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INTEGRATED COMPLIANCE SERVICES
Are your systems
compliant?
INTEGRATED COMPLIANCE SERVICES
Meet the
validation challenge
Assure your
instrument and
software are up to
the task.
In regulated industries, compliance with government and international standards, such
as GxP and 21 CFR Part 11, requires documented verification that your instruments are
installed and functioning within their operational specifications. The process can be
complex, time-consuming, and costly.
Additionally, computerized systems that generate electronic records must be properly
secured to prevent unauthorized access, ensure security of data, and prevent data
corruption, loss, or falsification. This is required by global standards (e.g. GLP, GCP, GMP)
as well as other regulations.
How to achieve compliance?
Compliance can be achieved by conducting hardware qualification and software validation.
IS MY SYSTEM DOING
THE JOB RIGHT?
IS MY SYSTEM DOING
THE RIGHT JOB?
Analytical instrument qualification
Computer system validation
Non-method specific test(s) based upon
System test based upon laboratory requirements
accepted parameters such as:
such as:
•
Precision
•
Security settings
•
Detection linearity
•
Audit trails
•
Accuracy
•
User configuration
•
Gradient operation
•
System configuration
What do GLP/regulated labs need to do?
Benefit of software validation
•
Assess you risks
Assure all parties (QA/QC, auditors, regulators, customers) that your system is
•
Identify controls to put in place
operating as intended and that you demonstrated that studies conducted on your
•
Put controls in place
•
Monitor controls for effectiveness
regulated systems are accurate and the data is secure because you conducted
software validation that accomplish the following:
•
Understand your requirements
•
Test them thoroughly
•
Collect objective evidence to prove it!
Who is responsible for software validation?
While you can use third parties to design and perform the software validation, the
Are you using a non-integrated compliance strategy? Do you have a fully-validated,
responsibility for software validation and the maintenance of a validated system
GLP-ready system? But, what do you really have? You have a set of documents,
cannot be delegated.
prepared by different vendors, written in different formats and styles and using
non-specific requirements. You’re inconvenienced by multiple vendors coming into
AB SCIEX Compliance and Validation Services offers integrated compliance process to
the lab and creating increased instrument down-time.
pharmaceutical companies, CRO’s, and other labs across the globe.
• You
receive expert advice from PMI-certified Validation Consultants and outside
experts, acting as an additional set of eyes and ears to evaluate and optimize your
laboratory operations, in a compliant fashion.
• Based
on your requirements, your Validation Consultant will assist you on-site or
remotely to achieve GLP/FDA/EMEA/GMP compliance standards.
Once you have your documents you may find it difficult trying to explain your
compliance strategy based on test plans used by multiple vendors for your system
to QA or an auditor, assuming you can locate the specific tests, results, and objective
evidence required. Since your system components have not been tested as they
are operated in your lab the data may not be an accurate representation to
regulatory authorities.
There is a better way...
AB SCIEX integrated compliance process
Using a single vendor to perform your end-to-end compliance package has
obvious advantages:
• Integrated
• All
PQ tests the system after LC IQOQ, MS IQOQ, and SW Validation to
ensure the components perform to specification as an integrated system
test plan and validation plan
• The
ability to leverage tests across compliance activities lowers costs and
execution time, resulting in a system and instrument that is up and running
documents are harmonized for style, content, and purpose
• Your
• L
CMS
and qualified/validated in just a few days!
system functions as one integrated system in your lab, it should be treated
as such for compliance purposes
Integrated Compliance Process
VALIDATION
PLAN
Validated People (Training)
HPLC IQOQ
TEST PLAN
Data Management
Validated Processes/ Workflows
MS IQOQ
Disaster Recovery/Back-up
LCMS PQ
Validated Methods
SW Validation
Data/System Security
Which compliance services do you need and when?
For GLP/regulated labs /pharma/labs needing confirmation of system operation/performance
New purchase/new installation
Re-install/move
•
M
S IQOQ (Installation Qualification/Operational Qualification)
•
MS IQOQ (Installation Qualification/Operational Qualification)
•
LC IQOQ (Installation Qualification/Operational Qualification)
•
LC IQOQ (Installation Qualification/Operational Qualification)
•
L CMS PQ (Performance Qualification – some customers use this a
•
LCMS PQ (Performance Qualification)
System Suitability Test/SST )
•
SW version upgrade – ie Windows, Analyst, etc
SW Validation (for Analyst®, AAC, MQ)
•
SW Validation/SW Change Control Validation
System currently in use – done as per SOP’s/regulations/annually
•
MS OQ (Re-Qualification)
•
LC OQ (Re-Qualification)
•
LCMS PQ (Performance Qualification / SST)
End-to-End System Validation Process
EVALUATION
AND TESTING
•
re-scooping
P
worksheet
•
Validation plan
•
Vendor assessment
•
alidation risk
V
assessment
SYSTEM DESIGN
•
•
User and functional
requirements
specifications
S ystem design
and configuration
specifications
TEST PLANNING
TESTING
•
Test plan
•
LC IQ OQ
•
Traceability matrix
•
MS IQ OQ
•
S oftware validation
IQ OQ PQ
•
Discrepancy resolution
•
LC MS PQ
•
T est execution.
Reviewed/approved.
POST EXECUTION
ACTIVITIES
•
V
alidation summary
report
•
F inal document review
PROJECT
COMPLETION
•
Change
management
•
R
etirement planning
•
D
eployment
•
M
aintain validated
state
Benefits
Computer system validation philosophy and testing
•
System tests based upon laboratory
requirements such as:
Utilizes a GAMP5 framework
Simplicity – A single point of contact that
works with you to manage the testing and
•
Security settings
•
Audit trails
– Full testing on 1 instrument
•
User/system configuration
Flexibility – Validation documents are
– Replicate testing on additional instruments
•
Change control
modified as necessary for laboratory-specified
– Based upon what is configurable and what can impact
•
User training
•
Engagements use a 1st in Family/ Replicate model
regulatory compliance
•
validation process
requirements
Speed – You receive SW validation knowledge
and expertise to validate your instrument
Recommend single version of SW across the analytical lab
– SOP enforced
Cost control – Don’t re-invent the wheel –
use field-tested AB SCIEX SW validation packages
Peace-of-mind – Trained and PMI certified
project managers with years of software
validation experience and extensive global
regulatory understanding assess and help
SW Validation Relationships
minimize compliance risk
USER REQUIREMENTS
RISK ASSESSMENT
TEST PLAN
VALIDATION PLAN
Ready for integrated
compliance solutions?
Contact your local AB SCIEX sales representative
or email [email protected]
TRACEABILITY MATRIX
TEST CASES
Your success is our success
We take it personally
As an AB SCIEX customer you have access to a world-class customer support organization.
Wherever you are, we’re there with you as a trusted partner to answer questions, provide
solutions, and maximize lab productivity.
Our customer support organization has access to the latest product updates, software
revisions, methods and repair procedures to make sure that you stay on top of your game.
When you have questions, we have answers.
For Research Use Only. Not for use in diagnostic procedures.
Learn more at www.absciex.com/customersupport, or locate your local account
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AB Sciex Pte. Ltd. or their respective owners. AB SCIEX™ is being used
under license.
GEN-MKT-07-1813-A 1/2015
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