# Presentation: 076832

## 21CFR Part 11  FDA Public Meeting  

**Comments **
**Presented by:**
**M. Rita Geiger**
**President/CEO **
**InfoStrength, Inc.**

## Introduction

**InfoStrength **
**Services **
**Quality and regulatory compliance strategy development and implementation**
**Audit and assessment of computer systems and quality programs**
**Training and consulting services**
**Custom Software Development**
**Web-enabled applications that meet regulatory compliance needs**
**Products - InfoStrength SES**
**Web-based compliance management **
**Knowledge management and collaboration among employees and third parties**

**M. Rita Geiger**
**President/CEO of InfoStrength**
**Over 14 years of regulatory & technology expertise **
**Over 10 years of Standards and Safety Requirements development experience **
**Participant in National and International Standard committees**
**Education:**
**B.S. in Electrical Engineering with focus in Computer Science from Polytechnic University**
**M.B.A. from The Fuqua School of Business at Duke University**

- Confidential  © 2004 InfoStrength, Inc.

## Agenda

**Regulatory Compliance Landscape**
**Implementation Gap Overview**
**Part 11 Compliance Challenges**
**Definitions**
**Processes**
**Technological Controls**
**Closing the Implementation Gap**

- Confidential  © 2004 InfoStrength, Inc.

## Regulatory Compliance Landscape

- Confidential  © 2004 InfoStrength, Inc.

## Implementation Gap Overview

**Addressing Risks **
**System Safety Risks **
**Regulatory Risks**
**Legal Risks**
**Business Risks **
**	****Compliance Response:**
**Prescriptive Regulations **
**Confusing Guidance**
**Precise Checklists **
**Prescribed Processes**
**Specific Controls**

**FDA Concerns**
**Protect Public Safety**
**Permit Use of Electronic Technology**

**Industry Concerns**
**Comply with 21CFR Part 11**
**Use Electronic Records**
**Decrease Compliance Costs**

- Confidential  © 2004 InfoStrength, Inc.

## Part 11 Compliance Challenges

**	**
**	****21 CFR Part 11 Compliance**** = ****	**
**Interpretation**** ****+**** ****Process ****+ **
**Controls ****+ ****Team**** + **
**Documentation ****+ ****Validation**
**	**

- Confidential  © 2004 InfoStrength, Inc.

## Part 11 Compliance Challenges

**Interpretation**
**Definitions**
**Application of Part 11**
**Electronic Records **
**Closed v. Open Systems**
**Legacy Systems**

- Confidential  © 2004 InfoStrength, Inc.

## Part 11 Compliance Challenges

**Processes, Documentation, & Validation**
**Processes**
**SOPs**
**Guidance**
**Company Common Practices**
**Risk Analysis**
**Methodology**
**Validation **
**Methodology**

- Confidential  © 2004 InfoStrength, Inc.

## Part 11 Compliance Challenges

**Controls**
**11.200 Electronic signature **
**Use and application of Electronic Signatures **
**11.300 Controls for Identification Codes/Passwords**
**(d) Use of transaction safeguards to prevent unauthorized use of passwords and/or identification codes, and to detect and report in an immediate and urgent manner any attempts at their unauthorized user to the system security unit, and, as appropriate, to organizational management**

- Confidential  © 2004 InfoStrength, Inc.

## Part 11 Compliance Challenges

**Team**
**Knowledge**
**Regulatory **
**Business**
**Resources **
**Process / Project Management**
**Method expertise**
**Technology Expertise**
**Infrastructure**
**Tools**
**Training**
**Top Down / Bottom Up Support **

- Confidential  © 2004 InfoStrength, Inc.

## Closing the Implementation Gap 

**21 CFR Part 11 Compliance**** = **
**Interpretation ****+**
**Process ****+ **
**Controls ****+**
**Team ****+**
**Documentation ****+**
**Testing/Validation**** ******** **

**Compliance Strategy**

- Confidential  © 2004 InfoStrength, Inc.

## Thank You

**If you have questions, **
**Please contact me at**** **_**[rgeiger@infostrength.com](mailto:rgeiger@infostrength.com)**__** or**_
**(919) 573-6132**

- Confidential  © 2004 InfoStrength, Inc.