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 128
Electronic Raw Data in FDA Regulated
Definition - Maintenance - Archiving -
The FDA defines raw data in 21 CFR Part 58 as: "Any laboratory worksheets,
records, memoranda, notes, or exact copies thereof, that are the result of
original observations ... and are necessary for the reconstruction and
evaluation a study. In the event that exact transcripts of raw data have been
prepared (e.g., tapes which have been transcribed verbatim, dated, and verified
accurate by signature), the exact copy or exact transcript may be substituted
for the original source as raw data". The rule mentioned computer print-outs and
magnetic media as examples. With the early interpretation of 21 CFR Part 11 raw
data generated by a computer have more or less been defined as the original
digital data captured by a computer. Original data together with meta data were
expected to be retained for the entire life of record retention as required by
the predicate rule. With FDA's new interpretation this has changed but the FDA
can still ask for such original electronic records during inspections. So the
industry is more unsure than ever on what to do.
Key Questions related to raw data are:
- What are FDA requirements and inspection practices for raw
data in GLP/GCP/GMP?
- What exactly are raw data: original electronic data, first
human readable data, computerprint-outs?
- Which data should be retained and archived?
- Can I delete the electronic records after I have printed and
signed the electronic records?
- For how long should raw data be retained?
- In which form should raw data be retained?
- How can I demonstrate integrity of raw data?
- How important is risk assessment for my decision?
- We move to a new computer systems that can not handle old
data - What to do?
- I transcribe data from paper into an data base. Can I scrap
- I scan paper print-outs and store PDF files in a data base -
can I delete the paper records?
- Should I be able to reprocess the raw data and if so for how
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 and examples.
After the seminar, an extensive list of reference material like
SOPs, worksheets, templates and examples will help immediate and
cost effective implementation.
During the interactive presentation you learn about:
- FDA Requirements for raw data and meta data
- FDA Inspection and enforcement practices
- Recommendations from industry task forces: GAMP/ISPE guides
- Definition of raw data: original records vs. standard
electronic formats, paper print-outs
- Ensure and demonstrate integrity of raw data
- The importance of risk assessment for the management of raw
- Electronic record maintenance during archiving period
- Software to manage and archive raw data and other electronic
- Data migration to new systems
- Developing a procedure for consistent raw data management
- Examples from laboratories, offices and manufacturing
And for easy and instant implementation:
download 10+ documents from special seminar website
- SOP: Retention and Archiving of Electronic Records
- SOP: Validation of Electronic Document Management Systems
- SOP: Validation of Commercial Off-the-Shelf System
- SOP: Change Control of Software and Computer Systems
- SOP: 21 CFR Part11 - Scope and Controls
- Checklist: Using computers in FDA regulated environments
- Worksheet: FDA Record Retention Requirements
- Regulatory reference documents:
- FDA Drug cGMP: Requirements for Laboratory Records
- FDA Drug cGMP: Requirements for Manufacturing Records
- Literature Reference papers. I
- Implementing 21 CFR Part 11 - Data Migration and Long Term
Archiving for Ready Retrieval
- Risk-based Validation of Commercial Off-the-Shelf Computer
- Warning letters and Inspectional observations related to raw
- FDA guidance documents and predicate rules
Who should attend?
- Record manager
- Documentation professionals
- QA managers and personnel
- Analysts and lab managers
- Validation specialists
- Regulatory affairs
- Human resources (HR) managers and staff
- Training departments
How to order
Replaced by the more recent seminar
Electronic Raw Data in Regulated
Definition, generation and
archiving for FDA Part 11, HIPAA and SOX compliance
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,