The MCC AIM System Validation Protocol

FDA and NIST Documents Referenced by MCC Validation Plan

Table of Contents

Purpose and Overview

1.1. System Identification

1.1.1. Hardware, Primary (customer specific)

1.1.2. Hardware, Secondary (customer specific)

1.1.3. Software, Primary Operating

1.1.4. Software, Applications

1.2. Purpose of Validation

1.3. System Functions

1.4. Protocol Structure

1.4.1. Sections

1.4.2. Forward references

1.4.3. Backward references

1.5. FDA and NIST Documents Referenced by MCC's Validation Plan

2. Validation Scope (CPG 7132a.11) (Guide_CSDP, Section III.C)

3. Validation Documents (Guide_CSDP, Section III.C.5)

3.1. Computer Validation Plan Approval (Guide_CSDP, Section IV.D.4)

3.1.1. Validation Personnel

3.1.2. Signatures

3.1.3. Approvals

3.2. Computer Validation Project Approval (Guide_CSDP, Section IV.D.4)

3.2.1. Validation Personnel

3.2.2. Signatures

3.2.3. Approvals

3.3. Computer Validation Report (Executive Summary)

4. Vendor Audit Document (Guide_CSDP, Section III.C.6) (CPG 7132a.12)

5. Requirements Definition Document (SDA96, Chapter 3)

5.1. Functional Requirements Specifications

5.1.1. User Requirements Document (Base System)

5.1.2. User Requirements Document (Version 2.5 Upgrade, Base System)

5.1.3. User Requirements Document (Version 2.67 Upgrade from version 2.5)

5.1.4. User Requirements Document (Customer Specific Modifications)

5.2. System Purpose and Scope (Guide_CSDP, Sections III, IV)

5.2.1. System Purpose

5.2.2. Definition of Hardware (Guide_CSDP, Section III A-C)

5.2.3. Definition of Software (Guide_CSDP, Section IV A-B)

5.3. Assumptions and Exclusions (Guide_CSDP, Sections III.C and IV.D)

5.4. Intended Functions (Guide_CSDP, Sections III.A & IV.D) (CPG 7132a.08)

5.4.1. Mechanical Functions

5.4.2. Electrical and PC Functions

5.4.3. Software Functions

5.5. Test Protocols (Guide_CSDP, Sections III.C, III.C.5, IV.D.2, & IV.D.4)

5.5.1. Development Test Program and Test Results

5.5.2. Qualification Test Program and Test Results

6. System Design (CPG 7132a.15) (SDA87, Chapter 4) (Design)

6.1. Component Evaluations and Prototypes

6.1.1. General System Design (Base System)

6.1.2. General System Design (Version 2.5 Upgrade, Base System)

6.1.3. General System Design (Version 2.67 Upgrade from version 2.5)

6.1.4 General System Design (Customer Specific Modifications)

6.1.5. Detailed System Design (Base System)

6.1.6. Detailed System Design (Version 2.5 Upgrade, Base System)

6.1.7. Detailed System Design (Version 2.67 Upgrade from version 2.5)

6.1.8. Detailed System Design (Customer Specific Modifications)

6.1.9. Technical Software and Hardware Specifications

6.2. Flowcharts

6.3. Algorithms

6.4. Proposed Platform and Language Choices (Guide_CSDP, Section IV.B)

6.5. Proposed File and Record Layouts

6.6. Module Descriptions

6.7. User Interface (Do_It)

7. System Development (CPG 7132a.15) (SDA87, Chapter 2)

7.1. Project Specifications (Customer Specific)

7.1.1. Project Summary

7.1.2. Vendor Price Quote(s), Terms and Conditions

7.1.3. Summary Justification(s)

7.1.4. Capital Equipment Authorization(s)

7.1.5. Purchase Order(s)

7.1.6. Project Layout

7.1.7. Vendor Employee Task Assignment Sheets

7.1.8. Vendor Organizational Chart

7.2. Source Code (Guide_CSDP, Section IV.C.1)

7.3. Development History (MCC Internal)

7.3.1. AIM Development History

7.3.2. AIM Installation History

7.3.3. AIM Software Revision Log

7.4. System Development Testing (NIST Ref., Ch. 2,3), (SDA87, App. C), (SDA96, Section 9)

7.4.1. Testing Phases

7.5. Bug Reports

7.5.1. Bug Report submittal forms are found in SOP # 1010.

7.6. Enhancement Requests

7.6.1. Enhancement Request submittal forms are found in SOP # 1010.

7.7. Component Specifications

7.8. Installation and Maintenance Instructions

8. Standard Operating Procedure Verification (SDA87, Preface)

8.1. User Guide (Guide_CSDP, Sections III.C.2, IV.B.10, V.B, & V.F)

8.2. Training (21 CFR 211.25)

8.3. Calibration (Guide_CSDP, Section III.B.3) (21 CFR 211.68(a))

8.4. Configuration Management (SDA96, Section 3)

8.5. Error Notification and Change Control (Guide_CSDP, Section III.C.6 & IV.C.2)

8.6. Periodic Review (Guide_CSDP, Sections III.C.6 & IV.D.5) (CPG 7132a.07)

8.7. Preventive Maintenance (Guide_CSDP, Section III.B.5) (21 CFR 211.67)

8.8. Environmental Considerations

8.9. Hardware Maintenance

8.10. Software Maintenance

8.11. Virus Checking

8.12. Long Distance Support

8.13. Security (21 Guide_CSDP, Section IV.C.2) (CFR 211.68(b))

8.14. Backup / Archiving (Guide_CSDP, Section V.C & VI.B.4)

8.15. Disaster Recovery (Guide_CSDP, Section V.G)

8.16. Corporate Contingency Plan

8.17. Warranty and Post-Warranty Maintenance Contracts

9. MCC SOP listing

10. Installation Qualification (SDA87, Chapter 5)

10.1. Installation Qualification Checklist (Guide_CSDP, Section III.B.1)

10.2. List of System Components and Modules (Guide_CSDP, Sections III & IV)

10.2.1. Sensors

10.2.2. Amplifier / Signal Conditioner

10.2.3. Computer

10.2.4. Software

10.3. System Diagram (Guide_CSDP, Section III.A.5)

10.4. Glossary

10.5. Vendor Literature (Guide_CSDP, Section III)

11. Operational and Performance Qualification (Test Protocols)

(NIST Reference, Chapters 2,3), (SDA96, Chapter 6, Pages 21-23), (SDA96, Section 9)

11.1. Definitions

11.2. Validation Test Plan

11.2.1. Objective

11.2.2. Evaluation and Recording of Test Results

11.3. System OQ/PQ Test Allocation

11.4. Installation Specific Tests - Protocol Title List

11.5. Signature Table (Guide_CSDP, Section IV.D.4)

11.6. Installation Specific Tests - Protocol Results Worksheet (SDA87, Ch. 6, P. 19 & Ch. 7)

11.7. Executed Test Protocols (SDA87, Chapter 7)

Appendixes

Appendix I. AIM System Requirements Documents

Appendix II. AIM System Design Documents

Appendix III. AIM System Development Documents

Appendix IV. Standard Operating Procedures

Appendix V. Installation Qualification Documents

Appendix VI. Executed Test Protocols

Appendix VII. AIM System User Manual (white binder)

Appendix VIII. AIM System Technical Documentation (blue binder)

FDA and NIST Documents

Referenced by MCC Validation Plan

The MCC Validation Plan was developed as a practical approach to validation based on the Agency's regulations and guidelines.

Almost every subject in the Validation Plan is referenced by at least one of the following FDA documents:

21CFR210 = Code of Federal Regulations, Title 21 - Food and Drugs. Part 210 - - Current Good Manufacturing Practice In Manufacturing, Processing, Packing, Or Holding Of Drugs; General

21CFR211 = Code of Federal Regulations, Title 21 - Food and Drugs. Part 211 - - Current Good Manufacturing Practice For Finished Pharmaceuticals

21CFR820 = Code of Federal Regulations, Title 21 - Food and Drugs. Part 820 - - Quality System Regulation

CPG 7132a.11 = Sec. 425.100
Compliance Policy Guide - Computerized Drug Processing; CGMP Applicability to Hardware and Software

CPG 7132a.12 = Sec. 425.200
Compliance Policy Guide - Computerized Drug Processing; Vendor Responsibility

CPG 7132a.15 = Sec. 425.300
Compliance Policy Guide - Computerized Drug Processing; Source Code for Process Control Application Programs

CPG 7132a.07 = Sec.425.400
Compliance Policy Guide - Computerized Drug Processing; Input/Output Checking

CPG 7132a.08 = Sec. 425.500
Compliance Policy Guide - Computerized Drug Processing; Identification of "Persons" on Batch Production and Control Records

Design = Design Control Guidance For Medical Device Manufacturers. CDRH, FDA, March 1997.

Do_It = Do It By Design. An introduction to Human Factors in Medical Devices. CDRH, FDA, December 1996.

Guidance = Guidance for Industry. General Principles of Software Validation. CDRH, FDA, June, 1997

Guideline = Guideline on General Principles of Process Validation. CDER, FDA, February 1993.

Guide_CSDP = Guide to Inspection of Computerized Systems in Drug Processing. FDA, February 1983.

NIST Reference = Reference Information for the Software Verification and Validation Process. NIST Special Publication 500-234, March, 1996.

SDA87 = Technical Report: Software Development Activities. Reference Materials and Training Aids for Investigators. FDA, July 1987.

SDA96 = Technical Report: Software Development Activities. Reference Materials and Training Aids for Investigators. Second Edition. FDA, Draft - October 1996.

Glossary = Glossary of Computerized System and Software Development Terminology. FDA, August 1995.

GL = Guideline On General Principles of Process Validation, CDER