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All documents as shown here are included in the package 

A total of 25 SOPs are included in the package.

The Audio Seminar 
- Ensuring Integrity and Security of Electronic Records for FDA Compliance is included in the package

Laboratory Data Integrity Package

 With controls and examples for FDA and EU compliance

Testimonials

So far we have received very positive feedback from customers of Ludwig Huber's documents and seminars on data integrity and FDA Part 11 inspections, to see the feedback click here.

 

With two Options for Ordering

  • CD
  • Web Download

 

Make Sure Your Company Complies with FDA's and EMA's ongoing lab data integrity inspections

FDA has found and reported about multiple cases where companies manipulated laboratory records to bring out-of-specification results into specifications.  Since then FDA inspectors have focused during GLP, GCP and GMP  inspections on integrity of 'complete' laboratory records. FDA has trained inspectors to identify data falsification and recommended the same to industry QA departments and auditors. Just in the last three years FDA issued over 30 warning letters and 483 form inspectional observations related to "inadequate" laboratories records. In several instances FDA initiated other more severe enforcement actions such as shipment stops and import alerts. The industry is unsure how to comply with FDA and EMA inspection requirements. 

This new package guides you through the detailed requirements . Using this Step-by-Step guide - along with more than 40 templates/SOPS/examples - will ensure overall cost-effective implementation.

Package Overview

All optimized to address FDA's and EMA's new and ongoing laboratory integrity related  regulations, guidelines and inspection and enforcement practices

  1. Primer: 21 CFR Part 11 - Electronic Records and Signatures: Background, requirements, new FDA interpretations and scope, implementation, applications, examples.
  2. Audio seminar:
    - How to Ensure Part 11 Compliant Integrity of Laboratory Data -
    Comply with new FDA inspection practices and EU Annex 11 requirement
  3. 25 SOPs for risk assessment of computer systems, for maintenance and archiving electronic records, scanning of paper records for FDA compliant archiving, validation of COTS computer systems, part 11 application and controls, for people qualification, for auditing computer systems and for assessment of suppliers of computer systems, ensuring e-records integrity and security, using electronic signatures
  4. User Requirements: Include lists of software functions that are necessary to implement data integrity projects
  5. Three Gap analyses/Checklists: Data Integrity and Security, Electronic audit trail and E-Records Retention and Retrieval
  6. Project schedule : Laboratory data integrity implementation with tasks, owners and deliverables
  7. Case studies for Part 11 implementation in PowerPoint and MS Word format for easy customization. Also includes case studies on how to avoid or respond to data integrity related 483s and warning letters
  8. Forms for consistent and effective implementation and documentation
  9. Reference papers with in-depth information on selected topics
  10. Regulatory references: the authentic sources for defining complete records
  11. FDA Presentations to better understand the view of FDA officials
  12. Direct links to the key official regulations and guidelines for easier searching
  13. 30+ most frequently asked question and answers related to data integrity.
  14. 20+ FDA full text Warning letters and 483 inspection reports related to Part 11 and Data Integrity from 2006 - 2015: See what FDA inspectors look for and learn how to avoid mistakes others made
  15. Two years free on-line updates to easily follow FDA ever changing inspection practices

Target Audience by function

  • QA managers and personnel
  • IT/IS managers and personnel
  • Operations managers and personnel
  • Lab managers and personnel
  • Regulatory affairs
  • Analytical scientists
  • Validation specialists
  • Training departments
  • Documentation departments
  • Consultants

Target Audience by Industry

  • Pharmaceutical development and manufacturing
  • API - Drug Substances
  • Medical devices
  • All laboratories performing clinical studies
  • Contract laboratories
  • Software, system and service providers
  • Consulting firms

Format/Price/Ordering

  • Format and Pricing
    - 1) CD
     for $699.-
    - 2) Web download for $
    649.-
    Prices include shipping and two years on-line updates
    VAT will be added for EU countries.
  • Availability: Worldwide, shipment within one working day after order entry and payment has been received
  • Ordering: (SSL secured, recommended for payment by credit card)
    - Electronically
    from this this web site (SSL secured)
    - Regular mail or fax using the form in PDF
    or MS Word format

Free Online Update

On-line updates - keeps you on top of ever changing regulatory requirements

Regulations are quite dynamic especially when new technology is involved. Regulatory agencies and industry task forces frequently release or update regulations or guidance documents and inspection and enforcement practices change even more frequently.

A book can give the background, the fundamentals and an overview on regulations and inspection practices at a particular point in time - but updates reflecting on-going changes are practically limited to a 3 to 5 year time frame.

The Internet with it's instant publication power can give this update on a much more frequent basis, but is not so popular to learn the fundamentals. The real solution is a combination of both: get the start up package for the fundamentals and use the Internet for the updates. That's why we offers two year free on-line updates with the purchase of the package.

Updates include:

  • New regulations related to Internet, Intranet, Networks, and computer validation
  • New guidelines from agencies and industry task forces
  • Interpretations what the new regulations/guidance mean for e-records/signatures and how to respond
  • On-going FDA and EU inspection and enforcement practices
  • New SOPs, checklists and examples, related laboratory data integrity compliance, if necessary

Registration is automatically with each package purchase from Labcompliance

Click here to go to the update site (requires pass word protected access information)

All in One

All in one - makes your work efficient and keeps your budget under control

Compliance with 21 CFR Part 11 and Annex 11 can be a complex task. This gets even more complex and even confusing when information is obtained from different sources. Frequently they give a high level overview talking about generic requirements but none gives a full picture and details that are required for quick implementation in laboratories.

This package is a single source covering all aspects. It is written by a single author who has more than 20 years practical experience with FDA and international regulations and understands Part 11 and software and computer validation from ground.

The author has been ranked as number one presenter by various US and international conference providers and the package answers all questions typically raised at these conferences:

  • What are the key requirements?
  • What are the issues?
  • What is FDA's new inspection approach and current thinking on data integrity?
  • Are there any different requirements for FDA and EMA?
  • Which lab systems are of highest concern for data integrity
  • When is electronic audit trail a 'must'?
  • What a practical solutions for reviewing audit trails?
  • What is considered a complete laboratory record?
  • When does audit trail start - at the time of data entry or after changes?
  • How to archive records: paper vs. electronic records?
  • Under which circumstances are computer print-outs sufficient, rather that keeping all electronic records? 
  • How to deal with legacy systems?
  • How to develop and implement a gap analysis and remediation plan?
  • How to document and defend data integrity compliance?
  • How important is risk assessment for data integrity?
  • Where to get reference material (gap analysis, examples, worksheets, SOPs) for easy implementation?

Why to go through the hassle and read several articles with lots of redundant information. With this compliance package targeted to lab data integrity, you get all answers in one consolidated set of documents. This not only saves time, it's also cost effective. And as requirements change, you get the answers through the on-line update service.

Detailed Contents

1. Primer: 21 CFR Part 11 - Electronic Records & Signatures (M-214)

This gives an overview on the background, history and all requirements. Readers are also informed on industry issues and how the FDA responded to them. This primer has been and will be regularly updated in response to new guidance developments and inspections and enforcement practices. Updates will be available through the on-line update service.

2. Audio seminar:

How to Ensure Part 11 Compliant Integrity of Laboratory Data (314) :
Comply with new FDA inspection practices and EU-PIC/S Annex 11 requirements

3. Standard Operating Procedures (SOPs)

In FDA regulated environments routine operations should follow written procedures. They help to implement processes and and technical controls in a consistent manner. The Part 11 Compliance Package includes 25 example SOPs

  1. Writing and Distribution of Electronic SOPs (S-107) 
  2. Training on implementing and documenting laboratory data integrity (S-125-02)
  3. Risk Assessment for Systems Used in GxP Environments.
    This to identify risk levels for computer Systems (S-134)
  4. Part 11 Scope and Controls (S-137)
    Used to define, justify and document requirements for Part 11
  5. FDA Inspections: Preparation, Conduct and Follow-up (S-141)
  6. Responding to FDA 483 Inspectional Observations (S-143)
  7. Responding to FDA Warning Letters (S-144)
  8. Recording of GLP Raw Data (S-149)
  9. Recording of GMP Raw Data (S-161)
  10. Archiving of GMP Data and Other Documents (S-162)  
  11. Recording of GCP Source Data (S-163)
  12. Archiving and Retrieval of GCP Data and Other Documents (S-164)
  13. Testing File Integrity of E-mail Attachments (S-248)
  14. Auditing Laboratory Computer Systems for Data Integrity (S-272-02)
  15. Retention and Archiving of Electronic Records (S-315)  
  16. Scanning of Paper Documents for FDA Compliant Archiving (S-316)
  17. Data Back up and Restore (S-317)
  18. Access Rights to Computer Systems and Data (S-320)
  19. Electronic Audit Trail. Specifications, Implementation and Validation (S-322)
  20. Review of Electronic Audit Trail (S-323)
  21. Using Electronic Signatures in FDA Regulated Environments (S-325) 
  22. Identification and Control of Laboratory Records (S-526)
  23. Laboratory Failure Investigations (s-530)
  24. Security and Integrity of Electronic Laboratory Data (S-551)
  25. Reintegration of Chromatographic Peaks (S-552)

4. User Requirements

Software requirement specifications should be the first documents to implement laboratory data integrity projects for new and existing computer systems. Three documents list software functions that are required to ensure data integrity, electronic audit trail and electronic signatures.

  1. Requirement Specifications for Electronic Audit Trail (E-258)
  2. User Requirement Specifications for Electronic Signatures (E-307-01)
  3. Requirements to Ensure Integrity of Laboratory Data (307-02)

5. Gap Analysis/Check Lists

Gap analyses and checklists are key to identify missing procedures and technical controls to implement part 11. The Package includes six gap analyses

  1. Security and Integrity of Electronic Data in Laboratories (E-148-03)
  2. EU/PICS GMP Annex 11: Version 2011 (E-151)
  3. Electronic audit trail (E-152)
  4. Using Electronic Signatures in Regulated Environments (E-152-01)
  5. FDA Record Retention and Retrieval (E-155)
  6. 21 CFR Part 11 Compliance (E-168) 

6. Project Schedule (E-228)

Once the gaps have been identified a project schedule should be developed for data integrity implementation. This example schedule has project items and columns for deliverables, owners and timing.

7. Case Studies

Case studies help to systematically identify which system requires which Part 11 functionality. The package includes 15 case studies with visual representations, business practices and recommendations which Part 11 requirements should be implemented for each system.  The information is provided as PowerPoint file for convenient training and as Word file. Also included is a Word document with 10 case studies consisting of decision trees to identify and document Part 11 requirements. And there are six case studies on how to avoid or respond to data integrity related warning letters

  1. Part 11 Case Studies with focus on data integrity (Word) (E-411)
  2. Part 11 Case Studies (PowerPoint) with focus on data integrity (E-411)
  3. Case Studies - Electronic Audit trail (E-415)
  4. How to Respond to Data Integrity Related 483's
    and Warning Letters (E-425-02)
  5. How to Avoid Data Integrity Related 483's and Warning Letters (E-426-02)

8. Forms

Forms help implementing Part 11 controls and processes consistently throughout your organization. The Package includes forms for

  1. Project Team Part 11 (K-1411)
  2. Lettter to the FDA about using e-Signatures (K-1412)
  3. Documentation of Part 11 Training with Accountability for E-Signatures (K-1413)

9. Reference Papers

Reference papers give an in depth information on selected topics. The package includes reference papers on

  1. Impact of Part 11 on Chromatographic Data System (a-184)
  2. Implementing 21CFR Part 11 - Electronic Signatures and Records in Analytical Laboratories - Part 3. Ensuring Data Integrity of Electronic Records (a-193)
  3. Implementing 21CFR Part 11 - Electronic Signatures and Records in Analytical Laboratories – Part 4: Data Migration and Long Term Archiving for Ready Retrieval (a-194)

10. Regulatory References
These documents have authentic information what records are required by different regulations and applications

  1. FDA Drug cGMP  Requirements for Laboratory Records (R-118)
  2. FDA Drug cGMP  Requirements for Manufacturing Records (R-119)
  3. FDA GCP Regulations: Requirements for Clinical Trial Records (R-121)

11. Direct links to the key official regulations and guidelines for easier searching

  1. FDA 21 CFR Part 11: Electronic Records, Electronic Signatures, 1997
  2. EU/PICS Annex 11 to GMP: Computerized Systems
  3. Link to FDA CGMP questions&answers with Statements about print-outs

12. FDA Presentations to better understand the view of FDA officials

  1. Edwin Rivera: Data Integrity and Fraud – Another Looming Crisis?
  2. Steve Wilson FDA Regulatory Perspective an Data integrity

13. 30 Most frequently asked Question and answers related to data integrity

This section includes more than 30 questions and answers we received on data integrity during our audio seminars, conference workshops and through e-mail.

14. FDA Inspectional Observations and Warning Letters Related to Data Integrity and other Part 11 Requirements

Regulations and guidelines are fine but the real answer on what's going on during inspections can be found in FDA inspection reports, warning letters and inspectional observations.

The package includes more than 30 of such documents published by the FDA from 2007-2014. This section will be regularly updated. Updates are available through the on-line update service.

15 On-line Update Support

Subscribers of the package get two years on-line updates through a password protected website. This includes regulatory updates and other new documents such as SOPs, examples and templates.

 

The author

Picture of Ludwig Huber

The author, Dr. Ludwig Huber, is an international expert on laboratory compliance and quality standards. He has been responsible for the compliance and quality standards program at Hewlett Packard and Agilent Technologies for more than 20 years. He serves as a consultant for the industry and agencies on local and international compliance and quality issues. He has been a member of the US PDA task force on 21 CFR Part11 and of the GAMP Special Interest Group for Laboratory Computer Systems. He is also was/is on the advisory board for the European Compliance Academy and IVT's GxP Journals. Several of his previous books have been bestsellers and several times he has been ranked as number one presenter at various international conferences. For publications, presentations and other achievements, click here

Dr. Ludwig Huber in Panel Discussions with FDA Officials

George Smith, FDA's national Part11 expert, at a panel discussion with Ludwig Huber during an IVT conference

Smith and Huber discussed and answered questions about computer system validation and e-records.
Ludwig Huber (right) and John Murray, FDA's Computer Validation Expert, (left), speaking at the IVT Computer System Validation Conference.
Mr. Murray explined FDA'snext steps for Part 11


Ludwig Huber (right) in a panel discussion with FDA inspectors and directors:
 Dr. Robert C. Horan, B Erik Henrikson,Joseph Famulare,  and Nicholas Buhay,

Testimonials/References

 

 

The Feedbacks on the seminar has been received by e-mails. Labcompliance has permission to use the testimonials as references. Original e-mails are stored in the Labcompliance archive.

  1. Seminar: Understanding and Preparing for FDA's New Part 11 Inspection Program
    Feedback: The seminar did exceed my expectations.  The seminar is very useful as it contains a lot of information.
    Mr. Lucian Hirtie,  QS Manager, Labstat International ULC, Canada
    (Ref T-1082).
  2. Seminar: Ensuring Integrity and Security of Electronic Records for FDA Compliance
    Feedback: The seminar did exceed my expectations.  The information is very complete. Dr Huber knows the subject very well. Excellent presentation
    Mr. Han Seng Tay Manager GGB,  Health Sciences Authority, Singapore, USA
    (Ref T-1
    123)
  3. Seminar: Understanding and Preparing for FDA's New Part 11 Inspection Program
    Feedback: The seminar did exceed my expectations.  Very informative presentation, and clearly presented . Dr Huber does an excellent presentation, well developed, and very informative, as usual.
    Mr. John Egoville,  Senior Compliance Auditor,  Computer Validation Group, TEVA Pharmaceuticals, USA
    (Ref T-1081)
  4. Seminar: Recent Warning Letters and 483's Related to Computer Validation and Part 11
    Feedback:
    The seminar did exceed my expectations.  The presentation contains much more pertinent information than I had expected.
    Mr. Joachim Fehr, Stryker, CSV Specialist QA, Germany
    (Ref T-1076).
  5. Seminar: FDA's New Enforcement of 21 CFR Part 11
    Feedback:
    The seminar did meet my expectations.  I always expect a wonderful seminar from Dr. Huber, and my expectations were once again met. A great time saver for me as I do not have time to look up recent 483s relating to Part 11 -- worth the time and cost.
    Ms. Diana Mayes, Manager of ABC Laboratories, USA
    (Ref T-1077)
  6. Seminar: FDA's New Enforcement of 21 CFR Part 11
    Feedback:
    The seminar exceed my expectations.  Webinar was very informative to our current practice and will help us focus and stream line our process. I would recommend this seminar to everyone having the same responsibilities.
    Ms. Mike Robertson, QA Engineer at Energizer, USA
    (Ref T-1078).