Computer System Validation Package
Do it right the first time
With 35 SOPs, 21
examples/templates/forms, two audio seminars and free on-line
updates
Version 3 just introduced
Testimonials
So far we have received very positive
feedback from users of the package. To learn how the package
helped to validate software and computer systems, click here.
Now with two Options for Ordering

Intro

Training tools, strategies for compliance and
tools for implementation
Software and computer system validation is
required by regulations and it is important to ensure system
uptime during ongoing use. Despite of more than 30 years
experience and availability of FDA and industry guidance,
computer validation still confuses people.
This package helps you to
- Get a good understanding on FDA and
industry requirements
- Develop a strategy and master plans
- Implement the strategies with 50+
reference materials such as SOPs, checklists, forms, templates
Version 3.0 just
released
New or updated
features/documents in version 3 include
- Two new one hour audio presentations with
Q&As:
- Computer System Validation: Introduction, Requirements and
Strategies for Implementation
(Audio 156)
- Cost Effective Software and Computer System Validation: Take
Advantage of New Recommendations from FDA, EU Annex 11 and GAMP®
5 (Audio 202)
- SOP: Data Back-up and Restore (S-317)
- SOP: Developing a Gap Analysis for
Software and Computer System Validation (S-249)
- SOP: Access Control to Computer Systems
and Data (S-320)
- SOP: Archiving and Retrieval of GMP Data
and Other Documents (S-162)
- SOP: Disaster Recovery for Computer
Systems (S-319)
- 9 Examples for the Validation of
Electronic Document Management Systems
(Validation plan, Requirement Specifications, Vendor assessment,
IQ, OQ, PQ, Test plan, Test protocol, Validation report) (E-741)
- Updated: Computer System Validation
Master Plan
- Updated: Validation Plan - Chromatography
Data Systems
- Updated: Step-by-Step Implementation
- Three new forms
Testimonials, References and Sample Pages
So far we have received very positive
feedback from users of the package. To learn how the package
helped to validate computer systems, click here.
To see the table of contents and example pages of the Computer
System Validation Master Plan, sample pages from an SOP and
several pages of a checklist,
download
a zip file (sample pages are in PDF format, the products
comes with word and/or PDF formats)
Package Overview
- Two new one hour audio seminars with Q&As
and scripts:
- Computer System Validation: Introduction, Requirements and
Strategies for Implementation
(Audio 156)
- Cost Effective Software and Computer System Validation:Take
Advantage of New Recommendations from FDA, EU Annex 11 and GAMP®
5 (Audio 202)
(Train yourself and others on regulations and industry
practices)
- Primer: Validation of Computer Systems
- Computer System Validation Master Plan
and Project Plan
- Software and Computer Validation: Step by
Step Implementation
- Four Gap Analyses/Checklists: Using
computers in FDA regulated environments, user requirements for
computer systems, assessment of software vendors, New EU annex
11 - Using Computers
- 31 SOPs for change control, for risk
assessment of computer systems, for development and maintenance
of test scripts, validation of COTS computer systems, part 11
controls, for computer system training, for auditing computer
systems, for data back-up and restore, for access rights for
computer systems, for retention and archiving of electronic
records, for validation of electronic document management
systems and for disaster recovery of computer systems, for
developing a gap analysis
- MD5 software to verify file transfer
accuracy. This comes with validation documents.
- Template for computer system and network
characterization (baselining)
- 20 Practical Examples for Validating a
Document Management System and Chromatographic Data System
- Reference Paper: Risk based validation of
commercial off-the-shelf computer systems.
- 30+ most frequently asked question and
answers related to computer system validation.
- User Requirement Specifications: template
and examples
- Functional testing: template and examples
- 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 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 Updates
On-line updates - keeps you on top of ever
changing regulatory requirements
Laboratory compliance is quite dynamic. What
was enough yesterday is not enough any more today and what was
necessary last year may not be any more next year.
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
Laboratory Compliance package.
Updates include:
- New regulations related to laboratory
compliance and validation
- New guidelines from agencies and industry
task forces
- Interpretations what the new
regulations/guidance mean for laboratories and how to respond
- New SOPs, checklists and examples,
related to laboratory compliance, 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 computer systems to ensure security,
confidentiality, integrity and long term availability of data..
Examples are 21 CFR Part 11, Good Laboratory Practices, Good
Manufacturing Practices and Good Clinical Practices regulations and
Guidelines. This Computer System Validation Package will help to
comply with regulations and still meet business requirements.
Topics related to compliance:
- Checklist: using computer systems in FDA
regulated environments
- Part 11 checklist, also useful for other
regulations
- Checklist: New EU Annex 11 - Using
Computers
- Procedure: Risk Assessment for Systems
Used in GxP Environments, also useful for other regulations
- Procedure: Risk Based Validation
- Software and complete validation package
to verify file integrity
- Test procedure and protocol to test
limited access to systems and data
- More than 50 regulations and guidelines
related to computer validation
All in One
All in one - makes your work efficient and
keeps your budget under control
Computer Validation 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
- How to develop a computer validation
master plan?
- What is the level of detail of user
requirement and functional specifications?
- How to qualify the supplier: when is a
vendor audit a must?
- What and how much to test at
installation?
- I have multiple installations with the
same configurations, should I test all of them or is one enough?
- How to document functional testing - when
do I need to make screen captures?
- How to initiate and document changes to
my computer system?
- How to validate spreadsheets such as
Excel?
- How to qualify PC clients?
- What should we do when we retire a
computer system?
- How to validate existing (legacy)
systems?
- How to validate our document management
system?
- How to validate our laboratory computer
system?
Why to go through the hassle and read several
books with lots of redundant information. With this validation
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: Validation of Software and
Computer Systems
This gives an overview on regulatory
requirements and validation principles. It discusses and gives
recommendations for developing a validation plan, setting
specifications, vendor qualification, installation, testing for
initial and on-going operation of the system All from business AND
regulatory perspective. Updates will be available through the
on-line update service.
2. Two Audio seminars:
(NEW)
- Computer System Validation: Introduction,
Requirements and Strategies for Implementation
(Audio 156)
- Cost Effective Software and Computer System Validation: Take
Advantage of New Recommendations from FDA, EU Annex 11 and GAMP® 5
(Audio 202)
In the first seminar Dr. Ludwig Huber gives an
introduction on regulatory requirements and strategies for
software and computer validation
The second seminars helps IT and validation
processionals to make validation most cost and time effective.
3. Step-by-Step Implementation
(UPDATE)
This documents guides owners of validation
projects through the complete process from planning to
implementation and on-going validation.
4. Computer System Validation Master Plan
(UPDATE)
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. A validation master plan is also officially required for
EU GMPs through Annex 15.
5. Computer System Validation Project Plan:
Template and examples (UPDATE)
Validation of computer systems requires
thorough planning and execution. While the master plan provides a
framework for all validation projects, a project plan is required
for each individual project. This example list project steps and
also has an appendix with a project schedule with columns for
project items, deliverables, owners and timing.
6. 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
Computer System Package includes several example SOPs
- Writing and Distribution of Electronic
SOPs (S-107)
(NEW)
- Training for GxP, 21 CFR Part 11 and
Computer Validation (S-125)
- Risk Assessment for Systems Used in GxP
Environments (S-134)
- Recording of GMP Raw Data
(S-161)
(NEW)
- Archiving and Retrieval of
GMP Data and other documents (S-162)
- Archiving and Retrieval of
GCP Source Data (S-164) (NEW)
- Development and Maintenance of Test
Scripts for Equipment Hardware, Software and Systems (S-237)
- Developing a Gap Analysis for
Software and Computer System Validation (S-249)
- Risk Based Validation of Computer Systems
(S-252)
- Development of User Requirement
Specifications for Computers (S-253)
- Configuration Management and Version
Control of Software (S-259)
- Revalidation of Software and Computer
Systems (S-260)
(NEW)
- Retirement of Computer Systems (S-261)
- Change Control of Software and Computer
Systems (S-262)
- Validation of Macro Programs and Other
Application Software (S-263)
- Using Macros and Spreadsheets in a
Regulated Environment (S-265)
- Validation of Electronic Laboratory
Notebooks (S-267)
- Validation of Document Management Systems
(S-270)
- Validation of Commercial Off-the-shelf
(COTS) Computer Systems (S-271)
- Auditing Computer Systems (S-272)
- Auditing Software Suppliers: Preparation,
Conduct, Follow-up (S-273)
- Quality Assessment of Software and
Computer System Suppliers (S-274)
- Responsibilities for Computer System
Validation (S-277)
(NEW)
- Qualification of PC Clients (S-289)
- Retention and Archiving of Electronic
Records (S-315)
- Scanning of Paper Records for GxP
Compliant Archiving (S-316)
- Data Back-up and Restore
(S-317)
- Handling Contingency
Situations for Computer Systems (S-318) NEW
- Disaster Recovery for
Computer Systems (S-319)
- Access Control to Computer
Systems and Data (S-320)
- Validation of Laboratory Computer Systems
(S-656)
7. Checklist / Worksheets
Gap analyses and checklists are key to
identify missing procedures and technical controls for computer
system validation. The Package includes three gap analyses
- Checklist: Cost Effective Computer System
Validation (E-150)
NEW
- Checklist: EU GMP Annex 11 - Using
Computers
(E-151)
NEW
- User Requirement Specifications for
Software and Computer Systems (E-153)
- Commercial Off-the-Shelf Computer Systems
(E-160)
- Assessment of Software Vendors (E-321)
8. Templates and Examples
Templates and examples help implement the
computer system validation processes effectively and consistently
throughout your organization. The Package includes
templates/examples for
- Requirement Specifications For Excel
Applications (E-269)
- MD5 Checksum File Integrity Check
Software with Validation Documentation: DQ, IQ, OQ, PQ (E-306)
- User Requirement Specifications - 20
Good/Bad Examples (E-308)
- Computer System and Network
Identification (E-326)
- Template/Examples: Test Protocol For
Excel™ Spreadsheet Application (E-358)
(with traceability matrix): Includes
12 test scripts examples for functional testing, includes
boundary testing, out of range testing, test traceability
matrices: tests vs. specifications, specifications vs. test
cases, test summary sheet
- Testing of Authorized System Access
(E-362)
- Case Studies: Configuration Management
and Change Control for Software and Computer Systems. (E-413)
- Validation Plan - Electronic
Document Management System (E-741-01)
- Requirement Specifications -
Electronic Document Management System (E-741-02)
- Vendor assessment -
Electronic Document Management System (E-741-04)
- DQ - Electronic Document
Management System (E-741-05)
- Test plan - Electronic
Document Management System (E-741-06)
- IQ - Electronic Document
Management System (E-741-07)
- OQ - Electronic Document
Management System (E-741-08)
- PQ - Electronic Document
Management System (E-741-09)
- Validation Report -
Electronic Document Management System (E-741-11)
- Validation Plan for Chromatographic Data
Systems (E-781-01)
- Requirement Specifications For
Chromatographic Data Systems (E-781-02)
- Supplier Assessment -
Chromatography Data System (E-781-04) NEW
- Test plan - Chromatography
Data System (E-781-06) NEW
9. Forms
Forms help implement the computer system
validation processes effectively and consistently throughout your
organization. The Package includes forms for
- Computer System Validation
Project Team (K-1311)
- Computer System Validation
Steering Committee (K-1312)
- Computer Validation Training
(K-1313)
- Requirement Specifications
Table (K-1319)
- Change Request Form (K-1320)
- Change Release Form (K-1321)
- Retirement Request Form
(K-1322)
- Validation Deliverables
(K-1323)
- Computer System
Identification for Validation (K-1324) NEW
- Computer Incident Report
(K-1361)
NEW
- Cost Control for Computer
Systems (K-1371)
NEW
- Traceability Matrix Excel
Specifications-Test Cases (K-1342)
10. 30+ Most Frequently Asked Questions and
Answers
This section includes more than 30 questions
and answers on software and computer system validation we received
during our audio seminars, conference workshops and through e-mail.
11. FDA Regulations and Guidelines
The package includes includes most important
guidelines for using computers published by the FDA, the EU and
Japan.
12. On-line Updates
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.

Testimonials/References
The Feedbacks on the Package have been
received by e-mails. Labcompliance has permission to use the
testimonials as references. Original e-mails are stored in the
Labcompliance archive.
-
Mr. Lawrence DeHeer, President, Blaze Systems
Corporation, USA (Ref 1032)
Comprehensive coverage with examples. Well structured and broken
down into manageable pieces. Aligns and supports the most
rigorous examples we have encountered and also demonstrates the
inadequacies of less rigorous examples we have seen, helping us
to guide our customers. This package is a must have starting
point for anyone tasked with insuring a credible software
validation effort. Worth many times the price. The package did
exceed my expectations.
- Michael Brooks, AIT Laboratories,
Quality Assurance, USA
The package did exceed my expectations. It has more than enough
of what we need to meet regulatory regulations. Very well put
together (Ref 1002)
-
Mr. Suwardi Bambang Irawan Syah, Idaman Pharma Mfg Sdn Bhd,,
Malaysia
Feedback: The package clearly stated how to do the CSV..
The package did exceed my expectations. (Ref T-1027)
-
Mr. Jim Dougherty, Sr. Mgr. Software Iron Mountain, IT Software
Engineering, Engineering, USA
Comprehensive coverage of topics, Excellent examples. (Ref: T-1028)

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