Resources

Regulatory foundations of pharmaceutical quality.

Short notes with how QUAIL maps to each. Educational, not legal advice.

Each framework asks who wrote a record, when, and who signed it. QUAIL keeps all three visible on every page it reads.

21 CFR Part 11

FDA rules for electronic records and electronic signatures.

QUAIL · Time-stamped audit trail; human sign-off stays in your process.

Attributable, legible, contemporaneous, original, accurate, and more.

QUAIL · Keeps handwritten floor entries in the review record, unaltered.

Computerized systems: risk-based, validated, interoperable.

QUAIL · Designed to sit beside MES, LIMS, and eBR.

MHRA, PIC/S, WHO, ISPE GAMP 5.

QUAIL · A review layer, not a substitute for your CSV program.

Predicate rule

The GMP requirement that still applies, on paper or electronic.

Audit trail

Secure, time-stamped create / modify / review history.

CSV

Validation of systems that touch GxP data.

Deviation

A departure from an approved instruction that needs investigation.

Bring your questionnaire or CSV plan. We answer in plain language.

Blog and case studies coming soon.