Validation of Computerized Analytical and Networked Systems
- Video Training and Best
Practice Guides -
Helps to quickly understand and implement computer&software
validation
Version 3 just introduced
Now with two Options for Ordering
Intro
CD includes
- An interactive video/CD with 38 clips: convenient and
efficient multimedia training from your desk or in a team
Title: Validation of Software and Computer Systems in Analytical
Laboratories (presenter: Dr. Ludwig Huber
- 10 Standard Operating Procedures
- 11 Validation Examples for easy implementation
- Five checklists/worksheets, just not to forget anythiong
- 40+ FDA Regulations and guidelines related to GxP, computer
validation and 21 CFR Part 11, e.g., more than 20 predicate
rules: help to understand FDA regulations and FDA's current
thinking
- 17 FDA Warning Letters/Establishment Inspection Reports
(EIR) and/or 483 inspectional observations related to computer
validation and equipment qualification - with keywords for easy
searching. Learn from and avoid mistakes others made
- Documents from agencies in Europe and Asia related to
computer validation
CD with Interactive Video Training, SOPs,
Worksheets and Reference Material
The validation reference text book Validation of Computerized
Analytical and Networked System is ideal to get detailed information
on why, what and how to validate computer systems in laboratories.
Books are very convenient for longer reading of detailed information.
However, to get a quick and convenient overview intuitive multimedia
training tools are preferred. Such electronic tools have also the
advantage that they have enough space to hold back-up and reference
material. That's the reason why we have developed this CD ROM as as
complementary tool to the text book. It is an ideal training tool
and has all the working tools and reference material that is
required to quickly implement and back-up your validation work.
Detailed Contents
1. Interactive Video presentation
- 38 Video clips on CD
- On MS Powerpoint, comes with Powerpoint Viewer
- Contents
- Regulatory requirements, inspection findings
- Validation approach, master plan, validation team
- Vendor assessment without and with vendor audit
- User requirement vs. functional specifications
- Testing for 'proper' software installation
- Testing for initial and on-going operation
- Examples for worst case testing
- Validation of existing systems
- Validation of spreadsheets and macros
- Change control
- Validation report
2. Primer:
-
Primer: FDA/EU Compliance in Analytical Laboratories - 55 pages
(m-217)
3. 10 Standard Operating Procedures - Save days and weeks!
- Training for GxP, 21 CFR part 11 and computer validation
(s-125)
- Development of User Rrequirement Specifications for Computer
systems (s-253)
- Change Control of Software and Computer Systems (s-262)
- Validation of Macros Programs and other Application software
(s-264)
- Validation of Electronic Laboratory
Notebooks (S-267)
- Change Control For Networks and Systems (s-283)
- Planned Changes -
- Change Control For Networks and Systems (s-284)
- Unplanned Changes -
- Retention and Archiving of Electronic
Records (S-315)
- Validation of Laboratory Computer Systems
(S-656)
- Risk Assessment for Laboratory Computer Systems (s-662)
4. Five Gap Analyses and Checklists - For complete
implementation - just not to forget anything!
- Part 11 Checklists (e-168)
-
Part 11 Validation Assessment List (e-169)
-
Qualification of Networks and Validation of Networked Systems (e-157)
-
Vendor Assessment (e-321)
-
Laboratory audits (e-184)
5. 11 Templates and Examples - For effective and
consistent implementation - take the easy way!
- Project Schedule: Development and Validation of
Macros&Spreadsheets (e-225)
- Project Schedule: Qualification of Networks (e-226)
- Requirement Specifications
Real example for URS of Spreadsheet Application. You can also
use this as a template for other programs. (e-269)
- Network/Computer System Identification (e-326)
- Inventory of Systems with Spreadsheets (e-328)
- Functional Testing of Software Applications (e-358)
Includes test plan, test traceability matrix, test summary sheet
and 11 test cases
- Test example – Authorized System Access (e-362)
-
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)
-
Test plan - Chromatography Data System (E-781-06)
6. Text of twenty+ FDA 'Predicate Rules'
- Good Laboratory Practice (GLP)
- Current Good Manufacturing Practice
- Good Clinical Practices (GCP)
- Animal drugs
- Medical device
- Quality systems
- Food
- Electronic records and signatures (part 11) with preamble
7. FDA guidelines related to computer validation
- 7. Guidance documents related to part 11, six of them have
been withdrawn but are still worthwhile to understand
- General principles of software validation
- Off-the-shelf software use in medical devices
- Computerized systems used in clinical trials
- Glossary related to computerized system and software
- Inspection guides related to computer systems and software
- Investigational training manual related to inspection of
computer systems
- Five guidelines related to e-submissions
8. 17 FDA Warning Letters, Establishment Inspection Reports
(EIR) and/or 483 inspectional observations
- related to computer validation, network qualification and
part 11 - with keywords for easy searching
- reflect FDA's 'thinking' about details
- useful in preparation for audits
- help to avoid inspectional observations and warning letters
9. Documents from Agencies in Europe and Asia Related to
Computer Validation
- Annex 11 of EU GMP Directive, includes, requirements for
computer systems (2008)
- APV 27 page interpretation guide for Annex 11. Help to
understand EU perspective of requirements to computer systems
and e-records
- Annex 15 of EU GMP directive on "Validation and
Qualification"
- PIC/S Good Parctice Guide: Using Computers in GxP
Environments
- Japanese Guideline on control of computerized Systems in
Drug Manufacturing
- ICH Guide on GMP for Active Pharmaceutical Ingredients
- ICH Guidance E6 for Good Clinical Practice
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: CD
- Size: NA
- Price: US$ 259.-
- VAT will be added for EU countries.
- Availability: Worldwide, shipment within one working day
- Ordering:
- Electronically from this this web site (SSL secured)
- Regular mail or fax using the form in
PDF or
MS Word format
Bundle: Book plus CD - 13% savings (currently not available)
- Includes book: Validation of Computerized Analytical and
Networked Systems
Handy Validation Reference for your entire laboratory
- CD: Validation and Qualification in Analytical Laboratories
- 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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