In-house Compliance Workshop

Learn through case studies and direct interaction with pears and the speaker.
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Compliance Workshop 107

Validation and Use of Excel in Regulated Environments

Comply with GxPs, Part11, HIPAA, SOX and other regulations.

Course objectives

• Understand regulatory requirements for using Excel spreadsheets
• Understand how to design and develop effective Excel spreadsheet for compliance
• Learn how to build security, accuracy and integrity into Excel spreadsheets
• Learn how to effectively validate Excel spreadsheets
• Learn how to document Excel spreadsheets for FDA and other regulations

Contents Overview

• Regulatory requirements for spreadsheets; FDA Part 11, GxP, HIPAA, Sarbanes-Oxley.
• Typical compliance problems with spreadsheets
• Recommendations from GAMP® 5
• Recommendations from FDA's two Information bulletins for: single users and multiple users of spreadsheet applications.
• How to design spreadsheets for compliance.
• How to ensure and validate spreadsheet integrity.
• When, what and how much to test?
• Testing 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
• Examples from manufacturing, laboratories and offices

Detailed Agenda

 

FDA and International Requirements and Enforcement

• FDA regulations: CFR Parts 211, 58, 820, and Part 11
• Examples of FDA 483's and Warning Letters
• International regulations and guidelines: EU GMPs, Annex 11, PIC/S
• Industry guides: GAMP® 5, PDA, IEEE
• Sarbanes Oxley (SOX) and HIPAA
• 'Out of the Box' Excel deficiencies for compliance
• Alternative solutions for compliance

Planning for Efficient Compliance

• Developing a compliance policy
• Developing a master plan and SOPs
• Search for and documenting all spreadsheet Installations 
• Standardizing hardware, software, documentation
• Train developers and users
• Including spreadsheet applications in regular audits

Design of Excel Spreadsheets for Part11/GxP Compliance

• Design for error detection
• Design with integrity in mind
• Using MD5 checksums to document spreadsheet and data integrity
• Design for authenticity
• Design for spreadsheet and data security
• Use the round formula for rounding and statistics
• Building audit trail into Excel spreadsheets

Validation of Excel Spreadsheets

• Developing a project validation plan
• Risk based validation lifecycle for Excel Spreadsheets
• Writing specifications
• Design and code review for complex spreadsheets and Macros
• Testing during development and  during installation
• Testing of Excel standard/native functions yes/no?
• Validation and documentation of VBA scripts

Compliance During On-going Use

• Regular checks of spreadsheets
• Training of new users
• Maintain compliance during changes
• Lear how FDA complies with their own regulation
• Documentation for Part 11compliance

Putting it all together for different applications

• Going though complete examples: from design to retirement
• Interactive template for calculations
• Data import from automated instruments
• Documenting training records
• Data base for clinical trials
• Using Excel in development departments
• Applications in manufacturing

Collaborative Exercises, Discussions and Examples

Practical examples, case studies and collaborative exercises will be dispersed into and between the presentations. At least 50% will be dedicated to practical sessions with life examples. The outcome will be made available for all attendees on a special workshop reference website. Practical sessions include:

• Applications for regulated/non-regulated spreadsheet applications
• Developing a validation plan
• Writing specifications
• Identify risk level for different spreasheets
• Developing a test plan
• Documenting installation
• Functions to be tested yes/no?.
• Developing summary documentation

10+ Reference Documents for Easy Implementation

This material will help  attendees to quickly implement what they have learned in the seminars

• SOPs:
  - Validation of spreadsheet applications
  - Development and use of spreadsheets in regulated environments
  - Change control of software and computer systems
• Checklist for Macros and Spreadsheet applications
• Examples
  - Spreadsheet validation project schedule
  - Requirement specification
  - Installation documentation
  - Traceability matrix
  - Protocols for functional testing
  - Summary test sheet
• Article (Published in Biopharm): Using Macros and Spreadsheets in Regulated Environment
• Software and validation package: File integrity check with MD5 Hash Calculations
• FDA 483 form inspectional observations, establishment inspection reports and several warning letters with deviations related to Excel

Who should attend

• All developers and users of spreadsheet applications
• Validation specialists
• QA managers and personnel
• Production and lab managers
• Regulatory affairs
• Training department
• Documentation department
• Consultants

About the speaker: Dr. Ludwig Huber

• Chairman, presenter and panel discussion member at US-FDA Industry Training sessions and conferences
• Team and/or review member of PDA's task forces "21 CFR Part 11", of US-FDA internal documents, and of the GAMP special interest group on Laboratory Equipment
• Presenter of the Year of the Institute for Validation and Technology
  Director and chief editor of www.labcompliance.com, the global on-line resource for validation and compliance issues.
• Author of the books “Validation and Qualification in Analytical Laboratories, and "Validation of Computerized Analytical and Networked Systems", Interpharm Press
• For more information on Ludwig Huber, click here.

Dr. Ludwig Huber is a frequent presenter at IVT conferences and has been awarded as the 'Presenter of the Year' out of 170 speakers. This photo is from IVT's conference on Network Qualification with Ludwig Huber as plenary speaker.