fda validation testing · the fda requires that medical device manufacturers, pharmaceuticals...
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FDA Validation Testing
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QA CENTER OFEXCELLENCE SOA SERVICESFDA VALIDATIONFUNCTIONAL
PERFORMANCE AGILEBIG DATASECURITY
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QA CENTER OFEXCELLENCE SOA SERVICESFDA VALIDATIONFUNCTIONAL
PERFORMANCE AGILEBIG DATASECURITY
AUTOMATION LEGACYCLOUDMOBILE
FUNCTIONAL
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FDA Validation Testing
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
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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
FDA Validation Testing
QA CENTER OFEXCELLENCE SOA SERVICESFDA VALIDATIONFUNCTIONAL
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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
FDA Validation Testing
QA CENTER OFEXCELLENCE SOA SERVICESFDA VALIDATIONFUNCTIONAL
PERFORMANCE AGILEBIG DATASECURITY
AUTOMATION LEGACYCLOUDMOBILE
FUNCTIONAL
QA CENTER OFEXCELLENCE SOA SERVICESFDA VALIDATIONFUNCTIONAL
PERFORMANCE AGILEBIG DATASECURITY
AUTOMATION LEGACYCLOUDMOBILE
FUNCTIONAL
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