Technical notes
Questions we meet in the field and how we solve them: serialization, predictive maintenance, data and regulation.
- 3 min readFive common errors in pharma serialization codes and how to catch them on the lineMissing separators, wrong check digits, date format mix-ups, duplicate serial numbers and disallowed characters: the most frequent errors in pharma DataMatrix codes and how to prevent each one on the line.
- 2 min readStarting predictive maintenance without labeled failure dataPredictive maintenance does not need a dataset of labeled past failures. Learning normal behavior, linking alarms to a physical fault class and collecting labels along the way is a sound start.
- 2 min readAudit trails for 21 CFR Part 11: what to record and howOn the software side, FDA's 21 CFR Part 11 requirements for electronic records and signatures show up most in the audit trail. What to record, immutability, retention and a short checklist for electronic signatures.