissed by a person before it enters the report.
*In beta. Available for audits and marked as beta in the product.
Run a review against your own documentation.
Aligntra reads your procedures against ICH Q7 and Q10 and reports each finding with the document, page and paragraph it was drawn from.