Computer System Validation

Strategies for Achieving and

Maintaining Part 11 Compliance

in Today's Current Practices

Gary D. Kimmel

Senior Director

Quality Assurance and

Compliance Service

Today’s Presenter

Introductions

• Introduction of Team Members

• Pilgrim Software

• Nancy Defilippis

• Jim Dalton

• Jeff Fenske

• Business Intelligence Solutions

• Gary Kimmel

• Jon Nugent

What we’re covering today:

Perspective from the FDA: Computer Validation

Overview of Computer Systems Validation

What System to Validate

Validation Requirements

Computerized System Validation Documentation

A Practical Approach to Implementing CAPA

Perspective from FDA

Computer Validation -

A documented process that

demonstrates a system was

developed, implemented,

operated, and maintained

in a controlled manner and

results in assurance that

the system consistently

meets specifications and is

suitable for intended use.

Overview of

Computer Systems Validation

• Computer System - Includes hardware, software,

peripheral devices, personnel, and documentation; e.g.,

manuals and Standard Operating Procedures.

The scope of validation includes implementation of

hardware, software, policies, procedures, and training of

personnel on automated information systems (AIS) that

house FDA-regulated data.

Validation Requirements

• Guidelines leave Validation open to interpretation

• Developing and following internal standards

• Auditable to standards

• Personal accountability

• Time and resource constraints needed for

execution

• Volume of documentation

What Systems to Validate

The validation of computer

systems performing

regulated operations provides

confirmation by examination

and provision of objective

evidence.

Computer system

specifications conform to

user needs and intended

uses, and that all

requirements can be

consistently fulfilled.

Installation Qualification (IQ)

• The IQ includes the verification of the

installation requirements, verification of the

equipment specifications, and verification of

the actual installation.

• The IQ protocol should verify that the system

meets the System Design Specification

expectations.

Operational Qualification (OQ)

• The OQ is tied to the Functional

Requirements Specification (FRS). All

functions identified in the FRS must

be tested. Testing includes Unit

Testing and Integration Testing.

Performance Qualification (PQ)

• The PQ is based on the User

Requirements Specification (URS).

Since these tests provide evidence for

user acceptance, trained key users of

the system must be involved in PQ

testing and in review and approval.

Computer System Validation

Documentation

• Computer System Validation SOPs

– Document Management

• SOPs and Forms / Reports

Management

– Security (Logical and Physical)

– Employee Training

– Backup and Restore

– System testing (Validation and

Verification)

– Change Control and Configuration

Management

– Problem Resolution

– Periodic Review and Monitoring

– Disaster Recovery

A Practical Approach to

Validation Document Management

In the current paper-based

validation process, tracking

validation status of any

system, equipment or

instrument is time

consuming and very often

submerged in a sea of

paper.

Overall, validation managers

and supervisors spend an

inordinate amount of time

searching out both

validation status and

documents during the

process.

Standard Operating Procedures (SOPs)

Audits

• Purpose is to identify processes,

procedures, and objective evidence of a

quality system and inspect for

compliance.

• The audit typically verifies the adequacy

of controls generally focusing on

documented processes, procedures,

and existing documentation for all

system life cycle activities.

• Should be completed for a vendor that

will provide a product or hosting

services

Remediation Activities

• Remediation activities

are those tasks that

are required to be

completed to amend

previous Validation

activities (commonly

as a result of an audit)

Who: Who is involved with the

CAPA Process.

What: What events trigger the

CAPA process.

When: When do you conduct the

CAPA.

Why: Why is the CAPA

performed.

Where: Where do you start the

CAPA process.

.

Corrective and Preventive Action

• In most organizations, the Quality

Assurance and Compliance

Department (QA) will lead the CAPA

process along with all applicable

departments (Operations,

Manufacturing and/or Packaging

Maintenance, QC, etc.) involved in the

problem(s) and/or how to rectify the

problem.

• QA has the final responsibility and

authority to sign off the CAPA Report.

CAPA

CAPA System Triggers:

There

numerous

examples of

what events

can trigger a

CAPA

• Consumer Complaint(s)

are received for the

same problem(s):

Product, Materials,

Labeling, Contamination

• Plant or FDA Product

Recall initiation

• Internal QA Audits find

major system

discrepancies

CAPA System Measurement

• To get to the

root cause of

the problem,

fix it, and

assure that it

never happens

again!

CAPA System Analysis

The CAPA is

completed when

all systems,

process,

specifications,

validation,

training, etc. have

been signed off by

Quality Assurance.

CAPA System Improvement

Successful Computerized Validation

• How will you know if you have

had a successful CAPA and

Validation effort?

– A successful implementation

with no “bugs” introduced to

your Production environment

– A well documented path

from the initial validation to

the change control process

– A successful audit with no

major compliant or findings

References

• Home page - http://www.pilgrimsoftware.com

• http://www.busintellsol.com

• FDA Glossary of Terms

http://www.fda.gov/ora/inspect_ref/igs/gloss.html

• Guidance for Industry Part 11, Electronic Records; Electronic

Signatures – Scope and Application

http://www.fda.gov/cder/guidance/5667fnl.htm

• 21 CFR Part 11 Electronic Records, Electronic Signatures

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CF

RSearch.cfm?CFRPart=11

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