Analytical Instrument Qualification and Computer System Validation

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Course Overview


Analytical equipment should be qualified and computer systems should be validated to demonstrate suitability for their intended use. To be acceptable to regulatory authorities, electronic records must comply with 21 CFR Part 11, Annex 11 to EU GMPs and more recent data integrity guidance’s. Recent EU and FDA regulatory enforcement actions demonstrate that qualification, validation and electronic records are priority areas for inspection. Recently there have been many FDA warning letters and the frequency of EU enforcement action in these areas.


This training course guides you through equipment qualification, calibration and computer system validation processes from planning to reporting. It also explains regulatory requirements in these areas, including EU and US GMPs, as well as data integrity guidances from national and international regulatory sources. Once completed you will have the confidence to conduct analytical instrument qualification and computer system validation, ensuring you are compliant with global regulations.


With the Educo Post Learning Implementation Plan (PLIP) you will have the framework to apply and implement the knowledge acquired in the training, supporting you in your development. Learn more about how we deliver live online training.

Key Learning Objectives


  • Learn about the regulatory background and requirements for equipment qualification according to USP <1058> and computer system validation according to GAMP 5
  • Be able to allocate equipment and systems to USP <1058> and GAMP 5 categories and to design and execute suitable qualification/validation protocols
  • Understand the logic and principles of instrument qualification and system validation from planning to reporting
  • Be able to develop a qualification and validation strategy
  • Understand how to archive raw data from hybrid systems: electronic vs. paper
  • Be able to define and demonstrate regulatory compliance to auditors and inspectors
  • Learn how to ensure, document and audit the integrity of GMP records
Post Learning Implementation Plan (PLIP)


  • Access to the Educo Training Portal
  • Submit your needs analysis and objectives for training by completing a simple online form

Action Plan

  • At the end of the training you will create an action plan to help you implement and develop your new skills and knowledge

Reinforcement Session

  • Delivered 3 to 4 weeks after the training
  • It is a 1 hour virtual session enabling the group to reinforce the key learnings from the training and cover and subsequent questions and challenges
Day 1

Requirements and approaches for Analytical Instrument Qualification

  • FDA/EU, PIC/S requirements
  • Qualification/calibration issues in FDA inspections
  • USP General Chapter <1058>: Analytical Instrument Qualification
  • The instrument qualification lifecycle
  • Prioritizing calibration/qualification activities


Qualification in Practice

  • User requirement specifications
  • Installation qualification
  • Operational qualification
  • Preparing inspection-ready documentation


Testing and deviation handling

  • Developing test protocols
  • Documenting test evidence
  • Review and approval of test results
  • Handling deviations


Retrospective qualification and Requalification

  • Qualification of existing systems
  • Leveraging past experience
  • Time-based requalification
  • Event-based requalification
  • What and how much to test – risk-based approach


Equipment Maintenance and Change control

  • Preventive maintenance; tasks, documentation
  • Planned and unplanned changes
  • Changing hardware, firmware, documentation
  • Definition and handling of like-for-like changes.
  • Handling changes made by vendors


Type and extend of qualification for USP Instrument Categories

  • The approach and benefits of instrument categories
  • How to identify the correct category: A, B, C
  • Type and extent of qualification for each category
  • Required procedures and qualification deliverables
  • Responsibilities for instrument qualification


Requirements and approaches for GMP Computer Systems

  • 21 CFR Part 211, Part 11, PIC/S, EU Annex 11
  • Recent inspection findings
  • Which systems need to be validated
  • GAMP 5: A Risk based Approach to Laboratory Computerized Systems
  • Examples for risk assessment of computer systems


Validation of Laboratory Computer systems

  • Writing a validation project plan
  • Integrating GAMP 5 with USP <1058> for instrument and computer system validation
  • Writing a validation report


Day 2

Validation and Use of Excel in the QC Laboratory

  • Designing spreadsheets for compliance
  • Validation approach for spreadsheets – single and multiple-use spreadsheets
  • When, what and how much to test?
  • GAMP 5 recommendations
  • How to ensure spreadsheet data integrity


Configuration management and change control

  • Configuration management standards
  • The change control process for planned changes
  • Unplanned changes
  • Upgrading software
  • What to test after changes?
  • How to document changes


Periodic revalidation of chromatography data systems

  • The approach and practice of periodic review
  • Using periodic review to reduce frequency of revalidation
  • Criteria for time-based revalidation
  • Incidents requiring revalidation
  • Validation tasks after installing security and other patches


Handling raw data and other laboratory records

  • Definition of raw data: electronic vs. paper
  • Acquisition and recording of raw data
  • How to make accurate and complete copies of raw data
  • Changing records
  • Archiving of raw data and ready retrieval


Ensuring Integrity and Security of GMP data

  • Most frequent security and data integrity issues
  • The importance of electronic audit trails
  • Review of electronic audit trails: who, what, when and how


Auditing Laboratory Computer Systems

  • FDA inspection practice
  • Importance of data governance policy and controls
  • Preparing inspection-ready documentation
  • Responding to typical inspectional/audit observations


Dr. Mark Powell is a Fellow of the Royal Society of Chemistry (RSC) with over 30 years’ experience as an analytical chemist. In 2003, he helped to set up a UK-based contract research and manufacturing company specialising in early-stage drug development, where he ran the analytical development programme. His responsibilities included commissioning and validating laboratory data systems and training staff.


In 2013, he set up his own company which offers training and consultancy services to the pharmaceutical industry. These include guiding the CMC aspects of drug development programmes and training in areas such as chromatography, dissolution testing, data integrity, method development/validation, analytical instrument qualification, technical writing and auditing.


Mark not only brings a huge amount of knowledge and experience to his workshops but excellent at delivering interactive and engaging courses with multiple examples throughout.

This course is aimed at professionals involved in qualifying and validating analytical equipment and computer systems. These includes IT/IS managers and system administrators | Quality Assurance Personnel | Quality Control Professionals | Laboratory Personnel | Analytical Scientists | Validation Scientists | Regulatory Affairs |Training Departments | Documentation Departments.

Could your team benefit from this course?

We can customise this course to meet the requirements of your organisation, delivered as a classroom and/or online course.

For more information you can email us at [email protected] or call +44 (0) 203 111 7357.

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• The training course is delivered either online or in a classroom. Please check which course format you have booked.
• For live online courses, dates and times of modules are subject to change
• Please contact us for the module dates of future deliveries.
• For live online courses, module durations are approximate.