ProfileThe candidate verifies that data has survived migration intact. This involves performing independent calculations based on the two files?the export from the source system and the corresponding export from the target system?and reporting any discrepancies. The verification process is implemented independently of the migration process. If the check were based on the same assumptions as the migration itself, there would be a risk of merely reproducing migration errors rather than uncovering them; this is precisely why the separation was established.
SERVICE- Input
- Source system export and target system export, any tabular format.
- No access to the live system required.
- Checks
- Record count reconciliation source to target.
- Primary key integrity: missing, extra, duplicated.
- Field-level value comparison on matched records.
- Field completeness.
- Truncation on free-text fields.
- Character encoding corruption.
- Numeric coercion including leading zero loss.
- Date format drift.
- Null literal substitution.
- Column mapping transposition.
- Output
- Controlled document: document number, revision, status, approval block, scope and limitations statement, findings as condition, criteria, cause, effect and recommendation with severity ratings, acceptance page.
- Machine-readable discrepancy log alongside.
- Boundaries
- No regulatory or clinical determinations.
- No patient-identifiable data required; work is performed on record counts, metadata and field values.
- Delivered white-labelled under the client quality system.
TECHNICAL- Data
- Full FDA MAUDE annual datasets processed end to end: device, narrative and patient files joined across millions of rows, with encoding and delimiter variation handled explicitly.
- Method
- Deterministic pipelines built to fail loudly rather than silently. Record count reconciliation at every stage, explicit fail states, part and merge logic for datasets exceeding a single processing pass, and anti-truncation handling.
- Documents
- ?Controlled document authoring to ISO 13485 clause 4.2.4 conventions. Document control block, revision history, findings structure, severity model, limitations statement, data dictionary, gap register, acceptance page.
REGULATORY KNOWLEDGEGAMP 5 second edition. EU GMP Annex 11. 21 CFR Part 11. ISO 13485. EU MDR post-market surveillance and MDCG 2022-21. 21 CFR 820.198 complaint files. 21 CFR 803 medical device reporting. IMDRF Adverse Event Terminology Annexes A, E and F. QMSR transition effective February 2026.