Assurance Use Cases

Real-world scenarios showing how regulated industries use Qualityfolio for evidence-driven test management and assurance

SOC 2 Type II

Continuous Control Evidence

Challenge

Need to prove access controls tested quarterly with auditable evidence for accountability

Solution

Automated test execution with surveilr evidence storage with integrity. Every control test captured with timestamps and provenance for governance.

Evidence Approach

SQL query shows all control tests with execution history and accountability, linked to specific controls

Outcome

Auditor self-service evidence retrieval reduced audit prep time by 70%

FDA 21 CFR Part 11

Software Validation

Challenge

Computer system validation requiring complete audit trails with accountability and electronic signatures

Solution

Markdown validation protocols with immutable evidence and integrity in surveilr. Git provides version control for governance, surveilr provides execution records with accountability.

Evidence Approach

Git history + surveilr execution records with integrity = complete validation package

Outcome

Regulatory submission package for validation generated via SQL export in minutes, not weeks

HIPAA

Technical Safeguards Testing

Challenge

Prove encryption, access controls, audit logs tested regularly per §164.312 for assurance and integrity

Solution

Assurance test suite mapped to HIPAA requirements with FII linkage for accountability

Evidence Approach

Requirement traceability matrix with governance generated from surveilr queries

Outcome

OCR audit preparation time reduced by 80%, zero findings on technical controls

ISO 27001

Information Security Controls

Challenge

Demonstrate control effectiveness with documented evidence for certification and assurance

Solution

Test cases linked to ISO controls (A.9.4.1, A.10.1.1, etc.) via YAML metadata for governance

Evidence Approach

surveilr query showing control test coverage with accountability across all domains

Outcome

Certification audit for assurance completed with zero findings, annual surveillance simplified

GxP

Lab System Validation

Challenge

Validate LIMS and lab instruments with 21 CFR Part 11 validation requirements in air-gapped environment

Solution

Qualityfolio offline mode for air-gapped pharmaceutical lab validation environments

Evidence Approach

Local surveilr database with complete provenance, accountability, and integrity, exportable for regulatory review

Outcome

FDA inspection of validation evidence passed without additional documentation requests

GDPR

Data Protection Testing

Challenge

Prove data deletion, consent management, and privacy controls work as designed with integrity and assurance

Solution

Automated tests for GDPR requirements with evidence capture and accountability for Articles 17, 20, etc.

Evidence Approach

Test results linked to GDPR articles with timestamp, execution logs, and accountability

Outcome

DPA inquiry responded to within 24 hours with complete queryable evidence for assurance

Disclaimer: Qualityfolio provides tooling for assurance test management. It does not guarantee regulatory approval. Always consult with assurance and compliance professionals.