Notes from a regulated practice.
Short explainers on the frameworks pharmacy software runs under, written the way the practice reads them: the provision first, the mechanism second, no slogans. Each note states what the law requires, where operations actually fail it, and what software can and cannot carry.
What an electronic batch record must hold under 21 CFR 211.188
The thirteen things a batch record must document for a 503B facility, the master record it points back to, the investigation it must contain, where Part 11 governs the signatures, and why a skipped step cannot be an available action.
September 7, 2026 · read the note → DEA recordkeepingControlled-substance reconciliation in a compounding pharmacy: what 21 CFR 1304 requires
Initial and biennial inventory, exact count versus estimate, records of receipt and disposal, Form 222, two-year retention, theft or loss within one business day. And what a software reconciliation must do to make the arithmetic close.
September 7, 2026 · read the note → MethodA public-records dossier in one afternoon
A consumer billing dispute, worked registry by registry: a licensing gap found, a complaint pattern established, and a statute-cited demand letter drafted before evening. Every document under a human signature.
August 13, 2026 · read the note → Regulatory frameworks503A vs 503B: what changes for the software
The line between a compounding pharmacy and an outsourcing facility runs through the data model: prescriptions vs batches, state boards vs cGMP, dispensing records vs electronic batch records.
June 11, 2026 · read the note → 21 CFR Part 11What Part 11 actually requires of an audit trail
One sentence of regulation, read closely: secure, computer-generated, time-stamped, never obscuring a prior entry. And the four questions that separate a real trail from slideware.
June 11, 2026 · read the note → Sterile compoundingUSP <797> documentation: where errors actually happen
Garbing records, environmental logs, Beyond-Use Dates, the second check. The same structural failure in different clothes, and what a system can prevent by construction.
June 11, 2026 · read the note → Computerized system validationGAMP 5 Category 5: validating custom-built pharmacy software
What the deep end of the validation framework obliges a vendor to produce, and the difference between a package that is authored and one that is executed.
June 11, 2026 · read the note → Privacy and consentHIPAA and call recording in a pharmacy
Three bodies of law on one phone line: the recording as PHI, state two-party consent, and the TCPA on the outbound side. What the software must provide, and what stays with the covered entity.
June 11, 2026 · read the note →