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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 128

Electronic Raw Data in FDA Regulated Environments

Definition - Maintenance - Archiving - Retrieval


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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 the paper?
  • 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 long

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 data
  • Electronic record maintenance during archiving period
  • Software to manage and archive raw data and other electronic records
  • 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 Systems
  • Warning letters and Inspectional observations related to raw data.
  • 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
  • Consultants

How to order

Replaced by the more recent seminar

Electronic Raw Data in Regulated Environments

Definition, generation and archiving for FDA Part 11, HIPAA and SOX compliance

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.