Data Integrity & Records

The finish line

By the end of this course you can apply ALCOA+ to a real electronic record, explain Part 11’s e-signature and predicate-rule requirements — including for hybrid paper/electronic and legacy systems — and describe how Lakeshore’s multi-state data governance holds up under audit. You’ll also finally get full depth on three things csv-and-becs deliberately left as names and pointers: predicate rules, Part 11’s electronic-signature components, and audit-trail review in practice.

This course’s scenario: Lakeshore’s next AABB reassessment cycle is on the calendar, and an FDA inspection could land before it. Your Quality Analyst is running a data-integrity self-assessment across every system that creates or holds a record Lakeshore depends on — not just BECS (Blood Establishment Computer Software), but the paper donor file still used at one satellite site, an aging instrument predating Part 11 entirely, and the cumulative record that tracks a deferred donor across every Lakeshore location. Call it DI-0301. You review her findings module by module, and by the end you can defend every one of them yourself.

Before you start

This course assumes the three foundations and two earlier courses:

The six modules

Each module is one sitting, and each has its own finish line.

  1. ALCOA and data integrity. Define data integrity the way FDA’s own guidance does — ALCOA, five letters, verified from a real source — distinguish it from “ALCOA+,” the broader industry/international term this course will use carefully, and apply both to a real Lakeshore electronic record.
  2. Audit trails and e-signatures in practice. Review an audit trail the way an inspector would — who should review it, how often, what counts as a real review versus a rubber stamp — and name the specific controls (11.50, 11.70, 11.100, 11.200, 11.300) an e-signature has to satisfy to stand in for a handwritten one.
  3. Predicate rules and hybrid systems. Explain what a predicate rule actually is and how it decides whether a given record is a “Part 11 record” at all, and judge whether a system that mixes paper and electronic records — paper as the record of record, electronic as a convenience copy, or the reverse — is handling that mix defensibly.
  4. Assessing a legacy system for Part 11 gaps. Apply FDA’s own four-part legacy-system test to a system older than Part 11 itself, and say what has to be true for continued enforcement discretion to actually hold.
  5. Retention across record types. Go beyond 606.160(d)’s product-record clock — already yours — to the records that don’t share its schedule: donor records, electronic-signature components, audit trails and their metadata, and what “retain the record” actually requires for a dynamic electronic record versus a static printout.
  6. Multi-site governance and donor identification. Explain how Lakeshore keeps one donor’s identity and eligibility history consistent across a central system and every satellite site, using the cumulative deferred-donor record 606.160(e) already requires — and say what breaks if two sites’ records disagree about the same donor.

A note on sources

Two guidance documents carry most of this course’s weight, and both are FDA guidance (current thinking, “should” language) — never binding regulation, even where they’re this precise:

  • FDA’s 2003 Part 11 guidance (Scope and Application), already used in csv-and-becs, returns here for its legacy-system criteria and its enforcement-discretion treatment of record copies.
  • FDA’s 2018 data-integrity guidance (Data Integrity and Compliance With Drug CGMP: Questions and Answers) is new to this course. It was written for drug CGMP (21 CFR Parts 210, 211, 212), not Part 606 directly — it reaches a blood establishment’s records the same way 211.68 always has in this curriculum, through 210.2(a)’s supplementation principle. It defines “ALCOA.” It does not use the term “ALCOA+” anywhere — that distinction matters, and this course keeps it straight throughout.

Modules appear in the sidebar as they’re built.