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Labcompliance On-line Audio Seminar

This seminar has been recorded and is available on CD and for instant download. All reference material as listed below and more is available on a special seminar website. The website is regularly updated with most recent information. In case there are questions related to the topic, they can be submitted through a web form and will be answered by the speaker. For ordering info click here.

On-line Audio Seminar 126

User Requirement Specifications for Software and Computer Systems

Strategies for Development, Documentation and Updates

Get 10+ Documents To Do it Right The First Time


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User Requirement Specifications (URS) are the most important validation deliverables for software and computer systems. No or inadequate URS are frequently cited as deviations in FDA inspections. Errors in this early validation phase can have a tremendous impact on overall validation and operation costs. There are no specific guidelines for the development of such documents, so validation professionals are unsure how to proceed.

Frequent questions are

  • What are the regulatory requirements
  • What is the difference between user requirements, functional and system requirements.
  • Can I combine user requirements and functional requirements in a single document?
  • How detailed should URS be?
  • How should I document URS, e.g., in which format?
  • How to prioritize requirements?
  • Who is responsible for development URS?
  • What are good and what are bad examples for URS?
  • Can we change URS and which process should we follow?
  • How to link URS to testing?
  • Is there software available to track URS and traceability matrix

How does the audio seminar help:

Questions will be answered by Dr. Ludwig Huber in a new interactive audio seminar. During the seminar strategies and procedures will be presented on how to develop, document, maintain and update User Requirements. An extensive list of reference material like SOPs, templates and examples will help immediate and cost effective implementation.

During the interactive presentation you learn about:

  • Regulatory requirements and industry practices
  • Relation of URS with other specifications: e.g., functional specifications, design specifications
  • Responsibilities for development
  • Procedure for development
  • Attributes of URS
  • Contents of URS document
  • Structure of URS document
  • Level of detail of specifications
  • Organizing and managing the review meeting
  • Updating URS
  • Good and bad examples

Get 10+ Documents To Do it Right The First Time:
download from special seminar website

  • SOPs:
    - Development of Requirement Specifications for Computer Systems
    - Change Control of Software and Computer systems
    - Validation of Commercial Off the Shelf Systems
    - Validation of Spreadsheet Application
  • Gap analysis/checklists:
    - User Requirement Specifications
    - Using Computers in FDA Regulated Environments
  • Templates/examples
    - URS for Chromatographic data systems
    - URS for a Document Management System
    - Requirement Specifications for Electronic Audit Trail
    - URS for Spreadsheet Applications
    - URS for Part 11
    - 20 Good/bad URS Examples and Reasons Why
  • Warning letters and Inspectional observations related to software and computer validation
  • FDA/EU Guidance documents related to software and computer validation

Who should attend?

  • System owners
  • Software developers
  • IT managers and system administrators
  • QA managers and personnel
  • Analysts and lab managers
  • Validation professionals
  • Training departments
  • Documentation department
  • Consultants

How to order

Replaced by the more recent seminar

Requirement Management for Equipment and Computer Systems

Strategies for Development, Documentation and Updating Requirement Specifications

Click here

About audio seminars


Online audio seminars are presented over the phone. During the live presentation attendees can:

  1. Study the printed slide material
  2. Watch the slides on a computer
  3. Watch the slides on a video screen in a seminar room
  4. Ask questions through email and web form

About Dr. Ludwig Huber

Dr. Ludwig Huber is the editor and author of Labcompliance. He has been conducting over 300 web and audio or video based seminars since 15 years and and he has given multiple presentations mainly on GLP/GMP, 21 CFR Part 11 and Validation around the world. This included seminars, workshops and presentations for the US FDA, SFDA, KFDA, HSA, ISPE, PDA, PIC/S and several national health agencies.

Dr. Ludwig Huber is a frequent presenter at IVT conferences and has been awarded as the 'Presenter of the Year' out of 170 speakers. This photo is from IVT's conference on Network Qualification with Ludwig Huber as plenary speaker.

Dr. Huber has published several books related to validation and compliance, for example: Validation of Computerized Analytical and Networked Systems. He was or still is a member of several committees, e.g., of the GAMP® Special interest group (SIG) on Laboratory Computers, PDA Part 11 task force, IVT task force on network infrastructure qualification and the European Compliance Academy. He frequently visited FDA in Rockville, VA, and participated in panel discussions with FDA professionals. For feedback from attendees of seminars and  for other information on Dr. Ludwig Huber, click here.