Who should comply with SOC 2 Attestation?

SOC 2 audit is a prerequisite for service organizations dealing or engaged, in technology-based services that store client information in the cloud. This would include SaaS Cloud computing service providers, and Software Service providers to name a few.

How much would a SOC 2 Audit cost?

SOC2 Audit cost for an average-sized company starts at $15000. Pricing for a SOC 2 audit usually depends on several factors, including the Scope of SOC2 Audit, Types of Report, Business Applications, Technology Platforms, Number of Locations, Trust Services Criteria to be included in the audit, and other additional services.

How long would it take to complete a SOC 2 Audit?

On average it takes 8-12 weeks to complete a SOC2 Audit with reporting. However, the timeline also greatly depends on the time taken for implementing the remediation suggested in the gap analysis.

What will you get after a SOC 2 Audit is complete?

You will receive SOC 2 reports documenting the details of the effectiveness of the Service Organization’s system and controls. The report will detail information about how your client information is maintained securely with all necessary controls in place. Additionally, we also provide a “Certificate of Compliance” that you can show your clients and proudly hang on your office walls and conference rooms.

What is the validity of a SOC 2 report and how often should an audit be conducted?

A SOC2 Report is only valid for a year or 12 months from the date of issue and as per the Industry Standard requirement, a SOC2 Audit must be performed annually, or after significant changes are introduced that may impact systems and control in an environment.

How does a SOC 2 Attestation benefit you?

SOC 2 attestation demonstrates your commitment to maintaining strong internal controls, helps build client trust, improves processes, differentiates your organization from competitors, and protects your brand reputation by reducing the risk of security incidents.

FDA CFR part 11 Compliance Audit Services

FDA CFR Part 11 Compliance and Audit

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FDA CFR Part 11 Compliance and Audit

FDA 21 CFR Part 11 is an important regulation for life sciences, pharma, biotech, and medical device companies. It mainly governs how electronic records and electronic signatures (ERES) are created, stored and managed, making sure there is integrity, security and traceability. Not complying can lead to FDA warning letters, product recalls, legal issues and even reputational damage, all of which may disrupt operations and reduce stakeholder trust.

At VISTA InfoSec, we make FDA 21 CFR Part 11 compliance a bit more simple. Backed with CREST accreditation and decades of industry experience, our team gives clear guidance and practical support to help organizations achieve and also maintain compliance. Whether you’re setting up electronic systems for first time or improving existing ones, we help you align with FDA expectations in an efficient and effective way.

We also provide AuditFusion360, our integrated compliance model which combines Part 11 assessments with other frameworks like ISO 27001, SOC 2, HIPAA and GxP. By bringing overlapping requirements together into one process, AuditFusion360 helps reduce audit fatigue, cut down duplicate controls and gives you one consolidated view of your compliance posture.

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Our FDA 21 CFR Part 11 Services

Advisory Services

Strategic guidance to help your team interpret Part 11 requirements, identify compliance gaps, and build a clear, risk-based roadmap for implementation.

Compliance Consulting

Hands-on support to develop or refine SOPs, validation documentation, system configurations, and risk assessments, ensuring both technical and procedural alignment with Part 11.

Readiness & Independent Audit

Comprehensive assessments of your electronic systems, records, and signatures. We review controls, documentation, and validation evidence to confirm compliance readiness and prepare you for FDA inspections.

FDA 21 CFR Part 11 Audit Methodology

Scoping & Planning

Define applicable systems, records, and processes subject to Part 11. Establish timelines, data collection requirements, and overall audit objectives. Where needed, integrate with AuditFusion360 to cover multiple compliance frameworks in one engagement.

Documentation Review

Assess SOPs, validation protocols, training records, access controls, and change management processes against Part 11 expectations.

System & Technical Assessment

Evaluate electronic systems for audit trails, data integrity, access control, encryption, and compliance with technical criteria under Part 11.

Procedural Evaluation

Verify operational practices against written policies to ensure consistency with FDA regulatory requirements.

Electronic Signature Verification

Review controls for uniqueness, linking, and security of electronic signatures to their corresponding records.

Gap Analysis & Risk Prioritization

Identify deviations, classify their severity, and prioritize remediation efforts based on regulatory impact and operational risk.

Audit Reporting & Exit Meeting

Deliver a comprehensive report with findings, references to FDA requirements, and corrective action recommendations.

FDA 21 CFR Part 11 Audit Deliverables

Independent Part 11 Audit Report

Full compliance status with detailed findings and gap analysis.

Risk Assessment Summary

Clear mapping of risks to data integrity and compliance, with recommended mitigations.

Corrective Action Plan (CAP)

A prioritized roadmap to remediate non-compliance and strengthen controls.

Updated SOP Recommendations

Practical recommendations for aligning policies and procedures with FDA standards.

AuditFusion360 Consolidated Report (if applicable)

Unified reporting across FDA Part 11 and other frameworks, streamlining compliance oversight.

Ongoing Support for FDA 21 CFR Part 11 Compliance

Staying compliant isn’t a one-time task—it’s an ongoing commitment. We help you stay ahead with:

Annual Part 11 Compliance Audits & Reviews

Periodic audits to maintain alignment with evolving FDA regulations and guidance.

Regulatory Intelligence & Updates

Alerts and advisory support on FDA enforcement trends, warning letters, and regulatory changes impacting Part 11.

Training & Awareness Programs

Role-based training for staff handling electronic records and signatures, designed to minimize compliance risk.

Remediation & Follow-up Assessments

Targeted reviews to validate corrective actions and confirm readiness for FDA inspections.

Multi-Framework Compliance Management (AuditFusion360)

Ongoing alignment of Part 11 compliance with ISO 27001, HIPAA, SOC 2, and GxP through our integrated model.

Technical & Procedural Support

Continuous assistance with system validation, documentation updates, and audit trail reviews.

Why work with VISTA InfoSec?

Vendor Neutral Solution- We provide a vendor-neutral assessment of your public/private/hybrid cloud options.
Industry Expertise- We will share industry-specific insight and provide relevant recommendations for achieving your goals of compliance.
Years of Experience- Your organization will benefit from our decade long years of Industry experience and knowledge.
Benchmark Standards- Using well-accepted benchmarks from CSA and NIST, we help organizations assess and secure their Cloud strategies.
International Frameworks- Using globally recommended frameworks from NIST, ENISA, CCM, we help organizations manage risks.
Robust Security & Risk Management Solution- Our state-of-the-art assessment framework effectively helps identify and mitigate infrastructure based risks on the cloud in context to insider access, ancillary data, software isolation, and availability.
Report Detailing the Analysis Finding- We will provide you documents detailing the findings of the analysis and provide relevant recommendations for the same.
Assessment & Certification- We also provide C-Star assessment and certification.
Strictly No Outsourcing- We value your trust in us so we do not outsource your critical assignments to another third party.

Frequently Asked Questions on FDA CFR Part 11 Compliance

What is the main purpose of CFR Part 11?

The purpose of establishing CFR Part 11 is to ensure the authenticity of electronic data and signatures and make them equivalent to paper records and handwritten signatures.

Who does 21 CFR Part 11 apply to?

The 21 CFR Part 11 applies to clinical research organizations, pharmaceutical, and medical device companies, who are conducting FDA-regulated research. Any organizations conducting clinical research in the U.S, or submitting their drugs and devices to the FDA for approval, need to comply with CFR Part 11. Every tech or medical device used in clinical research must be compatible with the CFR Part11.

Which records do 21 CFR Part 11 apply to?

The 21 CFR Part 11 applies to any records that are required by the FDA and are being maintained electronically instead of in a physical format. This includes any electronic document records required by the FDA and mentioned in the Predicate Rule.

What does 21 CFR Part 11 require related to electronic signatures?

The FDA considers electronic signatures equivalent to handwritten signatures but requires the electronic signatures to include the printed name of the signer, date and time of the signature executed, unique user ID, digital adopted signature, and meaning of the signature with labeled signing reason.

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FDA 21 CFR Part 11 – What Every Business Must Know?

Last Updated on October 29, 2025 by robson nadar Imagine

FDA CFR Part 11, ICH GCP, GMP, (CSV)- What’s the hype all about?

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FDA CFR Part 11 Compliance and Audit

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FDA CFR Part 11 Compliance and Audit

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