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Auditing Computer Systems for Part 11 and International Compliance

This course equips regulated industry professionals to evaluate computer systems, electronic records, and signatures against FDA and international compliance expectations while reducing validation gaps, audit exposure, and data integrity risks across the system life cycle. This Course is designed for professionals managing regulated computerized systems, validation activities, compliance oversight, data integrity, and operational controls.

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US $190 per learner

30-Days Unlimited Streaming Access

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REGISTER FOR THE COURSE

To Get 30-Day Access to ONLY this Course 

US $190 per learner
  • This course is Included in Subscription Pack
Subscription include access to entire Learning Library
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  • Instructor : Carolyn Troiano
  • Study time : 90 Minutes
  • Skill Level: Intermediate
  • Course ID: TF3546
  • Assessment & Certification Included
  • Ask the Expert

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About the Course

Computerized systems supporting FDA-regulated activities must remain validated throughout their operational life cycle while maintaining reliable control over electronic records and electronic signatures. Regulatory expectations under 21 CFR Part 11, Annex 11, and GDPR continue to affect how organizations implement, document, secure, review, and maintain systems used across research, manufacturing, laboratories, quality operations, clinical environments, and post-market activities across regulated organizations.


Organizations using paperless or partially electronic processes face increasing scrutiny around user access, password management, signature attribution, segregation of duties, audit readiness, and long-term data integrity assurance. System implementation decisions intended to improve efficiency can also introduce additional oversight burdens if validation practices, documentation controls, and maintenance procedures are not clearly defined. Effective auditing of computerized systems requires a practical understanding of current compliance expectations, inspection observations, validation methodologies, and operational responsibilities tied to electronic record and signature functionality.

  • Strengthen Audit and Inspection Readiness:

    Organizations operating validated systems must demonstrate consistent control over electronic records, signatures, user access, and documented validation activities. This course clarifies common inspection deficiencies, current expectations tied to computerized systems, and practical actions that reduce unnecessary audit delays, compliance observations, and operational disruption during regulatory review.

  • Improve Validation Oversight Across System Life Cycles:

    Computer system validation requires ongoing coordination between technical, quality, and operational functions as systems evolve. Participants gain practical insight into SDLC support for validation, validated-state maintenance, documentation practices, and data integrity controls for both structured and unstructured records as regulatory expectations and technologies continue changing.

Key Areas Covered

  • 21 CFR Part 11 and Annex 11 requirements for electronic records, electronic signatures, and validated systems
  • GDPR expectations affecting computerized systems and regulated data management practices
  • System Development Life Cycle methodologies supporting computer system validation activities
  • Documentation practices required to maintain systems in a validated operational state
  • Data integrity assurance for structured databases, documents, images, and electronic signatures
  • Regulatory audit participation practices, inspection observations, warning letter trends, and risk reduction measures
  • Electronic signature controls, user authentication requirements, and segregation of duties expectations
  • Current validation trends, emerging best practices, and operational impacts of evolving regulatory oversight

Who Must Attend

  • Information Technology Departments
  • QA/QC Departments
  • Audit Departments
  • Computer System Validation Departments
  • Compliance Professionals
  • Laboratory Operations Departments

Quality training, expert insights, and answers that matter. Know your Expert

CAROLYN TROIANA

Carolyn Troiano has more than 30 years of experience supporting computer system validation initiatives within pharmaceutical, medical device, animal health, tobacco, and other FDA-regulated industries. Her background includes developing validation strategies since the 1980s, advising organizations on large-scale IT system implementation projects, and collaborating with FDA and industry representatives on 21 CFR Part 11. Her consulting work focuses on maintaining validated systems, regulatory compliance practices, and electronic record and signature requirements relevant to computerized system audits.

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Ready to Strengthen Your Team? Let’s Build Your Training Plan.

Whether you’re looking for a single onsite workshop or a multi-team training series, we’ll help you design a program that fits your goals, timelines, and operational reality.

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Your organization deserves the confidence.

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Our students love us ❤️

“Liked that the session stayed practical. The points on audits and documentation were useful for our group.”

Lead, Information Technology Departments

“Covered the topic without making it overly technical. The examples tied in well with current system compliance work.”

Supervisor, Compliance and Audit Departments

“Presenter knew where to spend time and where to move quickly. That made a difference.”


Director, Quality Assurance


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