POPIA
South Africa’s comprehensive personal information protection regulation
FDA 21 CFR Part 11
FDA regulation for electronic records and signatures equivalence
Quick Verdict
POPIA mandates comprehensive personal data protection across South African organizations, while FDA 21 CFR Part 11 ensures electronic records/signatures are trustworthy for life sciences. Companies adopt POPIA for privacy compliance, Part 11 for FDA-regulated digital equivalence.
POPIA
Protection of Personal Information Act, 2013 (Act 4 of 2013)
Key Features
- Protects personal information of juristic persons
- Mandates eight conditions for lawful processing
- Requires mandatory Information Officer appointment
- Ultimate accountability for Responsible Parties
- Continuous security risk management cycle
FDA 21 CFR Part 11
21 CFR Part 11 Electronic Records; Electronic Signatures
Key Features
- Secure time-stamped audit trails for all actions
- Validation ensuring system accuracy and reliability
- Electronic signatures equivalent to handwritten ones
- Access controls limiting to authorized individuals
- Controls for open systems with encryption
Detailed Analysis
A comprehensive look at the specific requirements, scope, and impact of each standard.
POPIA Details
What It Is
POPIA (Protection of Personal Information Act, 2013, Act 4 of 2013) is South Africa’s comprehensive data protection regulation. It governs processing of personal information of natural and juristic persons via an accountability-based approach with eight conditions for lawful processing.
Key Components
- **Eight conditionsAccountability, processing limitation, purpose specification, further processing limitation, information quality, openness, security safeguards, data subject participation.
- **Core elementsData subject rights, operator contracts, breach notification, prior authorisation for high-risk activities.
- **EnforcementOverseen by Information Regulator with fines up to ZAR 10 million.
Why Organizations Use It
- Legal compliance mandatory for all processors in South Africa.
- Mitigates fines, criminal penalties, civil claims.
- Builds trust, enables secure data flows, supports GDPR-like global operations.
Implementation Overview
- Phased: Gap analysis, data mapping, governance (Information Officer), security controls, rights workflows.
- Applies universally across sectors, sizes; no certification but Regulator audits.
FDA 21 CFR Part 11 Details
What It Is
FDA 21 CFR Part 11 is a U.S. regulation establishing criteria for electronic records and electronic signatures to be trustworthy, reliable, and equivalent to paper records and handwritten signatures. It applies to FDA-regulated industries using electronic systems for predicate-rule records, employing a risk-based approach with controls for closed and open systems.
Key Components
- Subparts A-C cover scope, electronic records (§11.10/§11.30), and signatures (§11.50-§11.300).
- Core controls: validation, audit trails, access limits, operational/authority/device checks, training, accountability policies.
- Built on ALCOA+ principles; no formal certification, but FDA enforcement via inspections.
Why Organizations Use It
- Ensures compliance with predicate rules like CGMP.
- Mitigates data integrity risks, avoids warning letters.
- Enables paperless operations, improves efficiency, builds stakeholder trust.
Implementation Overview
- Phased: scoping, gap analysis, validation (IQ/OQ/PQ), SOPs, training.
- Targets life sciences firms; global via harmonization; audit via FDA inspections.
Key Differences
| Aspect | POPIA | FDA 21 CFR Part 11 |
|---|---|---|
| Scope | Personal information processing lifecycle | Electronic records/signatures equivalence |
| Industry | All sectors in South Africa | Life sciences, FDA-regulated products |
| Nature | Mandatory comprehensive privacy regulation | Electronic records technical regulation |
| Testing | Security risk assessments, DPIAs | System validation IQ/OQ/PQ |
| Penalties | ZAR 10M fines, 10yr imprisonment | Warning letters, product holds |
Scope
Industry
Nature
Testing
Penalties
Frequently Asked Questions
Common questions about POPIA and FDA 21 CFR Part 11
POPIA FAQ
FDA 21 CFR Part 11 FAQ
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