Where your quality system stands against a standard, clause by clause, and the page in your own documents behind every answer.
- ·01The standard, clause by clause
- 21 CFR Parts 4, 210 and 211 and ISO 13485:2016, each broken into its clauses and kept by neolumi. Your team starts from the standard, not a spreadsheet.
- ·02Read against everything
- Each clause is read against your whole document library and judged covered, partial, gap or not applicable.
- ·03Cited to the page
- A finding quotes the passage it rests on, located in the document and page it came from. A quote that cannot be found there does not stand.
- ·04Your reviewer decides
- Your quality team confirms or corrects each finding, and a correction carries its reason. Export the register as PDF or CSV.
STANDARD21 CFR 211
READ AGAINSTWHOLE LIBRARY
EXPORTPDF · CSV
- 211.25COVERED
- Personnel qualifications. Training in each person’s own operations and in current GMP is required, and a record of it is kept.CITED · SOP-TRN-002 · P.3
- 211.100PARTIAL
- Written procedures; deviations. Production and process control procedures exist, but none requires a deviation from them to be recorded and justified.CITED · SOP-PRD-005 · P.2
- 211.192GAP
- Production record review. Nothing in the library requires an unexplained discrepancy to be investigated before a batch is released.