21 CFR Part 11 Compliance Package

Electronic Records & Electronic Signatures

With audio presentation and free on-line updates

Now with Video Seminar

How to Prepare Your Organization for the 'New' Part 11

- Learn What's Coming and How to Implement -

Make Sure Your Company Complies with the New Scope of Part 11 - 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 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 1.2

New Video Seminar: How to Prepare Your Organization for the 'New' Part 11: Learn What's Coming and How to Implement
Presentation from FDA's Georg Smith: Past, Present and Where we are Going (available through the audio seminar)
New Part11 checklist: Reflecting FDA's New Scope and anticipated changes in the 'New' Part 11
12 Case Studies on how to implement FDA's new scope and anticipated changes with the NEW Part11
Updated SOP: Part11 Scope and Controls
New FDA Industry Guidance: Using Electronic Means to Distribute Certain Product Information
FDA Field Management Directive
Electronic Records: Electronic Signature Certificate
New most recent FDA Warning Letters and 483 Inspectional Observations Related to Part 11

Package Overview

Video seminar: How to Prepare Your Organization for the 'New' Part 11
Audio seminar: 21 CFR Part 11 - Electronic Records and Signatures
Introduction and Strategies for Cost-effective Compliance
Primer: 21 CFR Part 11 - Electronic Records and Signatures: Background, requirements, new FDA interpretations and scope, implementation, applications, examples.
Part 11 Compliance Master Plan
Validation master plan for equipment, computer systems and networks
Risk management master plan
Part 11 project schedule with tasks and deliverables
Three Gap analysis/Checklist: Part 11, Using computers in FDA regulated environments, Requirement Specifications
Validation Examples: URS for Part 11, URS for Chromatographic data systems
11 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.
Templates and examples for part 11 implementation and validation
12 Case studies with graphical and tabular workflow, recommendations and documentation
80 most frequently asked question and answers related to Part 11.
FDA and other national and international regulations and guidelines related to GxP and electronic records/signatures
FDA Warning letters and 483 inspection reports related to Part 11 from 1997 to 2006
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: Binder, CD
Size: More than 1000 pages, when printed
Price: US$ 499.- (includes shipping and free on-line update for two years).
VAT will be added for EU countries.
Availability: Worldwide, shipment within one working day
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 :

2.1: 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.

2.2. 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. Gap Analysis/Check List

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

21 CFR Part 11 Compliance
Using Computers in FDA regulated environments
Commercial Off-the-shelf Computer Systems

9. 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.

10. 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

Training for GxP, 21 CFR Part 11 and Computer Validation
Risk Assessment for Systems Used in GxP Environments.
This to identify risk levels for computer Systems
Part 11 Scope and Controls
Used to define, justify and document requirements for part 11
Testing File Integrity of E-mail Attachments
Validation of Commercial Off-the-shelf Computer Systems
Risk Based Validation of Computer Systems
Auditing Computer Systems
Retention and Archiving of Electronic Records
Change Control of Computer Systems
Scanning of Paper Documents for FDA Compliant Archiving
Assessment of Suppliers of Software and Computer Systems

11. Validation Template, Forms and Example

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

Computer System Identification
User Requirement Specifications for Chromatographic Data Systems
User Requirements for Part11
Part 11 Case Studies
Testing of Authorized System Access
Project Schedule 21 CFR Part 11
Case Studies: 21 CFR Part 11 – Scope and Controls

12. 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.

13. 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 1997 to 2005. This section will be regularly updated. Updates are available through the on-line update service.

14. Reference Papers

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

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

15. Case Studies

Case studies help to implement Part 11 for specific systems. The package includes 12 case studies with visual representations, business practices and recommendations which Part 11 requirements should be implemented for each system.

16. 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.

17. 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 validation and compliance in regulated industries and laboratories. He has been responsible for the compliance program at Hewlett Packard and Agilent Technologies for more than fifteen years. He serves as a consultant for the industry and regulatory agencies on local and international compliance 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 on the advisory board for the European Compliance Academy and is a member of IVT task force on network qualification. 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

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