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 162
Validation and Use of Excel® Spreadsheets
in Regulated Environments
Comply with GxPs, Part11, HIPAA, SOX and
Excel® Applications are widely used in laboratories, offices and manufacturing
e.g., for data capture, data manipulation and report generation. Regulations
such as HIPAA, Sarbanes Oxley Act and FDA's GxP and 21 CFR Part 11 require users
of software and computer systems to demonstrate and document data accuracy,
integrity and confidentiality.
Out-of-the box Excel® has not been designed for regulated environments. However,
with a good knowledge of Excel® capabilities combined with good procedures and
practices on how to validate and use Excel® requirements can be met. For
example, the FDA is widely using Excel® and complies with its own regulations.
The question is how to do this.
Questions related to Excel® are:
- What exactly is required by the regulations?
- What are the limitations of 'out of the box Excel'?
- What does GAMP suggest for Spreadsheets?
- How to overcome Excel® limitations for Part 11 and other
- What should we validate?
- Should we test standard Excel® functions?
- Should we validate ad 'hoc' or 'one time use' Excel®
- We use Excel templates as calculator, do we need to keep
- What and how much should we document?
- When can we delete e-records and when should we keep them?
- How does the FDA comply with their own their own
- How to apply risk based validation to Excel spreadsheets?
How does the audio seminar help:
Answers will be presented by Dr. Ludwig Huber in a new
interactive audio seminar. During the seminar, the speaker will
present strategies and give practical recommendations. After the
seminar, an extensive list of reference material like SOPs,
templates and examples will help immediate and cost effective
During the interactive presentation you learn about:
- Regulatory requirements for spreadsheets; FDA Part 11, GxP,
- Typical compliance problems with spreadsheets
- Recommendations from GAMP
- Recommendations from FDA's two Information bulletins for:
single users and multiple users of spreadsheet applications.
- How to design spreadsheets for compliance.
- How to ensure and validate spreadsheet integrity.
- When, what and how much to test?
- Validation of standard Excel functions?
- How to apply risk based validation to spreadsheet
- Validation of 'ad hoc' spreadsheet applications.
- How to document planning, specifications, installation,
testing and changes
- Examples from manufacturing, laboratories and offices
And for easy and instant implementation:
download 10+ documents from special seminar website
Two FDA Laboratory Information Bulletins (not available from
FDA's public website).:
- Spreadsheet design and validation for the multi-user and single
- Validation of spreadsheet applications
- Development and use of spreadsheets in regulated environments
- Change control of software and computer systems
- Gap analysis for Macros and Spreadsheet applications
- Spreadsheet validation project schedule
- Requirement specification
- Installation documentation
- Traceability matrix
- Protocols for functional testing
- Summary test sheet
- Article (Published in Biopharm): Using Macros and
Spreadsheets in Regulated Environment
- Software and validation package: File integrity check with
MD5 Hash Calculations
- FDA 483 form inspectional observations, establishment
inspection reports and several warning letters with deviations
related to Excel
- And more....
Who should attend?
- All developers and users of spreadsheet applications
- Validation specialists
- QA managers and personnel
- Production and lab managers
- Regulatory affairs
- Training department
- Documentation department
How to order
Replaced by the more recent seminar
Use of Excel® Spreadsheets in Regulated Environments
Comply with GxPs,
Part11, HIPAA, SOX and other regulations.
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,