FDA Validation Testing · The FDA requires that medical device manufacturers, pharmaceuticals manufacturers, biotech companies, biologic developers, and other FDA-regulated industries

FDA Validation Testing

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Introduction

Today, with increasing regulatory scrutiny and

FDA regulations, more companies are seeking

solutions to compliance requirements.

Pyramid’s experienced consultants are well

equipped to help. We optimize the time and

cost of validation by applying a risk-based

approach to each system. We also offer

a wide range of automated tools as part

of the consulting engagement to provide

maintainable compliance.

FDA 21 CFR Part 11 Explained

Title 21 CFR Part 11 is the part of Title 21 of the

Code of Federal Regulations that establishes

United States Food and Drug Administration

(FDA) regulations of electronic records and

electronic signatures (ERES). Part 11, as it is

commonly called, defines the criteria by which

electronic records and electronic signatures

are considered to be trustworthy, reliable, and

equivalent to paper records.

The FDA requires that medical device

manufacturers, pharmaceuticals

manufacturers, biotech companies, biologic

developers, and other FDA-regulated industries

comply with regulations and implement

controls.

Validation vs. Verification

Validation: “The assurance that a product,

service, or system meets the needs of the

customer and other identified stakeholders.

It often involves acceptance and suitability

with external customers. Contrast with

verification.”

Verification: “The evaluation of whether or

not a product, service, or system complies

with a regulation, requirement, specification,

or imposed condition. It is often an internal

process. Contrast with validation.”

Challenges in Validation and Testing

Validation and testing of FDA regulations

present unique challenges. Organizations

that create custom computer systems are

responsible for validating those systems,

but the FDA and other regulatory bodies are

requiring that organizations that purchase

computer systems for GMP, GLP, and

GCP environments verify that the software

manufacturer has Quality Systems in place to

test their software, track software issues, and

control software releases.

Pyramid Validation and Testing Strategy

Implementing a compliance program requires

focus, consistency, and a methodical

approach. Whatever the exact shape of its

implementation methodology, a company

must take an approach that accomplishes

the steps detailed in the chart below. The

best known industry guidance available is

probably the GAMP Guide. Now in its fifth

edition and known simply as GAMP, this

guide gives practical advice on how to satisfy

regulatory requirements. Pyramid follows the

FDA-recommended GAMP methodology and

other good practices for all validation services.

The following diagram illustrates Pyramid’s

validation methodology.

DESIGN QUALIFICATION (DQ) • User Requirements Specifications

• Facets of the Process or Equipment are Operating Correctly

• Process or Equipment Performs as Intended in a Consistent Manner Over Time

• Components Manufactured to the Design Criteria

• Process or Equipment Correctly Installed• Components and Documentation Nedded Are Installedand In PlaceINSTALATION QUALIFICATION (IQ)

OPERATIONAL QUALIFICATION (OQ)

SYSTEM

PERFORMANCE QUALIFICATION (PQ)

COMPONENT QUALIFICATION (CQ)




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FDA VALIDATIONTESTING

VALIDATION METHODOLOGY


Design Qualifications

Design review is a primary tool for managing and evaluating

development projects. Design reviews are documented,

comprehensive, and systematic examinations of a design to

evaluate the adequacy of the design requirements, evaluate

the capability of the design to meet the user requirements

specification (URS), and identify gaps and problems.

The scope of design qualification includes:

• Achievement of URS requirements

• Conformation to the life cycle model requested in GAMP

• Compliance with the VMP

• Availability and validation of required utility services

• Specification of required support documentation

• Ability to calibrate system

• Ability to maintain system

• Definition of operation staff training requirements

• Operation of the system in a manner safe to both

product and staff

• Conformation of the system to all applicable

national standards and guidelines

Installation Qualifications

The goal of IQ testing/inspections is to verify that all components

related to the installation are installed and work as specified,

and that all required components and documentation needed for

continued operation are installed and in place.

The scope of IQ testing/inspections includes:

• All component parts

• Installation is as specified

• Description of each part of the validated product process

• Description of the operational function

• Electrical installation qualification (IQ) compliance

• Verification that all alarms and visual displays are functional

• Confirmation that the correct versions and updates of the

software are installed

• Verification that model and serial numbers are correct

• Review of all calibration certificates

• Verification of signal continuity

• Verification of ambient conditions

• Verification of maintenance documentation or logs

DESIGN REVIEWS ARE DOCUMENTED, COMPREHENSIVE, AND SYSTEMATIC EXAMINATIONS OF A DESIGN

Operational Qualifications

Operational qualification ensures that all aspects of the

operational solution, including processes, procedures and all

equipment included in the overall solution are operating correctly.

The scope of OQ testing/inspections must include but is not

limited to:

• All loop installations

• Description of each part of the validated product process

• Description of the operational function

• Testing of alarms

• Testing of interlocks and permissive conditions

• Testing of database or data storage integrity

• Testing of report generation and event chronicle

• Verification of the functionality of the equipment

• Challenge of software, where required

• Review of system functionality to verify compliance

with 21 CFR Part 11

• Testing of security levels to prevent unauthorized access

• Testing to verify and document power loss recovery

• Testing of all interfaces

• Testing for electromagnetic interference and compatibility





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Performance Qualifications

Performance qualification (PQ) is implemented after successful

completion of IQ and OQ steps. Testing is targeted at verifying

the delivery of the performance specified in the user requirement

specification (URS).

PQ is used to establish and/or confirm:

• Definition of performance criteria and test procedures

• Selection of critical parameters, with predefined specifications

• Determination of test intervals, e.g.

- Everyday

- Every time the system is used

- Before, between, and after a series of runs

• Definition of corrective actions to be taken if the system does

not meet the established criteria

Component Qualification

Component qualification (CQ) is a relatively new term developed

in 2005. This term refers to the manufacturing of auxiliary

components to the correct design criteria. This could include

packaging components such as folding cartons, shipping cases,

labels, or even phase change material. All of these components

must have some type of random inspection to ensure that the

third party manufacturer’s process is consistently producing

components that meet requirements.

Why Pyramid?

At Pyramid, we train our staff on the latest FDA regulations and

implementation of all the technical controls required for 21 CFR

Part 11 compliance. Our Computer System Validation (CSV) team

also has in-depth experience in Software Engineering, Software

Development Life Cycle (SDLC), and Validation.

In addition to our experienced staff and proven

methodology, Pyramid’s strengths include:

• Established Regulatory Knowledge for achieving

Part 11 compliance

• Extensive experience in applying GAMP Methodology across

the life cycle for computer systems validation

• Expertise including pharmaceutical and biologics manufacturers,

medical device manufacturers, clinical research organizations,

and GLP laboratories

• Jump start kits to maximize customer return on investment

• Implementation efficiencies achieved by streamlining the

flow of tasks and responsibilities defined for each stage

• Computer system validation experts with deep experience in all

types of FDA-regulated businesses, including pharmaceutical

and biologics manufacturers, medical device manufacturers,

clinical research organizations, and GLP laboratories

• Extensive documentation and process improvement

reports and templates

• Competitive costs via offshore-leveraged, catalog-driven,

transaction based pricing model

• End-to-end testing: enterprise apps, data migration testing,

performance testing, functional testing, penetration testing,

accessibility testing, and compatibility testing





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WE TRAIN OUR STAFF ON THE LATEST FDA REGULATIONS AND IMPLEMENTATION OF ALL THE TECHNICAL CONTROLS REQUIRED FOR 21 CFR PART 11 COMPLIANCE

Pyramid Consulting Inc. - World Headquarters

11100 Atlantis Place, Alpharetta, GA 30022

Phone: 678.514.3500, Toll Free: 877.248.0024

[email protected]

Documents

FDA Validation Testing · The FDA requires that medical device manufacturers, pharmaceuticals manufacturers, biotech companies, biologic developers, and other FDA-regulated industries