Course "Validation and Part 11 Compliance of Computer Systems and Data" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

Course Description:

Analytical and other equipment should be qualified and computer systems should be validated to demonstrate suitability for the intended use. Electronic records must comply with FDA Part 11 and EU/PICS GMP Annex 11 requirements to ensure data integrity, security and availability. Recent EU and FDA inspection documents prove that qualification, validation and electronic laboratory are records are on target of inspectors. The large number of warning letters issued to laboratories also demonstrate that they struggle with either understanding or implementing the regulations.

This 2-day course provides the regulatory background and guides attendees through the complete equipment qualification, calibration and computer system validation processes from planning to reporting. It also helps to fully understand not only the text but also the meaning of Part 11 and Annex 11 requirements to ensure and document integrity and other requirements for electronic records and signatures.

The 2-day course not only ensures a full understanding of the regulations and guidelines for equipment and records but also provides templates and examples to develop inspection ready documentation. Interactive exercises will be dispersed into and between the presentations. About 50% of the total time will be dedicated to practical sessions. Here attendees work in small groups on case studies and prepare the answers using prepared fill-in templates. After the course a large variety of tools such as SOPs, validation examples and checklists will be readily available on a dedicated website that can be used to easily implement what they have learned in the course.

Additional Bonus Material for easy implementation (all available as Web download):

  • 70-page primer Analytical Instrument Qualification and System Validation (authored by Dr. Ludwig Huber)
  • 10 SOPs related to validation and qualification of equipment and computer systems, change-control, Risk assessment, maintenance, security and integrity of electronic records
  • Full Set of Qualification examples for an HPLC system
  • Full set of Validation examples of a chromatographic Data System

Learning Objectives:

Attendees will:

  • Learn about the regulatory background and requirements for equipment qualification according to Annex 15, USP <1058>, and computer system validation according to GAMP Guides
  • Learn how to ensure and document integrity of raw data and other records according to Part 11 and Annex 11
  • Be able to explain the difference between equipment calibration, qualification and system validation
  • Learn which equipment/systems need to be qualified or validated
  • Be able to allocate equipment and systems to USP <1058> and GAMP categories and to design and execute qualification/validation protocols accordingly
  • Understand the logic and principles of instrument qualification and system validation from planning to reporting
  • Be able to explain your company’s qualification and validation strategies
  • Understand how to archive raw data from hybrid systems: electronic vs. paper
  • Be able to define and demonstrate Part 11 compliance functionality to auditors and inspectors
  • Be able to develop inspection ready documentation during on-going routine operation
  • Learn how to avoid and/or respond to FDA inspectional observations and warning letters

Seminar Fee Includes:

AM-PM Tea/Coffee
Seminar Material
Attendance Certificate
$100 Gift Cert for next seminar

Who will Benefit:

  • IT/IS managers and system administrators
  • QA managers and personnel
  • Laboratory managers and supervisors
  • Analysts
  • Validation specialists
  • Software developers
  • Regulatory affairs
  • Training departments
  • Documentation departments
  • Consultants

Companies and departments:

  • Pharmaceutical development and Quality control laboratories
  • Quality control laboratories of API manufacturers
  • Contract laboratories
  • Clinical Research Organization
  • Suppliers and service providers of instruments and computer systems

Course Outline:

Sessions indicated with (*) include one or more workshop exercises

Day One (8:30 AM - 4:30 PM) Day Two (8:30 AM - 4.30 PM)

8:30 AM - 9:00 AM: Registration Process

9:00 AM: Session Start

Day 1 – Lectures and Workshop Exercises

Module 1 (*)

Requirements and approaches for Instrument Qualification and Computer System Validation

  • FDA/EU, ICH and PIC/S requirements
  • Lessons from recent FDA Warning Letters and how to avoid them
  • Understanding the terminology: qualification, calibration, verification, validation.
  • EU/PUCS GMP Annex 15: Validation and Qualification
  • USP Chapter <1058> for analytical instruments: current and proposed changes
  • Lessons from GAMP®5 and from the GAMP® guide: “A Risk based Approach to Laboratory Computerized Systems”
  • Planning for cost-effective qualification and validation
  • Which instruments require qualification/validation

Module 2 (*)

Going through the equipment qualification phases

  • Develop a project plan from the master plan
  • Writing requirement specifications
  • Documenting installation and installation qualification
  • Testing for initial operational qualification
  • Leveraging system suitability testing for on-going performance qualification
  • Preparing and executing test protocols
  • Preparing inspection ready documentation
  • Maintenance, requalification and change control

Module 3 (*)

Cost Effective Validation of Computer Systems: Step-by-Step – Part 1

  • Selecting the right validation lifecycle model
  • Going through examples of a complete computer system validation from beginning to end
  • How risk assessments can help to determine the type an extent of validation
  • Defining user requirements based on risk
  • Vendor assessment and supplier agreements
  • Testing and documenting installation
  • Going through examples for OQ and PQ testing
  • Writing the validation report

Module 4 (*)

Validation of Computer Systems – Part II

  • Leveraging validation efforts of identical systems
  • Validation of existing equipment and computer systems
  • Preparing inspection ready validation documentation
  • Integrating the GAMP® guide with USP <1058> for integrated instrument and system validation
  • Special considerations for IT infrastructure qualification and validation of networked systems
  • Validation and use of cloud computing in FDA/EU regulated environments
  • Recommendations for different cloud models and services

Day 2 - Lectures and Workshop Exercises

Module 5 (*)

Validation and control of Excel spreadsheet applications

  • Designing spreadsheets for compliance
  • Validation approach for spreadsheet applications
  • When, what and how much to test?
  • Recommendations from GAMP®5 for testing native Excel functions
  • How to ensure spreadsheet and data integrity
  • Going through examples
  • Excel spreadsheet validation from beginning to the end: A case study that can be used by everybody

Module 6 (*)

Maintaining the validated State of computer systems or Control of Operation and Retirement

  • Ongoing training of users and IT staff
  • System maintenance and data backup
  • Change control: Handling planned and unplanned changes
  • How to deal with security patches
  • Periodic review vs. revalidation
  • Disaster recovery and business continuity
  • Retirement of computer systems and data migration

Module 7(*)

Introduction to FDA 21 CFR Part 11 and EU/PICS Annex 11

  • Objective, scope, current situation and future of Part11
  • Requirements overview and spirit of the regulation
  • Requirements for electronic records
  • Requirements for electronic and digital signature
  • Additional requirements from the PICS/EU Annex 11, and from the UK MHRA and WHO GMP data integrity guidelines
  • FDA/EU inspection and enforcement practices of electronic records: examples of FDA warning letters reports
  • User requirements for Part11/Annex 11 based on risk
  • Upgrading old or purchasing new systems: compliance and business aspects
  • Six steps for implementation of Part11/Annex 11

Module 8(*)

Ensuring and documenting Integrity of Laboratory (Raw)data and other Records

  • Definition of raw data: FDA/EMA requirements
  • What to archive for hybrid systems: paper records or electronic records
  • The importance of electronic audit trail to document data integrity
  • Review of electronic audit trail: who, what, and how
  • How to ensure availability of electronic records throughout the entire retention period
  • The importance of validating security and integrity functions
  • Examples how to ensure and document data integrity using security
  • Preparing your company for data integrity audits

®GAMP is a registered trademark and stands for Good Automated Manufacturing Practice
®Excel is a registered trademark of Microsoft

The concept

  • 50 % of the time will be dedicated to workshop type exercises using prepared fill-in templates and to interactive discussions

Meet Your Instructor

Dr. Ludwig Huber
Chief Advisor - Global FDA Compliance, Labcompliance
  • Chairman, presenter and panel discussion member at US-FDA Industry Training sessions and conferences
  • Served as team member of PDA's task forces "21 CFR Part 11", of US-FDA internal documents, and of the GAMP® special interest group on Laboratory Systems.
  • Presenter of the Year of the Institute for Validation and Technology
  • Director and chief editor of, the global on-line resource for validation and compliance issues for laboratories.
  • Author of the books “Validation and Qualification in Analytical Laboratories, and "Validation of Computerized Analytical and Networked Systems"

For more information, visit

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