21 CFR Part 11 Compliance Package

Comply with FDA's New Inspection Practices

With audio seminars and free on-line updates

 

 

Version 2 just introduced

 

Now with two Options for Ordering

• CD/Binder
• Web Download

Make Sure Your Company Complies with the New FDA 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 and guidance documents is important. Doing too much is as bad as not doing enough!

This new package guides you through the rule's requirements as well as through current FDA and industry recommendations. Using this Step-by-Step guide - along with more than 30 templates/SOPS/examples - will ensure overall cost-effective implementation.

Introducing a NEW Revision 2.00

1. Presentation from FDA's Georg Smith: Past, Present and Where we are Going
2. New audio seminar:
   Understanding FDA's 21 CFR Part 11
   Introduction and Strategies and Tools for Implementation
3. New audio seminar
   How to Prepare Your Organization for the 'New' Part 11:
   Learn What's Coming and How to Implement
4. New Part11 checklist: Reflecting FDA's interpretation and anticipated changes in the expected revised version of Part 11
5. 15 proven Case Studies on how to implement the new scope and anticipated changes with the NEW Part11
6. Updated SOP: Part11 Scope and Controls
7. New FDA Industry Guidance: Using Electronic Means to Distribute Certain Product Information
8. 8 Forms for consistent implementation
9. URS and Case studies related to electronic audit trail
10. 25 recent FDA Warning Letters and 483 Inspectional Observations related to Part 11

Package Overview

1. Two new Audio seminars:
   - Understanding FDA's 21 CFR Part 11 (basics about Part11)
   - How to Prepare Your Organization for the 'New' Part 11:
      (Learn What's Coming and How to Implement)
2. FDA Presentations:  George Smith: CDER Part 11 Inspection Assignments
   FDA's New Inspection Program 2010/2011)
3. FDA Presentations: Edwin Rivera: Data Integrity and Fraud - Another Looming Crisis?
4. Primer: 21 CFR Part 11 - Electronic Records and Signatures: Background, requirements, new FDA interpretations and scope, implementation, applications, examples.
5. Part 11 Compliance Master Plan
6. Risk management master plan: Implement FDA's recommended risk based approach for Part 11
7. Implementing 21 CFR Part 11 – Electronic Records and Electronic Signatures
   - Step by Step -
8. Part 11 project schedule with tasks and deliverables
9. Three Gap analysis/Checklist: Part 11, Using computers in FDA regulated environments, Requirement Specifications
10. Validation Examples: URS for Part 11, URS for Electronic Audit trail,
11. 20 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.
12. Templates and examples for part 11 implementation in PowerPoint or MS Word format for easy customization
13. 15 Case studies with graphical and tabular workflow, recommendations and documentation
14. 80 most frequently asked question and answers related to Part 11.
15. 25 FDA Warning letters and 483 inspection reports related to Part 11 from 2006 - 2010
16. FDA Regulations and Part 11 Guidance
17. 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
• Consultants

Format/Price/Ordering

• Format and Pricing
  - 1) Binder with CD, for $649.-
  - 2) Web download for $599.-
  Prices include shipping and two years on-line updates
  VAT will be added for EU countries.
• Size: More than 1000 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 with FDA and international regulations and understands software and computer validation from ground.

The author has been ranked as number one presenter at various 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 laboratories, you get all answers in one. 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

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 :

• 21 CFR Part 11 - Electronic Records & Signatures,
  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.
  
  How to Prepare Your Organization for the 'New' Part 11:
  Learn What's Coming and How to Implement
  

3. Part 11 Compliance Master Plan

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

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

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

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, the 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. User Requirements for Part 11

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

8. Requirement Specifications for Electronic Audit Trail

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

9. 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. Using Computers in FDA regulated environments (E-161)
2. 21 CFR Part 11 Compliance (E-168)
3. Electronic audit trail (E-152)
4. Software/computer System Vendor Assessment (E-321)

10. Project Schedule

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.

11. 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. Training for GxP, 21 CFR Part 11 and Computer Validation (S-125)
2. Risk Assessment for Systems Used in GxP Environments.
   This to identify risk levels for computer Systems (S-134)
3. Part 11 Scope and Controls (S-137)
   Used to define, justify and document requirements for Part 11
4. Recording of GLP Raw Data (S-149)
5. Recording of GMP Raw Data (S-161)
6. Recording of GCP Source Data (S-163)
7. Testing File Integrity of E-mail Attachments (S-248)
8. Risk Based Validation of Computer Systems (S-252)
9. Change Control of Software and Computer Systems (S-262)
10. Validation of Commercial Off-the-shelf Computer Systems (S-271)
11. Auditing Computer Systems (s-272)
12. Quality Assessment of Software and Computer System Suppliers (S-273)
13. Assessment of Suppliers of Software and Computer Systems (S-274)
14. Retention and Archiving of Electronic Records (S-315)
15. Scanning of Paper Documents for FDA Compliant Archiving (S-316)
16. Data Back up and Restore (S-317)
17. Handling Contingency Situations for Computer Systems (S-318)
18. Disaster Recovery of Computer Systems (S-319)
19. Access Rights to Computer Systems and Data (S-320)
20. Electronic Audit Trail
    Specifications, Implementation and Validation

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. Project Schedule - Part 11 Implementation (E-227)
2. Requirement Specifications for Electronic Audit Trail (E-258)
3. Complete Validation Example: Win MD5 Software (E-305)
4. User Requirements for Part 11 (E-307)
5. Testing of Authorized System Access (E-362)
6. Test Cases for Electronic Audit Trail (E-364)
7. Part 11 Case Studies (Word) (E-411)
8. Part 11 Case Studies (PowerPoint) (E-411)
9. Case Studies - Electronic Audit Trail (word) (E-415)
10. Case Studies - Electronic Audit Trail (PowerPoint) (E-415)
11. Case Studies: How to Respond to Part11 Related 483's and Warning Letters (E-425)
12. Case Studies: How to Avoid Part11 Related 483's and Warning Letters (E-426)

13. Forms

Forms help implement 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)
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

14. 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. 2. Implementing Part 11 – Part 4: Data Migration and Long Term Archiving for Ready Retrieval
3. Impact of Part 11 on Chromatographic Data System

15. FDA Regulations and Guidelines

The package includes Part 11 as published in 1997 with the preamble as well as all six Part 11 Guidance Documents published so far by the FDA. It also includes most important guidelines for using computers published by the FDA, the EU and Japan.

16. 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 20 of such documents published by the FDA from 2007-2010. This section will be regularly updated. Updates are available through the on-line update service.

17. 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 Systems
2. Implementing Part 11 – Part 4: Data Migration and Long Term Archiving for Ready Retrieval
3. Impact of Part 11 on Chromatographic Data Systems

15. Case Studies

Case studies help 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.

17. 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.

18. 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

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