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All documents as shown here are included in the package 

 

A total of 30 SOPs are included in the package.

Two Audio Seminars are included
- Part 11 Introduction and Strategies for Implementation
- Ensuring Integrity and Security of Electronic Records for FDA Compliance

21 CFR Part 11 Compliance Package

Comply with FDA's Ongoing Part 11 Inspection Practices

- With two audio seminars and free on-line updates -

 

 

July 2016

Version 4.0 just introduced

 

With two Options for Ordering

  • CD
  • Web Download

Make Sure Your Company Complies with the FDA's ongoing Part 11 Initiative - at reasonable costs

21 CFR Part 11 is difficult to understand and even more difficult to implement, because of very high costs when implemented to the letter of the rule. Therefore not only a good understanding of the rule's spirit and details but also good knowledge of FDA's current and future interpretation, guidance documents and inspection practices are important. Doing too much is as bad as not doing enough!

This new package release guides you through the rule's requirements as well as through current FDA and industry recommendations. Following this Step-by-Step guide - along with more than 40 templates/SOPS/examples - will ensure overall cost-effective implementation.

Introducing a NEW Revision 4.0
All addressing FDA's new and ongoing Part 11 inspection and enforcement practices

  1. New audio seminar:
    Learning from Recent Warning Letters related to Part 11 and Computer Validation
  2. Updated Part 11 checklist: Reflecting FDA's ongoing interpretation of Part 11
  3. New checklist related to data integrity, Part11, Annex 11 and FDA inspections
  4. 10 Case Studies: How to Respond to Data Integrity and Security Related FDA Observations
  5. Eight new/updated SOPs: The ultimate answer to FDA's new inspection processes
  6. New URS for Electronic Signatures
  7. Updated Part 11 Compliance Master Plan
  8. Updated Step-by-Step Implementation Plan
  9. Project Schedule for Laboratory Data Integrity Implementation
  10. Updated Validation Master Plan
  11. Updated Risk Management Master Plan
  12. URS and Case studies related to electronic audit trail
  13. 30 Recent FDA Warning Letters and 483 Inspectional Observations related to Part 11 and data integrity

Package Overview

  1. Two Audio seminars:
    - Understanding FDA's 21 CFR Part 11 (basics about Part11)
    -Learning from Recent Warning Letters related to Part 11 and Computer Validation:
  2. FDA Presentations: Edwin Rivera: Data Integrity and Fraud - Another Looming Crisis?
  3. Primer: 21 CFR Part 11 - Electronic Records and Signatures: Background, requirements, new FDA interpretations and scope, implementation, applications, examples.
  4. Part 11 Compliance Master Plan: Your approach towards Part 11 compliance
  5. Risk management master plan: Implement FDA's recommended risk based approach for Part 11
  6. Implementing 21 CFR Part 11 – Electronic Records and Electronic Signatures
    - Step by Step -
  7. Part 11 project schedule with tasks and deliverables
  8. 10 Gap analyses/Checklists, e.g.,: Part 11, Using computers in FDA regulated environments, Requirement Specifications, Data Integrity and Security,
    and E-Records Retention and Retrieval
  9. Validation Examples: URS for Part 11, URS for Electronic Audit trail
  10. 31 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
  11. Templates and examples for Part 11 implementation in PowerPoint and MS Word format for easy customization
  12. 15 Case studies with graphical and tabular workflow, recommendations and documentation
  13. 80 most frequently asked question and answers related to Part 11.
  14. 40 FDA full text Warning letters and 483 inspection reports related to Part 11 and data integrity from 2006 - 2016
  15. Two years free on-line updates

Target Audience

  • 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

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.
  • Size: More than 500 pages, when printed
  • 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.

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
  • New SOPs, checklists and examples, related Intranet/Internet compliance, if necessary

Registration is automatically with each package purchase from Labcompliance

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

All in One

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

Compliance with 21 CFR Part 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 at various US and international conferences 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 scope and current thinking?
  • Which systems should comply with part 11
  • When is electronic audit trail a 'must'?
  • How to archive records: paper vs. electronic records?
  • How to deal with legacy systems?
  • How to develop and implement a gap analysis and remediation plan?
  • What is FDA's current thinking and enforcement strategy?
  • How to document business practices
  • How to document risk assessment for Part 11
  • Where to get reference material (gap analysis, examples, worksheets, SOPs) for easy implementation?

Why to go through the hassle and read several books with lots of redundant information. With this compliance package targeted to Part 11, 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) UPDATE

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 through a new guidance document. This primer will be regularly updated in response to new developments. Updates will be available through the on-line update service.

2. Two Audio seminars :

  • Understanding and Implementing FDA's 21 CFR Part 11: (243)
    Introduction and Strategies for Cost-Effective Implementation
    In a one our seminar Dr. Ludwig Huber gives an overview on the regulation and he guides the audience through a logical step-by-step process on how to implement Part 11 in a most cost-effective way.
  • Learning from Recent Warning Letters related to Part 11 and Computer Validation  (368) : NEW
    Understand new FDA inspection practices and how to avoid Inspectional observations and Part 11 / GxP violations

3. Part 11 Compliance Master Plan (M-132) UPDATE

This plan documents your company's approach and vision for Part 11. It also defines the strategies for implementation. Furthermore it defines responsibilities, e.g., for IT, QA, the project team, the team leader and for operations. Is lists required steps for implementation and documents that should be generated during the project.

4. Part 11- Step-by-Step Implementation (M-513)  UPDATE

This document guides readers through the entire process from planning through developing documentation to implementation. SOPs, forms, templates examples and other documents are directly linked to the recommended steps. This makes implementation easy.

5. Validation Master Plan (M-171) UPDATE

Validation is the key requirement on Part 11. A validation master plan is the first and most important validation document. It improves validation efficiency and ensures consistent implementation within a company. It is also an ideal document to document and demonstrate a company's approach for validation.

6. Risk Management Master Plan (M-131)  UPDATE

Risk based compliance is an FDA initiative to optimize compliance costs vs. risk of the records, or impact on product quality. The new part 11 guides has several statements, that the type of controls and their extent of implementation depends on a justified and documented risk assessment. This master plan is a framework for the development of risk assessment of electronic records. Following such a plan ensures consistent and effective implementation of Part 11 and answers the inspectors question: what is your approach for risk assessment?

7. 31 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 several example SOPs

  1. Writing and Distribution of Electronic SOPs (S-107) 
  2. Training for GxP, 21 CFR Part 11 and Computer Validation (S-125)
  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. Recording of GLP Raw Data (S-149)
  6. Recording of GMP Raw Data (S-161)
  7. Archiving of GMP Data and Other Documents (S-162)  NEW
  8. Recording of GCP Source Data (S-163)
  9. Archiving and Retrieval of GCP Data and Other Documents (S-164) NEW
  10. Testing File Integrity of E-mail Attachments (S-248)
  11. Developing an effective Supplier Program to Assists Regulated Users
    UPDATE (S-251-01)
  12. Selecting the Right Software and Equipment Supplier for Compliance
    (S-251-02)
  13. Risk Based Validation of Computer Systems (S-252) UPDATE
  14. Change Control of Software and Computer Systems UPDATE (S-262)
  15. Validation of Commercial Off-the-shelf Computer Systems (S-271)
  16. Auditing Computer Systems (s-272)
  17. Auditing Laboratory Computer Systems for Data Integrity (S-272-02) NEW
  18. Auditing of Suppliers of Software and Computer Systems (S-273)
  19. Quality Assessment of Software and Computer System Suppliers (S-274)
  20. Retention and Archiving of Electronic Records (S-315)  UPDATE
  21. Scanning of Paper Documents for FDA Compliant Archiving (S-316)
  22. Data Back up and Restore (S-317)
  23. Handling Contingency Situations for Computer Systems (S-318)
  24. Disaster Recovery of Computer Systems (S-319)
  25. Access Rights to Computer Systems and Data (S-320)
  26. Electronic Audit Trail
    Specifications, Implementation and Validation
    (S-322)
  27. Review of Electronic Audit Trail (S-323)
  28. Integrity and Security of Electronic Records UPDATE (S-324)
  29. Using Electronic Signatures in FDA Regulated Environments (S-325)  NEW
  30. Security and Integrity of Electronic Laboratory Data UPDATE (S-551)
  31. Manual Reintegration of Chromatographic Peaks NEW (S-552)

8. User Requirements for Part 11 (E-307)  UPDATE

Requirement specification should be the first document to implement Part 11 for new and existing computer systems. This document lists software and functions that are required for Part 11

9. Requirement Specifications for Electronic Audit Trail (E-258)

Electronic audit trail is an important software requirement and should be thoroughly specified

10. User Requirement Specifications for Electronic Signatures (E-307-01) UPDATE

Part 11 has very specific requirements for executing electronic signatures. They should be included in the URS for software used for e-signatures

10. Gap Analysis/Check Lists

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

  1. Security and Integrity of Electronic Records (E-148-02)
  2. Security and Integrity of Electronic Data in Laboratories (E-148-03) NEW
  3. What Regulated Users should expect from Suppliers of Equipment and Computer Systems (E-148-06)
  4. What Equipment and Computer System Suppliers should offer to Regulated Users (E-148-07) UPDATE
  5. EU GMP Annex 11: Version 2011 (E-151)
  6. Electronic audit trail (E-152)
  7. Using Electronic Signatures in Regulated Environments (E-152-01) NEW
  8. FDA Record Retention and Retrieval (E-155)
  9. Using Computers in FDA regulated environments (E-161)
  10. 21 CFR Part 11 Compliance (E-168)  UPDATE
  11. Software/computer System Vendor Assessment (E-321)

11. Project Schedules for Part 11 (E-227) (NEW)

Once the gaps have been identified a project schedule should be developed for Part 11 implementation. This example schedule has project items and columns for deliverables, owners and timing.

12. Validation Templates and Example

Templates and examples help implement Part 11 controls and processes effectively  throughout your organization. The Package includes templates/examples for

  1. Supplier Quality Agreement (E-149-01) NEW
  2. Complete Validation Example: Win MD5 Software (E-305)
  3. Testing of Authorized System Access (E-362)
  4. Test Cases for Electronic Audit Trail (E-364)

13. Case Studies

Case studies help to systematically identify which system requires which Part 11 functionality to implement Part 11 for specific systems. 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 is included is a Word document with 10 case studies consisting of decision trees to identify and document Part 11 requirements. And there are case studies on how

  1. 15 Part 11 Case Studies (Word) (E-411)
  2. 15 Part 11 Case Studies (PowerPoint) (E-411)
  3. 10 Case Studies - Electronic Audit trail (E-415)
  4. How to Respond to Part11 Related 483's and Warning Letters (E-425) UPDATE
  5. How to Avoid Part11 Related 483's and Warning Letters (E-426) UPDATE

14. 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. Letter to the FDA about the Intend Using E-Signatures (K-1412) (UPDATE)
  3. Documentation of Part 11 Training with Accountability for E-Signatures (K-1413)
  4. Part 11 Vision (K-1415)
  5. Part 11 Objectives (K-1416)
  6. Part 11 Strategy (K-1417)
  7. Computer System Documentation for Part 11 (K-1418)
  8. Optimizing Validation efforts vs. Costs and Risks (K-4031)
  9. Risk Categories Based on Compliance Impact (K-4033)
  10. Risk Categories Based on Business Impact (K-4034)

15. Reference Papers

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

  1. Risk Based Validation of Commercial Off-the-shelf Computer System
  2. Implementing Part 11 – Part 4: Data Migration and Long Term Archiving for Ready Retrieval
  3. Impact of Part 11 on Chromatographic Data System

16. Regulatory References
These documents have 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)

17. FDA Inspectional Observations and Warning Letters

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 2007-2016. This section will be regularly updated. Updates are available through the on-line update service.

18. 80+ Most Frequently Asked Questions and Answers

This section includes more than 80 questions and answers we received during our audio seminars, conference workshops and through e-mail.

19. 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