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Life sciences · GxP

SAP test data for life sciences: GxP validation and HIPAA

Validated SAP systems need test evidence an auditor can trace: which data a script ran on, under which rules, and proof it can be run again. Synthesized gives each validation run a masked, versioned data set, with patient and employee data removed.

Book a health checkGxP requirements

Not regulatory advice: your quality unit decides what evidence you need.

Available on SAP Store
Validation run · OQ-114Example
Data set
Batch records and QM lots, masked
DS-2026-07
Masking rules
Version 12, approved by QA
Approved
Run record
Who ran it, when, and the result
Recorded
Rerun after a patch
Same rules on the same source
Repeatable
Reproducible test evidence
Results measured in live deployments outside SAP
30%
faster testing and development cycles
Global bank · self-service test data
20bn
rows masked and subsetted in hours
Digital health platform · replaced a legacy TDM tool · Read the case study
28M
production rows protected, 100% referential integrity
Global specialty insurer · 40+ core applications · Read the case study
200×
more test data, from 100K to 20M entries
Telecom operator · masking and synthetic generation

On SAP, we measure results on your own data in a 10-day validation.

GxP

What validation asks of test data

EU GMP Annex 11 · FDA 21 CFR Part 11

Computerised systems in GxP

Computerised systems are validated, with documented evidence that they do what they're meant to.

Records, test records included, are attributable, legible and retained, with audit trails.

Changes to validated systems are controlled, and retesting shows the system still works.

Paraphrased. Annex 11 is being revised; check the current text.

Read the source: EU GMP Annex 11, European Commission · 21 CFR Part 11 on eCFR

What it means for SAP

Traceable data
Each run records the rule version and data set, linked to the script that used it.
Repeatable runs
Rerun a script on the same data set after a change, and compare.
No real people
Patient, trial and employee data is masked before testers see it.

HIPAA

Removing protected health information from test data

Where SAP holds health data for a covered entity or business associate, HIPAA's de-identification standard sets what "de-identified" means.

45 CFR 164.514(b)(2)
Safe Harbor
Remove 18 types of identifiers, such as names, small-area addresses, dates other than the year, and record numbers.
45 CFR 164.514(b)(1)
Expert determination
A qualified expert finds the risk of re-identification very small, and documents the method.
In SAP test systems
Masked and synthetic data
Masking replaces identifiers; generation creates records with no real person behind them.

Not legal advice. Your privacy officer decides which method applies.

Read the source: 45 CFR 164.514 on eCFR

How it works

A versioned data set for every validation run

Validation planTest scripts and acceptance criteria
SynthesizedVersioned rules, the same data set every run
Validated SAP QAMasked, reproducible data
Test executionIQ, OQ and PQ scripts
EvidenceRule version, run log, who ran it and when
run record
The same rule version produces the same test data set, so a validation run can be repeated and its evidence traced.
  1. 01

    Approve the rules

    Your quality and privacy teams sign off the masking rules, versioned with the workflow.

  2. 02

    Prepare the data set

    Subset and mask production into the validated QA system: batches, materials, quality lots and the people around them.

  3. 03

    Run and record

    Each run logs the rule version, scope, time and who ran it.

  4. 04

    Rerun after change

    After a patch or upgrade, rebuild the data set from the same rules and rerun the scripts to show nothing broke.

We've got you covered

Questions about GxP and HIPAA test data in SAP

Can we use production data to validate SAP?

You can test on data copied from production, but real patient, trial-participant or employee records in test add privacy risk. Masked data that keeps batches, materials and quality records consistent gives the same coverage.

Does masking affect validation evidence?

Masking becomes part of the documented test setup: the rule version and data set are recorded with each run, so the evidence stays traceable.

Which SAP areas hold GxP data?

Batch management, quality management, plant maintenance, warehouse and serialization records, and the materials and vendors behind them.

Is masked data HIPAA de-identified?

It can be, if it meets Safe Harbor or an expert determination. Your privacy officer decides; we provide the rules and records they need.

Does this fit a risk-based computer software assurance approach?

Risk-based testing needs data you can trust and repeat. Reproducible, masked data sets support it; your quality unit decides how to apply it.

Next step

Plan test data for your next validation

Tell us which SAP system and which scripts. We'll prepare a masked, versioned data set and show a rerun.

Runs in your environmentNothing installed in SAPRead-only access to SAPSecurity and deployment
Book a health checkSecurity and deployment

Related SAP pages

CapabilitySAP data masking and scramblingData maskingComplianceSAP GDPR compliance for test dataGDPR test dataProjectSAP upgrade testingUpgrade testing
Updated October 2026

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