1. What is the primary objective of **FDA 21 CFR Part 11**?

**The primary objective of FDA 21 CFR Part 11 is to establish criteria under which the Agency considers electronic records and electronic signatures trustworthy, reliable, and equivalent to paper records and handwritten signatures executed on paper.** Per §11.1(a), it ensures authenticity, integrity, confidentiality (when appropriate), and non-repudiation for records created, modified, maintained, archived, retrieved, or transmitted under predicate rules.

2. Who is legally or professionally required to comply with **FDA 21 CFR Part 11**?

**FDA 21 CFR Part 11 applies to organizations using electronic records in lieu of paper for predicate-rule-required records, relying on electronic records for regulated activities, submitting accepted electronic records to FDA, or using legally binding electronic signatures.** It targets life sciences firms (pharma, biotech, devices) maintaining such records under regulations like 21 CFR Parts 211 or 820; paper-reliant systems are generally exempt per 2003 guidance.

3. Does **FDA 21 CFR Part 11** require an external audit or third-party certification?

**No, FDA 21 CFR Part 11 does not require external audits or third-party certification.** Compliance is demonstrated through internal controls, validation, SOPs, and inspection readiness (§11.1(e)); FDA verifies during inspections. The 2003 guidance emphasizes predicate rule enforcement without mandating certifications.

4. How often should an assessment for **FDA 21 CFR Part 11** be performed?

**FDA 21 CFR Part 11 does not prescribe a fixed frequency for assessments; organizations must perform risk-based periodic reviews tied to change control, system lifecycle, and predicate rules.** Per GAMP practices and 2003 guidance, reassess scope, validation, and controls during changes, annually for critical systems, or post-inspection to ensure ongoing fitness for use.

5. What are the consequences of non-compliance with **FDA 21 CFR Part 11**?

**Non-compliance with FDA 21 CFR Part 11 can result in FDA Form 483 observations, warning letters, product holds, recalls, fines up to $10,000 per violation, and injunctions.** Predicate rule violations remain enforceable; data integrity failures (e.g., weak audit trails) trigger enforcement, as seen in warning letters citing inadequate investigations and CAPA.

6. Can **FDA 21 CFR Part 11** be mapped to other international frameworks?

**Yes, FDA 21 CFR Part 11 controls can be mapped to frameworks like EU Annex 11 for electronic records/signatures, emphasizing aligned principles of data integrity, audit trails, and validation.** Risk-based approaches and ALCOA+ facilitate harmonization, though Part 11-specific elements like §11.100(c) certification apply uniquely.

7. What is the first step to begin implementing **FDA 21 CFR Part 11**?

**The first step to implement FDA 21 CFR Part 11 is to establish a formal applicability framework mapping predicate rules to records and assessing business reliance on electronic versions.** Document scope decisions in SOPs per 2003 guidance, classifying systems as closed/open and prioritizing high-risk controls like access limitation (§11.10(d)).

What is the primary objective of **ISO 27017**?

**ISO 27017 provides cloud-specific implementation guidance for 37 ISO 27002 controls plus 7 additional cloud-specific controls (CLD.6.3.1, CLD.8.1.5, CLD.9.5.1, CLD.9.5.2, CLD.12.1.5, CLD.12.4.5, CLD.13.1.4).** Published in 2015, it addresses shared responsibilities between **cloud service providers (CSPs)** and **cloud service customers (CSCs)**, covering multi-tenancy segregation, virtual machine hardening, asset return/termination, administrative operations security, customer monitoring, and network alignment in public, private, and hybrid clouds.

Who is legally or professionally required to comply with **ISO 27017**?

**No organization is legally required to comply with ISO 27017, as it is a voluntary code of practice.** Professionally, **CSPs** and **CSCs** with significant cloud footprints adopt it to demonstrate due diligence, meet procurement demands, and enhance ISO 27001 ISMS for cloud risks like shared responsibility and multi-tenancy.

Does **ISO 27017** require an external audit or third-party certification?

**ISO 27017 does not support standalone third-party certification or require external audits.** It is implemented within an **ISO 27001** ISMS, where auditors assess its 37 extended and 7 **CLD** controls during ISO 27001 Stage 1/2 audits, often noted as an extension in certificates.

How often should an assessment for **ISO 27017** be performed?

**ISO 27017 assessments occur as part of annual ISO 27001 surveillance audits and triennial re-certification.** Controls are reviewed continuously via risk assessments, with formal external verification typically annually to confirm implementation in cloud environments.

What are the consequences of non-compliance with **ISO 27017**?

**Non-compliance with ISO 27017 carries no direct legal penalties, as it is voluntary.** Indirect risks include failed procurement RFPs, regulatory scrutiny for inadequate cloud security, heightened breach exposure from unaddressed risks like multi-tenancy failures, and loss of ISO 27001 certification if cloud controls are deficient.

Can **ISO 27017** be mapped to other international frameworks?

**Yes, ISO 27017 maps directly to ISO 27001/27002 controls and aligns with frameworks like NIST SP 800-53 and CSA STAR via its 37 extended and 7 CLD controls.** Organizations use control matrices for cross-compliance, such as shared responsibility to FedRAMP baselines.

What is the first step to begin implementing **ISO 27017**?

**Conduct a cloud-specific risk assessment within your ISO 27001 ISMS to identify applicability of the 37 ISO 27002 and 7 CLD controls.** Define scope, shared responsibilities (CLD.6.3.1), and update the Statement of Applicability before technical implementation.

FDA 21 CFR Part 11 vs ISO 27017

Standards Comparison

FDA 21 CFR Part 11

Mandatory

1997

FDA regulation for trustworthy electronic records and signatures

ISO 27017

Voluntary

2015

Code of practice for cloud-specific information security controls

Quick Verdict

FDA 21 CFR Part 11 mandates electronic records/signatures trustworthy for life sciences, while ISO 27017 provides voluntary cloud security guidance for all industries. Companies adopt Part 11 for FDA compliance, ISO 27017 for global cloud assurance.

Electronic Records

FDA 21 CFR Part 11

21 CFR Part 11 Electronic Records; Electronic Signatures

Cost

€€€€

Complexity

Medium

Implementation Time

18-24 months

Key Features

Establishes equivalency of electronic records to paper records
Mandates secure, time-stamped audit trails for changes
Requires unique electronic signatures with non-repudiation
Differentiates controls for closed versus open systems
Applies risk-based enforcement discretion via FDA guidance

Cloud Security

ISO 27017

ISO/IEC 27017:2015

Cost

€€€

Complexity

Medium

Implementation Time

6-12 months

Key Features

Clarifies shared responsibilities between CSPs and CSCs
Introduces 7 cloud-specific CLD security controls
Provides guidance for 37 ISO 27002 controls in cloud
Addresses multi-tenancy segregation and VM hardening
Integrates as extension to ISO 27001 ISMS audits

Detailed Analysis

A comprehensive look at the specific requirements, scope, and impact of each standard.

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 narrowed by 2003 FDA guidance.

Key Components

Subparts A-C cover scope, electronic records (closed/open systems controls like validation, audit trails, access), and signatures (manifestation, linking, uniqueness).
Core controls: access limitation, operational/authority/device checks, training, accountability policies.
No fixed control count; focuses on authenticity, integrity, non-repudiation.
Compliance via validation, not certification.

Why Organizations Use It

Meets legal obligations for electronic recordkeeping in pharma, devices, biotech.
Mitigates enforcement risks (warnings, holds).
Enhances data integrity, inspection readiness, efficiency.
Builds trust with regulators, partners.

Implementation Overview

Risk-based scoping, CSV (IQ/OQ/PQ), SOPs, training.
Phased: gap analysis, validation, go-live, monitoring.
Targets life sciences; U.S.-focused but global relevance.
No external certification; FDA inspection demonstrates compliance.

ISO 27017 Details

What It Is

ISO/IEC 27017:2015 is an international code of practice providing cloud-specific guidance for information security controls within an ISO 27001 ISMS. It extends ISO/IEC 27002 with tailored implementation advice for cloud environments, focusing on shared responsibilities, multi-tenancy, and virtualization risks across IaaS, PaaS, and SaaS models using a risk-based approach.

Key Components

Additional guidance for 37 ISO 27002 controls adapted to cloud contexts
7 new CLD controls covering shared roles, asset lifecycle, VM segregation/hardening, admin operations, monitoring, and network alignment
Structured around ISO 27002 domains like access control and operations security
Assessed via ISO 27001 audits, not standalone certification

Why Organizations Use It

Clarifies CSP-CSC responsibilities to prevent security gaps
Meets regulatory (GDPR/CCPA) and procurement demands
Reduces cloud incident risks like misconfigurations
Enhances trust, differentiation for CSPs, and due diligence for customers

Implementation Overview

Integrate into ISO 27001 ISMS through risk assessment and control mapping
Activities: document responsibilities, configure segregation/monitoring, update SLAs
Suits CSPs/CSCs globally, all sizes; joint audits typically 9-12 months

Key Differences

Aspect	FDA 21 CFR Part 11	ISO 27017
Scope	Electronic records/signatures equivalence to paper	Cloud-specific information security controls
Industry	FDA-regulated life sciences (pharma, devices)	All industries using cloud services globally
Nature	Mandatory U.S. FDA regulation	Voluntary ISO guidance/code of practice
Testing	Risk-based system validation, audit trails	ISO 27001 audits with cloud control assessment
Penalties	Warning letters, enforcement actions	No legal penalties, certification loss

Scope

FDA 21 CFR Part 11

Electronic records/signatures equivalence to paper

ISO 27017

Cloud-specific information security controls

Industry

FDA 21 CFR Part 11

FDA-regulated life sciences (pharma, devices)

ISO 27017

All industries using cloud services globally

Nature

FDA 21 CFR Part 11

Mandatory U.S. FDA regulation

ISO 27017

Voluntary ISO guidance/code of practice

Testing

FDA 21 CFR Part 11

Risk-based system validation, audit trails

ISO 27017

ISO 27001 audits with cloud control assessment

Penalties

FDA 21 CFR Part 11

Warning letters, enforcement actions

ISO 27017

No legal penalties, certification loss

Frequently Asked Questions

Common questions about FDA 21 CFR Part 11 and ISO 27017

FDA 21 CFR Part 11 FAQ

ISO 27017 FAQ

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FDA 21 CFR Part 11

ISO 27017

Quick Verdict

FDA 21 CFR Part 11

Key Features

ISO 27017

Key Features

Detailed Analysis

FDA 21 CFR Part 11 Details

What It Is

Key Components

Why Organizations Use It

Implementation Overview

ISO 27017 Details

What It Is

Key Components

Why Organizations Use It

Implementation Overview

Key Differences

Scope

Industry

Nature

Testing

Penalties

Frequently Asked Questions

FDA 21 CFR Part 11 FAQ

1. What is the primary objective of FDA 21 CFR Part 11?

2. Who is legally or professionally required to comply with FDA 21 CFR Part 11?

3. Does FDA 21 CFR Part 11 require an external audit or third-party certification?

4. How often should an assessment for FDA 21 CFR Part 11 be performed?

5. What are the consequences of non-compliance with FDA 21 CFR Part 11?

6. Can FDA 21 CFR Part 11 be mapped to other international frameworks?

7. What is the first step to begin implementing FDA 21 CFR Part 11?

ISO 27017 FAQ

What is the primary objective of ISO 27017?

Who is legally or professionally required to comply with ISO 27017?

Does ISO 27017 require an external audit or third-party certification?

How often should an assessment for ISO 27017 be performed?

What are the consequences of non-compliance with ISO 27017?

Can ISO 27017 be mapped to other international frameworks?

What is the first step to begin implementing ISO 27017?

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Using CIS Controls v8.1 as a ‘Compliance On-Ramp’: Map One Security Program to NIST CSF, ISO 27001, PCI DSS, and NIS2

How to Implement CIS Controls v8.1 as a ‘Control Backbone’ for NIS2 & DORA (Step-by-Step Implementation Guide)

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