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All documents as shown here are included in the package, and many more!

 

A total of 13 SOPs are included in the package.

 

 

 

 

 

 

 

The LIBs show how the FDA is using Excel in their own laboratories.

These documents are not available on FDA's website.

The package includes forms for effective and consistent implementation

Validation and Use of Excel in Regulated Environments. With FDA's Dennis Cantellopps and Dr. Ludwig Huber

 

 

The Package includes 5 FDA warning letters, 483's/ EIR's related to topics in the Package

The package includes over 100 FDA and International Regulations and guidelines

Here are just a few examples

 

Macro and Spreadsheet Quality Package

Using Excel Spreadsheets in Regulated Environments

Testimonials

So far we have received very positive feedback from users of the package and other materials related to spreadsheets. To learn how the package helped to validate and use macros and spreadsheets in regulated environments, click here.

Now with two Options for Ordering

  • CD/Binder
  • Web Download

Intro

  • Are you using Excel in a regulated environment, e.g., GLP/GCP/GMP/Part11/Annex11/HIPAA?
  • Do you want to reduce failure rates of Spreadsheet applications?
  • Do you want to increase efficiency for development and use of Macros and Spreadsheets?

If the answer to any one of the questions is 'yes', you should get the Macro&Spreadsheet Quality Package from Labcompliance.

 

Spreadsheets are frequently used in regulated environments, e.g.,laboratories and production. They need to be validated and comply with FDA 21 CFR Part 11 and other regulations. Generally they have not been designed for regulated environments. Planning, development and use typically is not well organized leading to high failure rates. There is hardly any information available on how to deal with this issue. Labcompliance has developed a package to address this gap.

 

June 2010: Version 3 released

New or updated features/documents include

  • Audio seminar: Validation and Use of Excel® Spreadsheets in GLP/GMP and Part 11 Environments. With FDA's Dennis Cantellops and Dr. Ludwig Huber
  • Primer: 45 pages, with updates reflecting FDA's current approach for Part 11.
  • Validation of Spreadsheets Applications: Ste-by-Step from Beginning to End, with examples for all validation documents.
  • SOP: Retention and Archiving of Electronic Records. .
  • SOP: Development and maintenance of equipment hardware, software and systems
  • SOP: Development and maintenance of test scripts for equipment hardware, software and systems
  • SOP: Access Rights to Computer System and Data
  • SOP: Retrospective Validation of Computerized Systems
  • SOP: 21 CFR Part 11 Scope and Controls
  • GAP analysis/checklist for macros&spreadsheets, updates with risk assessment items.
  • Updated 483 inspectional observations, detailed inspection report on follow up inspection that demonstrates how the deviations have been fixed
  • Forms for effective and consistent implementation

The package includes both of FDA's Laboratory Information Bulletins on
Design and Validation of Spreadsheets:

  • Part I: Multi-User Application Workbooks
  • Part II: Single User Application Workbooks

Package includes

  1. SOPs for development, validation and use of Macros and Spreadsheets for highest efficiency and consistency.
  2. SOPs for validation, change control and training.
  3. Procedures for risk assessment and limited access.
  4. MD5 example software to verify file 'proper software installation and integrity of the spreadsheet (incl. complete set of validation: DQ, IQ, OQ test procedure, PQ).
  5. Interactive audio seminar for fast and intuitive familiarization with the topic, with FDA's Dennis Cantellops answering most frequently asked questions.
  6. Validation examples from project planning to validation report
  7. Primer for extensive background and reference information.
  8. FDA 483 observations, warning letters and full follow up inspection report (EIR) describing corrective actions.
  9. Extensive gap analysis/checklist to prepare for successful inspections, with gaps for risk assessment.
  10. Excel Macro example with validation documentation such as project plan, inventory list, requirement specifications, test plan, traceability matrix and test scripts for fast implementation.
  11. Excel template example to demonstrate record integrity (user can enter and re-enter data, print and exit, nothing else, menu and CRTL items are removed).
  12. Special Excel operating manual with functions dedicated to assist for GxP and Part 11 compliance.
  13. Two year on-line updates to stay on top of ever changing regulations -
    Register now.
  14. Two FDA's Laboratory Information Bulletins on
    Design and Validation of Spreadsheets: Single-User and Multi-User workbooks, not available on FDA's public website.

Example of a template to demonstrate data integrity

  • Recommended for 'high risk' applications.
  • Using VBA script menu bars and CTRL commands have been removed to fully protect the worksheet
  • Operators only have access to: enter and re-enter data, print or exit
  • Information on date/time, source directory, file/worksheet/version in the print-out to demonstrate traceability and integrity
  • Plausibility checks for data inputs to reduce error rate
  • Ease of use with colored cells for data entries (yellow), expected results (green) and unexpected results (red)
  • With practical hints for operators on how to follow up to unexpected results.

ALL menu and CTRL bars removed for highest integrity

 

Package Contents

1. Interactive Seminar with FDA's Dennis Cantellops and Ludwig Huber

  • Regulatory requirements for spreadsheets; FDA Part 11, GxP, HIPAA, Sarbanes-Oxley.
  • Recommendations from the new GAMP®5 and Annex 11
  • How to design spreadsheets for compliance.
  • How to ensure and validate spreadsheet integrity.
  • When, what and how much to test?
  • Validation of standard/native Excel functions?
  • How to apply risk based validation to spreadsheet applications
  • Validation of 'ad hoc' spreadsheet applications.
  • How to document planning, specifications, installation, testing and changes
  • How FDA is validating using Excel for compliance
  • Examples from manufacturing, laboratories and offices
  Dennis Cantellops (right) with
Ludwig Huber (left).

Dennis is quality manager at the FDA Laboratory in San Juan, Puerto Rico, He is the author of FDA's SOPs and Laboratory Information Bulletins about using Excel spreadsheets. He is also FDA field investigator with national but also international experience. He answers most frequently asked questions

2. Validation master plan for equipment, computer systems, spreadsheets and networks (40 pages)

  • For effective, complete and consistent implementation
  • Includes chapter on Macro programs and Spreadsheets

3. Primer (45 pages): Using Macros and Spreadsheets in Regulated Environments

  • FDA requirements and inspection observations
  • Problems with spreadsheet programs and Macros
  • Policies and procedures for development and use of spreadsheets and Macros
  • Risk assessment and management: examples for risk factors and preventive actions
  • Design of spreadsheets for security, accurancy and integrity
  • Validation of spreadsheet calculations and Macros
  • Boundary testing, stress testing, error testing

4. Gap Analyses/Checklists

Gap analyses and checklists are Useful in preparation for audits and FDA inspections. They helps to avoid inspectional observations and warning letters. The checklist are updated on a regular basis to include suggestions from recent FDA guidance documents, industry task forces, FDA inspection findings and the author's own experience.
The package includes two checklists

  • Using Macros and Spreadsheets in Regulated Environments (E-156)
  • 21 CFR Part 11 - Electronic Records and Signatures (E-168)

5. Standard Operating Procedures

  • Training for GxP, 21 CFR Part 11 and Computer Validation (S-125)
  • Risk Assessment for Systems Used in GxP Environments (S-134)
  • 21 CFR Part 11 Scope and Controls (S-137) (UPDATE)
  • Development and Maintenance of Test scripts for Equipment Hardware, Software and Systems (S-237)
  • Development of requirement specifications for computer systems (S-253)
  • Revalidation of Software and Computer Systems (S-260) (NEW)
  • Change Control of Software and Computer Systems (S-262)
  • Validation of Macro Programs and other Application Software (S-263)
  • Validation of Spreadsheet Applications (S-264)
  • Using Macros and Spreadsheets in a Regulated Environment (S-265)
  • Retrospective Validation of Computerized Systems (269) (NEW)
  • Retention and Archiving of Electronic Records (S-315)
  • Data Back-up and Restore (S-317) (NEW)Access Rights to Computer Systems and Data (S-320) (NEW)

6. Spreadsheet Application Example: From Beginning to the End

Using a simple example, this document series guides users through the entire validation process from project planning through setting specifications, risk assessment, testing to the final validatio report.

  • Step-by-Step Validation (e-745-00) (NEW)
  • Validation Project Plan (e-745-01) (NEW)
  • Setting Requirement Specification (e-745-02) (NEW)
  • Risk Assessment (e-745-03) (NEW)
  • Supplier Assessment (e-745-04) (NEW)
  • Design Specification (e-745-05) (NEW)
  • Test Plan (e-745-06) (NEW)
  • Installation Qualification (e-745-07) (NEW)
  • Initial and On-going Performance Qualification (e-745-09) (NEW)
  • Validation Report (e-745-11) (NEW)

7. Real Excel spreadsheet example with validation documents (using standard Excel functions)

  • This example can be used as templates for other macros and spreadsheet calculations
  • Templates improve efficiency and ensure consistent implementation
  • For example:
    - Project schedule ( helps not to forget anything and for resource planning)
    - 21 User Requirement Specifications for Spreadsheets - example
    - Additional User Requirement Specifications for Macros - example
    - Test plan
    - 12 test scripts for functional testing, includes boundary testing, out of range testing
    - Test traceability matrices: tests vs. specifications, specifications vs. test cases
    - Test summary sheet
    - Inventory

8. Excel functions that help comply and reduce errors

Excel has a lot of functions that when used appropriately help to defend your data

  • Examples with user instructions, screen captures, etc
  • Input validation, tracking function, plausibility checks, conditional cell colors, printing file directory, path, file name, date
  • with VBA Code to Improve Quality and Compliance of Workbooks (E-131)

9. MD5 software example for hash values to demonstrate file integrity

  • Makes it easy to audit and verify that the spreadsheet is 'original'
  • Comes with validation documentation (DQ, IQ, OQ, PQ)

10. FDA Warning letters and 483 inspection observations and full inspection reports

  • FDA Warning letters and 483 inspection reports related to macros and/or spreadsheet calculations.
  • With full FDA report of follow up inspection demonstrating accepted corrective actions

11. Certificate for two years on-line updates through password protected website

  • FAQ's
  • more Macro examples coming
  • updates on regulations and guidance
  • Links to useful internet sites
  • register now for online updates (must have purchased the package)

12. Two FDA Laboratory Information Bulletins

Design and Validation of Spreadsheets

  • Part I: Multiple-user Workbooks
  • Part II: Single-user Workbooks

13. Regulations and Guidelines

The package comes with more than 50 regulations and guidelines. This includes FDA GxP regulations and all Part 11 guidance documents including the ones that have been withdrawn by the FDA.
They also include federal laws such as Sarbanes-Oxley, HIPAA and the E-sign Act.

Target Audience

  • Lab managers and personnel
  • Manufacturing managers
  • QA managers and personnel
  • IT managers and personnel
  • Analytical scientists
  • Validation specialists
  • Consultants
  • Teachers

Format/Price/Ordering

  • Format and Pricing
    - 1) Binder with CD, for $549.-
    - 2) Web download for $499.-
    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

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.

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 the Internet for the updates. That's why the author offers two year free on-line updates with the purchase of the quality package.

Updates include:

  • New regulations related to software and computer validation
  • New guidelines from agencies and industry task forces
  • Interpretations what the new regulations/guidance mean for spreadsheets and how to respond
  • New SOPs, checklists and examples, related to spreadsheets, if necessary
  • New FDA warning letters and 483 form inspectional observations.

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 spreadsheets 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 spreadsheet validation and compliance became a much more recognizable issue at higher levels of management. However currently there is no official guideline for spreadsheets. This Macro&Spreadsheet Quality Package will help to comply with these regulations

Topics related to compliance:

  • Procedures for validation: a fundamental requirement of all regulations.
  • Risk assessment procedures for stems used in GxP Environments, also useful for other regulations
  • Inspection reports and FDA warning letters,. They are useful to learn what auditors are looking at and how to avoid mistakes others made.
  • Procedures on how to train staff in a regulated environment.
  • Procedures and VBA scripts to ensure data integrity.
  • 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

Development and use of spreadsheets in regulated environments 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 validation requirements but none gives a full picture and details that are required for quick implementation.

This vendor neutral package is a single source covering all aspects. It is written by a single author who has more than 15 years practical international experience and understands qualification and validation 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:

  • What is it we should validate?
  • I have been using these spreadsheets since years, I know that they work, why should I start to validate?
  • How to overcome Excel® limitations for part 11?
  • What to do and document for risk assessment?
  • How does FDA's new approach for part 11 compliance impact Excel® applications?
  • Should we test standard Excel® functions?
  • Should we validate ad 'hoc' or 'one time use' Excel® spreadsheets?
  • What and how much should we document?
  • When can we delete e-records and when should we keep them?
  • How does the FDA validate spreadsheets for their own regulations?
  • How to ensure spreadsheet integrity for part 11 compliance?
  • How to apply risk based validation to Excel spreadsheets?

Why to go through the hassle and read several publications with lots of redundant information. With this best practices package book, targeted to developers and users of spreadsheet applications, 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.

Testimonials/References

 

 

The Feedback on the Labcompliance Spreadsheet Validation material has been received by e-mails. Labcompliance has permission to use the testimonials as references. Original e-mails are stored in the Labcompliance archive. Feedback also came the seminar "Validation and Use of Excel Spreadsheets in Regulated Environments" that is part of the Macro & Spreadsheet Quality Package and includes a subset of the Spreadsheet Quality Package material.

 

  • Feedback on the seminar included in the package
    Dr. Murray Rosenthal, Manager Reagent Technology Department, Alfa Wassermann Diagnostic Technologies, USA
    The seminar did exceed my expectations
    The presentation provided the details needed for us to set up a system to do spreadsheet validation. I thought the speaker had a very effective voice for this type of Webinar format. Ludwig kept our attention throughout the seminar. I believe this is one of the best webinars that I have participated in. This was very valuable to us. We appreciate the opportunity to participate. Thanks! (Ref 1072)
  • Feedback on the seminar included in the package
    Brian Lane, Booz Allen Hamilton/Centers for Disease Control and Prevention (CDC), Laboratory Quality Management Program, USA
    The seminar did exceed my expectations
    I knew little of this subject prior to the webinar, but now I think I possess the knowledge and tools I need. I think it is also significant that Dr. Huber's work is cited in FDA LIB 4317! We GREATLY appreciate all the documents we were able to download (Ref 1073)
  • Mr. Michael Capel, IT Director of Stryker, France.
    Feedback: The package did exceed my expectations..The set of documentation covers the entire scope of Excel spreadsheet utilization in a regulated environment (either in the bionder or the CDROM). Well done ! Totally professional !!. (Ref 1060)
  • Validation and Use of Excel Spreadsheets in Regulated Environments
    Feedback: The package did exceed my expectations. I used Excel throughout graduate school. I needed a guide to implement excel as a routine tool in my QA Lab. Excellent Seminar. Will definitely recommend to my peers. Worth many times the price.  (Ref 1008)
    Raymond Velez, Cooper Vision, USA, Puerto Rico.
  • Ms.Jenny Lesinski, Advion BioSciences, Inc., IT, USA (Ref 1025)
    Feedback: The information provided was eye opening. I was unaware that validating was such an easy process or that there was a reliable way to do it. Very Informative. Thank you so much!
  • Feedback on the seminar included in the package
    Validation and Use of Excel® Spreadsheets in Regulated Environments
    Feedback: The seminar did exceed my expectations.  Dr. Huber clearly knew his subject and communicated precisely what is needed to meet regulations. Great seminar. Ms. Janet Kingsley, WL Gore and Associates, Clinical Research, USA (Ref T-1047).
  • Ms. Aurelia Estela Rascon, CareFusion, Supervisor of Scientific Research Department, USA (Ref T-1043.
    Feedback: The seminar did exceed my expectations.  Because it achieved the purpose described. It provided very good references and it was very clearly presented. I liked this seminar because it did not have hidden information, or implied information. The information was very objective and useful.
    It was noticeable that Dr. Huber was knowledgeable, thank you for having experts presenting.
  • Feedback on the seminar included in the package
    Ms. Andrea Hands, WL Gore & Associates, Inc, , Testing and Validation Analyst, USA (Ref T-1041).
    Feedback: The seminar did exceed my expectations.  Dr. Ludwig Huber gave very practical, real world advice and suggestions. Having access to download the S.O.P.'s and documents on the spot was a huge plus. I really enjoyed the sharing of materials. This is something that can help right now. I have no further recommendations as I felt this was one of the best web seminars I have attended
  • Feedback on the seminar included in the package
    Dr. Ron Kneisler,  Albermarle Corporation, QA Advisor, Quality Department, USA (Ref T-1040).

    Feedback: The seminar did exceed my expectations.  Excellent knowledge and a lot covered in the hour. Very good seminar.
  • Mr. Damon Talley, SAFC, QA Supervisor, QA, USA (Ref T-1039).
    Feedback: This was exactly the kind of start off information we were looking for. We are just beginning to consider validation of Excel spreadsheets. Very good information. Really liked the references so we can see where to pursue additional guidance.
  • Feedback on the seminar included in the package
    Ms. Dionne Boyce, WL Gore & Associates, Inc, , Validation Analyst, USA (Ref T-1038).

    Feedback: The seminar did exceed my expectations.  Dr. Huber did not just provide high level information but practical real world advice on methods to use to meet spirit of regulations

Extracts from FDA Inspectional Observations and Warning Letters

  • Failure to have an adequate validation procedure for computerized spreadsheets used for in-process and finished product analytical calculations. The current validation procedure uses only the values that result in within specification findings, aberrant high findings, and aberrant low findings [21 CFR211. 165(e)]. For example, SOP 644.00, QA/QC Spreadsheet Validation, is deficient in that only a small range of values are being used to challenge computerized spreadsheet mathematical calculations.
  • Failure to use fully validated computer spreadsheets to calculate analytical results for in-process and finished product testing [21 CFR 211.165(e)]. For example, the computer spreadsheets used to calculate analytical results for... have not been validated.
  • Failure to validate computer software used as part of the quality system for its intended use according to an established protocol as required by 21 CFR 820.70(i). For example: Software such as Excel, Access, and Word used to create and maintain data bases (rejects, complaints, and concessions) and electronic documents, is not validated.
    In their response dated April 3, 2000, your firm stated that by May 31st, they will have identified what software is used for data processing, and identified a method or methods for validation and/or verification of the software.
  • You failed to investigate the failure of the ... when operating in MS Access. The system locks up at random and it is unknown whether the software which controls the .... during off of MS Excel, could be similarly affected.
  • Failure to validate computer software used as part of the quality system for its intended use according to an established protocol as required by 21 CFR 820.70(i). For example, the data in the Excel spreadsheet identified as a "Hit List" of top non-conforming components contains 16 record counts for part number 8601618 DC converter failures compared to 18 record counts for part number 860168 DC converter failures in the dbase database. The spreadsheet is used for management review of component suppliers for all components.

The author

Picture of Ludwig Huber

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