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SOFTWARE COMPLIANCE SERVICES
Software Compliance Services
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SCALABLE, EXPERT SOFTWARE COMPLIANCE SERVICES TO MEET YOUR NEEDS
Scalable, expert software compliance services to meet your needs
Lab managers know that maintaining control of a computerized laboratory system
from installation on is a time-consuming activity, and software validation
activities can have a significant impact on overall lab productivity and be an
added burden on your team.
Waters validation and compliance experts can accelerate the deployment of your
new instrument software systems. Our dedicated team will demonstrate that your
workstation, workgroup, or enterprise solution is fit for intended use and
aligns with regulatory requirements.
Software Compliance Services
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OVERVIEW
* Cost-effectively accelerate the installation, configuration, and testing of
Waters software applications
* Ensure user acceptance testing complies with current GxP regulations
* Streamline the entire compliance process— from critical planning to
validation reporting
* Establish processes with documentation that supports ongoing product
production in accordance with predetermined specifications and quality
attributes
* Manage software upgrades and planned system changes to ensure the compliant
state of instrumentation
Recommended Use: For the compliant deployment and ongoing use of your instrument
software system.
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FEATURES HEADER
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ADDRESS YOUR COMPLIANCE CHALLENGES HEAD-ON WHILE REDUCING RISK
Our services align with international GxP regulations including, but not limited
to: the United States Food and Drug Administration (USFDA) Code of Federal
Regulations (CFR) Title 21 Part 11, 58, 210, 211, 820, the Pharmaceutical
Inspection Co-operation Scheme (PIC/S) computerized system guidance, EudraLex
Volume 4, Annex 11, World Health Organization (WHO) TRS 986 Annex 2. In
addition, documentation follows Good Documentation Practices (GDocP) and current
industry-recognized standards and methodology with the International Society of
Pharmaceutical Engineering (ISPE) Good Automated Manufacturing Practice (GAMP®)
5.
Waters can assist you with all phases of your validation planning:
* Initiation of approach through risk assessment
* Scope definition with associated tasks and prerequisites
* Requirements and configuration specification
* Test plan creation and requirements test development
* Traceability matrix alignment
* Project report summary
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MAINTAIN SOFTWARE COMPLIANCE FOR THE LIFETIME OF YOUR WATERS INVESTMENT
A thorough approach requires the protection and maintenance of the software
system's validated state throughout its operational lifecycle. All Waters
software can be deployed with routine Installation Qualification (IQ) and
Operational Qualification (OQ) services.
Waters Validation Consultants help you support existing quality processes with
Compliance Services for routine use of Waters Data Systems Solutions, which
include:
* Risk-based requirements testing
* System use and administrative standard operating procedures (SOPs)
* Electronic data and audit trail review process
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RESOURCES
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BROCHURES
* Tobacco Analysis Solutions for Regulatory Compliance and Research
* Validation Consulting Services
* Compliance and Validation Services for Waters Informatics Solutions
* Professional Services Brochure
* Empower 3 Software Deployment Services
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INFOGRAPHICS
* Professional Services For Data Integrity Infographic
WHITE PAPERS
* Waters' Scalability Strategy - Moving Beyond the Traditional Approach
* Practical Considerations for Laboratory Software Scalability
* Real Application Clusters - Scaling Up and Out for Seamless Growth
* Executive Summary | Data Integrity for your Laboratory Computerized Systems
* Empower 3 Software Audit Trails and Logs: A guide to the different locations
of audit trails in Empower and what information they provide to reviewers
* Executive Summary | Why is Electronic CDS Data a Major Data Integrity Concern
for Regulators?
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Professional Services
Once your system has been installed and configured, Waters can assist you with
your Computer System Validation (CSV) needs and provide consultation to maintain
compliance and alignment with regulatory expectations.
Instrument Qualification Services
High quality compliance tools and services that provide a comprehensive approach
you can deploy globally, ensuring the integrity, accuracy, and authenticity of
your laboratory results for your UPLC, UHPLC, HPLC, GC, GC-MS, and LC-MS
Systems.
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