Source: http://labcompliance.com/books/macros/default.aspx
Timestamp: 2017-09-22 20:30:28
Document Index: 125159024

Matched Legal Cases: ['art11', 'art 11', 'art 11', 'art 11', 'art 11', 'art 11', 'art 11', 'art 11', 'art 11', 'art 11', 'art 11', 'art 11', 'art 11']

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
Using Excel Spreadsheets in Regulated Environments
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.
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.
New or updated features/documents include
Audio seminar: Validation and Use of ExcelÂ® 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: 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
SOPs for development, validation and use of Macros and Spreadsheets for highest efficiency and consistency.
SOPs for validation, change control and training.
Procedures for risk assessment and limited access.
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).
Interactive audio seminar for fast and intuitive familiarization with the topic, with FDA's Dennis Cantellops answering most frequently asked questions.
Validation examples from project planning to validation report
Primer for extensive background and reference information.
FDA 483 observations, warning letters and full follow up inspection report (EIR) describing corrective actions.
Extensive gap analysis/checklist to prepare for successful inspections, with gaps for risk assessment.
Excel Macro example with validation documentation such as project plan, inventory list, requirement specifications, test plan, traceability matrix and test scripts for fast implementation.
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).
Special Excel operating manual with functions dedicated to assist for GxP and Part 11 compliance.
Two year on-line updates to stay on top of ever changing regulations -
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
1. Interactive Seminar with FDA's Dennis Cantellops and Ludwig Huber
Recommendations from the new GAMPÂ®5 and Annex 11
How FDA is validating using Excel for compliance
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)
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)
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 validation 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
- 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
- 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
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
more Macro examples coming
updates on regulations and guidance
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
- 1)CD for $549.-
- 2) Web download for $499.-
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.
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.
New SOPs, checklists and examples, related to spreadsheets, if necessary
New FDA warning letters and 483 form inspectional observations.
Click here to go to the update site (requires access information)
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
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
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.
I have been using these spreadsheets since years, I know that they work, why should I start to validate?
How to overcome ExcelÂ® limitations for Part 11?
What to do and document for risk assessment?
How does FDA's new approach for Part 11 compliance impact ExcelÂ® applications?
Should we test standard ExcelÂ® functions?
Should we validate ad 'hoc' or 'one time use' ExcelÂ® spreadsheets?
How does the FDA validate spreadsheets for their own regulations?
How to ensure spreadsheet integrity for Part 11 compliance?
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.
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
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)
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.
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.
It was noticeable that Dr. Huber was knowledgeable, thank you for having experts presenting.
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.