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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

  • CD
  • Web Download

 

Intro

 

CD includes

  1. 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
  2. 10 Standard  Operating Procedures
  3. 11 Validation Examples for easy implementation
  4. Five checklists/worksheets, just not to forget anythiong
  5. 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

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:

  1. Primer: FDA/EU Compliance in Analytical Laboratories - 55 pages (m-217)

3. 10 Standard Operating Procedures - Save days and weeks!

  1. Training for GxP, 21 CFR part 11 and computer validation (s-125)
  2. Development of User Requirement Specifications for Computer systems (s-253)
  3. Change Control of Software and Computer Systems (s-262)
  4. Validation of Macros Programs and other Application software (s-264)
  5. Validation of Electronic Laboratory Notebooks (S-267)
  6. Change Control For Networks and Systems (s-283)
    - Planned Changes -
  7. Change Control For Networks and Systems (s-284)
    - Unplanned Changes -
  8. Retention and Archiving of Electronic Records (S-315)
  9. Validation of Laboratory Computer Systems (S-656)
  10. 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!

  1. Project Schedule: Development and Validation of Macros&Spreadsheets (e-225)
  2. Project Schedule: Qualification of Networks (e-226)
  3. Requirement Specifications
    Real example for URS of Spreadsheet Application. You can also use this as a template for other programs. (e-269)
  4. Network/Computer System Identification (e-326)
  5. Inventory of Systems with Spreadsheets (e-328)
  6. Functional Testing of Software Applications (e-358)
    Includes test plan, test traceability matrix, test summary sheet and 11 test cases
  7. Test example – Authorized System Access (e-362)
  8. Validation Plan for Chromatographic Data Systems (E-781-01)
  9. Requirement Specifications For Chromatographic Data Systems (E-781-02)
  10. Supplier Assessment - Chromatography Data System (E-781-04) 
  11. Test plan - Chromatography Data System (E-781-06)  

6. 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

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

The author

The author, Dr. Ludwig Huber, is an international expert on laboratory compliance and quality standards. He has been responsible for the compliance and quality standards program at Hewlett Packard and Agilent Technologies for more than 20 years. He serves as a consultant for the industry and agencies on local and international compliance and quality 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 was/is on the advisory board for the European Compliance Academy and IVT's GxP Journals. 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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