Macro and Spreadsheet Quality Package

Using Spreadsheets in Regulated Environments

Intro

• Are you using Excel in a regulated environment, e.g., GLP/GCP/GMP/Part11/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 laboratories and production environment. They need to be validated and comply with 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.

 

January 2006: Version 2.3 released

New or updated features/documents include

• Audio seminar: Validation and Use of Excel® Spreadsheets in GLP/GMP and Part 11 Environments.
• Primer: 45 pages, with updates reflecting FDA's new approach for Part 11.
• SOP: Retention and Archiving of Electronic Records. Procedures to ensure integrity of e-records.
• SOP: Development and maintenance of equipment hardware, software and systems
• Development and maintenance of test scripts for equipment hardware, software and systems
• Development of requirement specifications for computer systems
• 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
• FDA Laboratory information bulletin, Part 2: Spreadsheet design, verification, use and storage of single-User workbook files in the US FDA Laboratories. Not publicly available from the FDA website

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

• Part I: Multi-User Workbooks
• Part II: Single User Workbooks (New)

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 video for fast and intuitive familiarization with the topic.
6. Primer for extensive background and reference information.
7. FDA 483 observations, warning letters and full follow up inspection report (EIR) describing corrective actions.
8. Extensive gap analysis/checklist to prepare for successful inspections, with gaps for risk assessment.
9. Excel Macro example with validation documentation such as project plan, inventory list, requirement specifications, test plan, traceability matrix and test scripts for fast implementation.
10. 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).
11. Special Excel operating manual with functions dedicated to assist for GxP and part 11 compliance.
12. Two year on-line updates to stay on top of ever changing regulations -
    Register now.
13. 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 Video

• 50 Video clips on CD
• On MS Powerpoint, comes with Powerpoint Viewer
• Contents
  - FDA requirements and inspection findings
  - Problems with spreadsheet programs and Macro
  - Policies and procedures for development and use of spreadsheets and Macros
  - Strategy and example for risk assessment and management
  - Validation of Macro programs
  - Validation of spreadsheet calculations
  - Case study using functions built in spreadsheet to increase reliability, integrity, security

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
• Risk assessment and management: examples for risk factors and preventive actions
• 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. Helps to avoid inspectional observations and warning letters. The checklist is 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 (7 pages)
• 21 CFR Part 11 - Electronic Records and Signatures (8 pages)

5. Standard Operating Procedures / Test procedures

• Validation of Macro Programs and Other Application software
• Using Macros and Spreadsheet Applications in a Regulated Environment
• Change Control of Computer Systems
• Verifying limited access
• Risk assessment for part 11
• Training for GxP and computers
• Development and maintenance of test scripts for equipment hardware, software and systems
• Development of requirement specifications for computer systems
• 21 CFR Part 11 Scope and Controls

6. 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

7. 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

8. 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)

9. 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

10. 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)

11. Two FDA Laboratory Information Bulletins

Design and Validation of Spreadsheets

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

12. 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: Binder, CD
• Size: More than 1000 pages, when printed
• Price: US$ 499.- (includes shipping and free on-line update for two years).
• VAT will be added for EU countries.
• Availability: Worldwide, shipment within one working day
• 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 networks and how to respond
• New SOPs, checklists and examples, related to network qualification, 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.
• Procedure Risk Assessment for Systems 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.

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

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