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Internet Quality Package

Effectively Use Your Intranet and Internet and Comply with Recent Regulations

With audio seminar and free on-line updates

Intro

Take Advantage of Modern Technologies and Comply with FDA Regulations

The Internet is increasingly used for all types of businesses including healthcare industry. The Internet by it’s nature is an insecure and unreliable environment and therefore without special precautions is not compliant FDA regulations

This package helps you to

  • Get a good understanding on specific requirements of regulations
  • Develop a strategy to use Intranet and Internet in regulated environments
  • Implement the strategies with 20+ reference materials such as SOPs, checklists, templates

Package Overview

  1. A one hour audio presentation with Q&As: Using the Internet and Intranet in Regulated Environments
    (Train yourself and others on regulations and industry practices)
  2. Primer: Using the Internet and Intranet in Regulated Environments
  3. Internet Quality and Compliance Master Plan
  4. Internet Quality and Compliance: Step by Step Implementation
  5. Validation master plan for equipment, computer systems and networks
  6. Three Gap Analyses/Checklists: Using Internet in Regulated Environments, Network Qualification, Using computers in FDA regulated environments
  7. 10 SOPs for planned and unplanned changes, for risk assessment of networks, for security access testing, validation of web-based applications, handling security patches, validation of COTS computer systems, part 11 controls, for people qualification, for auditing computer systems and for development of test scripts
  8. Tutorial: Getting and Using Digital Signatures for E-mail
  9. MD5 software to verify file transfer accuracy. This comes with validation documents.
  10. Template for network/system characterization (baselining)
  11. Three NIST guides related to Internet security.
  12. Two years free on-line updates

Target Audience

  • IT/IS managers and personnel
  • Operations managers and personnel
  • Lab managers and personnel
  • QA managers and personnel
  • Analytical scientists
  • Validation specialists
  • Consultants
  • Teachers

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 Updates

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

Web infrastructure and applications are quite dynamic. Besides that 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 procedures and the Internet for the updates. That's why the author offers two year free on-line updates with the purchase of the internet quality package.

Updates include:

  • New regulations related to intranet compliance and computer validation
  • New guidelines from agencies and industry task forces
  • Interpretations what the new regulations/guidance mean for networks and how to respond
  • New SOPs, checklists and examples, related to network qualification, if necessary

Registration is automatically with each package purchase from Labcompliance

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

 

Support for Compliance

With support for new laws and regulations

Federal laws and regulations mandate to put controls and measures on a company network and intranet to ensure security, confidentiality, integrity and long term availability of data.. Examples are 21 CFR Part 11, Sarbanes-Oxley Act, and HIPAA. With this new legislation Internet and Intranet qualification and compliance become a much more recognizable issue at higher levels of management. However currently there is no official guideline and the situation is similar to what happened with computer validation in early 90's, with network qualification in 2000 and 2001 and with general part 11 issues from 2000 to 2003. Until there will be an industry wide accepted approach companies either waste valuable resources because doing too much or take a risk to fail inspections because not doing enough or doing it wrong. This Internet Quality Package will help to comply with regulations and still meet business requirements.

Topics related to compliance:

  • Part 11 checklist, also useful for other regulations
  • Procedure: Risk Assessment for Systems Used in GxP Environments, also useful for other regulations
  • Procedures: 21 CFR Part 11 - Scope and Controls, also useful for other regulations
  • Procedures to handle security, e.g., security patches, training
  • Software and complete validation package to verify file integrity
  • Procedure to verify integrity of e-mail attachments
  • Test procedure and protocol to test limited access to systems and data

All in One

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

Making Internet and Intranet infrastructure and applications 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 compliance but none gives a full picture and details that are required for quick implementation.

This package is a single source covering all aspects. It is written by a single author who has more than 10 years practical international experience and understands FDA compliance 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:

  • Can I use the internet for FDA regulated applications?
  • What are FDA's expectations for Part 11 requirements?
  • How to validate the internet?
  • How to validate web applications?
  • How to ensure and verify accuracy of file transfer through the e-mails?
  • Do I need 3rd party certificates for digital signatures?
  • How to ensure limited and authorized access to closed and open systems?
  • How can I safely access the company intranet while traveling?
  • How to best protect my computer from internet attacks?
  • How to handle security patches?

Why to go through the hassle and read several books with lots of redundant information. With this quality package 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: Using Intranet and Internet in FDA Regulated Environment

This gives an overview on regulatory requirements and Internet technology. It discusses and gives recommendations for digital signatures, validation of internet transactions and internet security. All from business AND regulatory perspective. Updates will be available through the on-line update service.

2. Audio seminar: Using Internet and Intranet in Regulated Environments

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 make internet applications compliant in a most cost-effective way.

3. Internet Quality&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. Internet Quality and Compliance - 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. Gap Analysis/Check List

Gap analyses and checklists are key to identify missing procedures and technical controls to for Internet/intranet compliance. The Package includes two gap analyses

  1. Internet Quality and Compliance
  2. 21 CFR Part 11 Compliance
  3. Using Computers in FDA regulated environments

7. 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 Internet Quality Package includes several example SOPs

  1. Using Internet in FDA Regulated Environments
  2. Validation of Web-based Applications
  3. Handling Security Patches
  4. Testing File Integrity of E-mail Attachments
  5. Auditing Computer Systems
  6. Training for GxP, 21 CFR Part 11 and Computer Validation
  7. Validation of Commercial Off-the-shelf Computer Systems
  8. Development and Maintenance of Test Scripts for Equipment Hardware, Software and Systems
  9. Validation of Macros and other Application Software
  10. Change Control for Network and Systems - Unplanned Changes
  11. Change Control for Network and Systems - Planned Changes
  12. Risk Assessment for Systems Used in GxP Environments.

8. Templates and Examples

Templates and examples help implement the Internet Quality processes effectively and consistently throughout your organization. The Package includes templates/examples for

  1. MD5 Checksum File Integrity Check Software with Validation Documentation
  2. User Requirement Specifications - Example
  3. Testing Protocol for Authorized System Access
  4. Network Infrastructure and System Identification

9. Tutorial

  1. Tutorial: Getting and Using Digital Signatures for E-mails

10. FDA Regulations and Guidelines

The package includes includes most important guidelines for using computers published by the FDA, the EU and Japan.

11. NIST Guides Related to Internet Security

  1. Guidelines on Electronic Mail Security.
  2. Procedures for Handling Security Patches
  3. Guidelines on Firewalls and Firewall Policy

12. 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 - Ludwig Huber

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