Software Compliance Services
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
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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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
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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