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
On-line Audio Seminar 126
User Requirement Specifications for
Software and Computer Systems
Strategies for Development, Documentation
Get 10+ Documents To Do it Right The First
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
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
- 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
- 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
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
How to order
Replaced by the more recent seminar
Management for Equipment and Computer Systems
Development, Documentation and Updating Requirement
About audio seminars
Online audio seminars are presented over the
phone. During the live presentation attendees can:
- Study the printed slide material
- Watch the slides on a computer
- Watch the slides on a video screen in a seminar room
- 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
||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,