Validation of Computerized Analytical and Networked Systems

With 21 CFR Part 11support and free on-line updates

Intro

67% of warning letters to drug and biologic firms cite laboratory controls. The FDA shifted the lab inspection focus from analytical methods and equipment hardware to software and most recently to electronic records and networked systems. Computer validation and critical data generated by the computer are a major concern. Validation of computer systems is also a key requirement of FDA's 21 CFR Part 11 on electronic records and signatures. And with frequent use of networks, validation becomes more complex. This book written by Dr. Ludwig Huber answers important questions: what to validate, when to validate, and how to validate all aspects of computers and electronic records for laboratories.

Features include:

All information on one place: clear, logical guidance through the entire validation process - from specifications, design and development to installation and operational qualification and ongoing performance and change control - speeds up the process and helps to do it right the first time
Criteria and procedure for vendor audits with vendor assessment checklist
Special attention to FDA's 21 CFR Part 11 (E-Records/signatures)
Guidelines and examples on how to validate networked systems, Macros and spreadsheets
Strategy with gap analysis, risk assessment and implementation plan for existing systems
Coverage of all major national and international regulations and quality standards to help readers to be in compliance
Templates offering documentation examples
Checklists to help assure that all aspects of the validation workload are covered quickly and effectively in logical sequence
Useful appendices, including SOPs for validation of new and existing hardware and software, plus more than 100 backup references

Target Audience

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

Format/Price/Ordering

Format: Bound Book
Size: 230 Pages
Price: US$ 299.- (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

Validation of software and computer systems is almost as dynamic as computer technology. Regulatory agencies and industry task forces frequently release or update regulations or guidance documents. J

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 book for the fundamentals and the Internet for the updates. That's why the author offers three year on-line updates with the purchase of a book.

Updates include:

New regulations related to computer validation
New guidelines from agencies and industry task forces
Interpretations what the new regulations/guidance mean for analytical laboratories and how to respond
Updates to book text, tables, checklists, SOPs and glossary, if necessary

Registration is automatically with each package purchase from Labcompliance

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

Part 11 Support

Part 11 is the most important regulation that hit the pharmaceutical industry in the last 20 years. It has an impact on how laboratories operate and validate computerized analytical and networked systems. This book describes the technical and administrative requirements of the rule and provides step-by-step recommendations for implementation.

A special chapter entitled "Operational Compliance of Legacy Systems" guides users of existing systems from developing a part 11 compliance strategy through a gap analysis to a risk assessment based 'active' implementation plan. Part 11 is still evolving and needs more interpretation and guidance from the FDA and Industry. The 'on-line' update support feature of the book will reflect any future FDA and Industry task forces guidance documents.

Topics related to Part 11:

FDA's inspection and enforcement practices, situation in Europe
Terminology: for example, open/closed systems, e-signatures vs. e-records
Scope of part 11
E-records in analytical systems: raw data vs. meta data
Validation requirements
Limited access to systems and data
Binding signatures to records with special consideration of multi-user systems
Long term archiving ready retrieval of data and meta data
When audit trail start and contents
Implementation plan for new and existing systems
Part 11 compliance master plan
System inventory, part 11 assessment and gap analysis
Development of administrative controls
Risk assessment for priority systems

All in One

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

Validation of software and computer systems 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 IQ/Q/PQ but none gives a full picture and details that are required for quick implementation in laboratories.

This book 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 validation from ground.

The author has been ranked as number one presenter at various international conferences and the book answers all questions typically raised at these conferences:

How to write a validation master plan?
How to write user requirement and functional specifications?
How to validate software during development?
How to assess vendors without an audit? How to effectively perform vendor audits, if required?
How to check that software is 'properly' installed?
What and how to test before and during operation of Commercial Off the Shelf Systems?
How to develop and implement change control procedures?
What to validate after a software, firmware or hardware upgrade?
How to validate spreadsheets and Macro programs?
How to validate networked systems, for example lab-data systems or LIMS?
How to validate existing systems?
How to implement 21 CDR Part 11 in Laboratories?
How to audit computerized systems, from audit design to evaluation and reporting?

Why to go through the hassle and read several books with lots of redundant information. With this validation book, 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.

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Contents, chapter by chapter

1. Introduction

2. Regulations and Quality Standards with Impact on Computer Validation

(Current) Good Manufacturing Practice (cGMP) Regulations
Good Laboratory Practice (GLP) Regulations
Good Clinical Practice (GCP) Regulations
Good Automated Laboratory Practice (EPA's GALP and Cromerr)
Electronic Records and Signatures (21 CFR Part 11)
Good Automated Laboratory Practice (EPA's GALP and Cromerr)
ISO/IEC 17025
Inspectional Observations and Inspection Trends, FDA Warning Letters,

3. Terminology and responsibilities

Definition and elements of validation
Validation versus verification and qualification
Qualification and Testing
Computer Systems and Computerized Systems
Software categories, GAMP categories
Validation processes in a laboratory and Validation timeline
Validation strategy and policies
Validation steering committee and validation project teams
Company validation master plan
Individual project validation plans
Summary recommendation for validation planning and implementation

4. Design Qualification

Recommended steps in design qualification
User requirement specifications
Functional specifications
Selected Examples

5. Vendor Assessment

Vendor Assessment Levels
Criteria and Recommendations for Vendor Audits
Vendor audit checklist

6. Validation During Development

Development and validation overview
Checkpoint meetings
Setting User Requirement and Functional Specifications
Design Phase
Implementation Phase
Testing
- Types of testing
- a -Testing
- b -Testing
Release for Production and Installation
Operation and Maintenance
Change Control
Documentation

7. Installation Qualification

Preparing for Installation
Installation
- Logbook
- Operator Training
- Documentation

8. Operational Qualification

Selecting tests based on risk assessment
Performing and documenting tests
Example for integrated system testing
Defining data files and test routines for reuse
Tests of multiple computer systems
Requalification
Documentation

9. Maintenance and Ongoing Performance Qualification

Preventive Maintenance
Virus checks
Data Back-up and Archiving
Disaster recovery
On-going Performance Testing
Change control
Documentation

10. Validation of Macros and Spreadsheet Programs

What should be validated?
Planning and setting specifications
Designing the program
Developing the code
Testing
Using Spreadsheets and Macros
Documentation

11. Validation of Networked Systems

FDA findings and expectations
Systems and Tasks to be Validated
Examples of Networked Systems
The Qualification/Validation Approach Using the 4Q Model
Validation Master Plan and Validation Team
Setting Specifications (URS, FS)
Installation
Testing
Data Back-up, Recovery and Contingency Planning
Change Control and Maintaining Security
Documentation
Implementation summary

12. Compliance with Electronic Records and Signatures (21 CFR Part 11)

Development and current status of the rule
Scope of part 11 for chromatographic systems
Electronic records in chromatography
Requirements of 21 CFR Part 11
- System validation
- Secure retention of electronic records to instantly reconstruct the analysis
- Limited access to authorized users
- Binding signatures with records
- User independent computer generated time stamped audit trails
- Use of secure electronic signatures for closed and open systems
- Use of digital signatures for open systems
Recommendations for implementation

13. Operational Compliance of Legacy Systems

Regulatory requirements, inspection findings, FDA's enforcement practices
Compliance policy and master plan
Administrative controls
System Inventory, Gap and Risk Analysis
Cost analysis
Implementation plan
Retrospective Evaluation
- Specific characteristics of older systems
- Procedure for retrospective evaluation

14. Audits

Audit findings
Planning, Implementing and Reporting Internal Audits
Audit evaluation and reports

Appendix A. Glossary

Appendix B. Standard Operating Procedures

Appendix C. Selected (Standard) Operating Procedures
- General recommendations:
- Types and/or content of SOPs
  - Example #1: Development and Validation of Simple Application Software
  - Example #2: Development and Validation of a Complex Application Software
  - Example #3: Retrospective Evaluation and Validation of Existing Computerized Analytical Systems
  - Example #4: Development of User Requirement Specifications

Appendix C. Literature

Appendix C. References

Bundle: Book plus CD - 13% savings

Includes the book: Validation of Computerized and Networked Systems
Handy Validation Reference for your entire laboratory
CD: Validation of Computerized and Networked Systems
- Interactive video for quick introduction and overview
- SOPs, examples, checklists for easy implementation
- Regulations, guidelines as reference material
On-line update for 2 years
- Keeps you up-to-date with ever changing FDA expectations

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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