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Software Validation Services
Software Validation Services for 21 CFR/Part 11 Compliance
Is your lab required to comply with a regulatory body of standards, such as 21 CFR Part 11 regulations? 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.
You have access to a comprehensive Compliance Services portfolio offered by AB SCIEX. The services include Software Validation Services
for Analyst®, MultiQuant™, and Analyst Administrator Console (AAC). AB SCIEX provides a complete validation solution for the regulated
laboratory environment including MS IQOQ, LC IQOQ* and LC/MS PQ.
Software Validation Services provides a full IQ/OQ/PQ of the software packages using a set of standard requirements for use in a
regulated setting, including security and audit trail configuration and testing.
Analyst Software Validation includes configuration and testing of the following (requirements met**):
•
Security (10)
•
Analyst Software roles and responsibilities (30)
•
System installation (1)
•
Data integrity (10)
•
System configuration (3)
•
Req’s for all audit trail events (11)
•
Project audit events (14)
•
Quantitation audit events (21)
•
Project management (4)
•
Instrument audit events (4)
•
Batch file setup (12)
•
Compound/instrument optimize/manual tuning (8)
•
Sample queue (17)
•
Acquisition/acquisition methods (4)
•
Quantitation (31)
•
Explore mode/qualitative analysis (4)
•
Reporting (33)
•
Quantitation algorithms (3)
On-Site Validation provides you with standard software validation performed by AB SCIEX certified representatives. The service provides
on-site testing and validation of typical system requirements for regulatory compliance. This includes full configuration and testing of
security settings, audit trails, and other regulatory relevant features.
Software Validation Documents include:
•
Validation plan
•
IQ/OQ/PQ test cases and objective evidence
•
Risk assessment
•
Traceability matrix
•
User and functional requirements Specification (UFRS)
•
Part 11 compliance assessment
•
System design and configuration specification
•
Validation summary report
•
Validation test plan
•
Vendor audit report
Benefits to you:
Guarantee
You are guaranteed that after AB SCIEX completes your validation
•
Unique knowledge and experience
•
Cost control
•
Use of current regulatory best practices
compliant, AB SCIEX will address the issue and re-validate if
•
Reduced validation time
necessary, at no cost to the customer.
•
Project management expertise
your software will pass an audit. If a regulator, auditor, or other
compliance office finds the validation of the software to be non-
For more information on compliance services or to request a quote
please contact your AB SCIEX Sales or Service representative,
What do you get?
email [email protected]
After completing a Pre-scoping worksheet that details your
systems and environment, a set of documents that is specific to
your lab is generated for your approval. Once those documents
have been approved, members of the AB SCIEX Compliance
* LC IQOQ not available for all configurations
Services team will come on-site to perform the validation. The
**At time of writing
“first-in-family” instrument usually takes 4-5 days to complete
the validation, 1-2 days for each additional instrument.
Assay/Instrument specific
Commitment to quality
System Suitability
Our Compliance Services team follows best practices set by Project
Management Institute®’s (PMI) Project Management Body of
Method Validation
Knowledge (PMBOK). PMI has long been acknowledged as a pioneer
in the project management field and has a membership representing
a global community of over 100,000 professionals from 125
GLP Lab
AB SCIEX LC/MS PQ
countries.
Our commitment to this global standard of excellence means that
you not only get our industry expertise and technical knowledge, but
the highest level of quality in project management. To further ensure
Software Validation
HPLC OQ
MS OQ
HPLC IQ
MS IQ
superior service, our professional services organization adheres to
the principles set by our global project management office, which
provides full project control and management support.
Following these best practices helps to ensure that we meet your
timelines within prescribed standards, manage project constraints
Performed by Customer
Offered by AB SCIEX
and budget, minimize costs, and maximize quality.
For Research Use Only. Not for use in diagnostic procedures.
© 2014 AB SCIEX. The trademarks mentioned herein are the property of AB Sciex Pte. Ltd. or their respective owners. AB SCIEX™ is being used under license.
GEN-MKT-07-1812-A 11/2014
Non-GLP Lab
(Optional)