Equipment cleaning and use log
An equipment cleaning and use log is the record required by 21 CFR 211.182: a written log of major equipment cleaning, maintenance and use, kept in chronological order, showing the date, time, product and lot of each batch processed, with the persons performing and double-checking the work each dating and signing or initialing it.
It is a regulated record, not a maintenance convenience.
Dedicated equipment does not get a lighter record; where equipment is dedicated to one product and lots run in numerical sequence, its cleaning, maintenance and use records become part of the batch record instead of a standalone log. Non-dedicated equipment keeps individual logs.
Under 21 CFR 211.180, these records are retained for at least one year after the batch’s expiration date, and the regulation explicitly allows records retrievable by computer from another location to satisfy the availability requirement.
What MYREX does here, and what it does not: MYREX holds the maintenance and use history against the specific machine, records who performed the work with an attestation by an identified user from your own directory, timestamps it server-side, and writes it to a tamper-evident audit trail that can be exported and re-verified outside our software. MYREX does not provide the double-check — there is no second-person verification or countersignature in MYREX today, so on equipment where your procedure requires one, MYREX does not satisfy 211.182 on its own. It also does not hold batch or lot data, and it has no retention or archival capability — retention is a matter for your policy and a written agreement, not a product setting.
Sources and notes
21 CFR 211.182, 211.180, 211.67 (eCFR).
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