Software Compliance Services

Software Compliance Services

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.

Reduce the risk of obsolete software with your software maintenance plans. 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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Related

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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Laboratories must comply with strict industry regulations to ensure data accuracy, security, and efficiency. Laboratory Software Compliance Services and LIMS (Laboratory Information Management System) Software Validation help labs meet regulatory standards set by authorities like FDA (21 CFR Part 11), ISO 17025, GxP, MHRA, and HIPAA. These services ensure software systems function correctly while maintaining audit readiness and data integrity.

Laboratory Software Compliance Services involve assessing, implementing, and validating laboratory software, including LIMS, Chromatography Data Systems (CDS), and Electronic Laboratory Notebooks (ELN). These services help identify risks, prevent compliance issues, and ensure proper system setup. Key aspects include regulatory assessments, system validation, audit preparation, data security, and regular compliance checks. By using these services, laboratories can improve efficiency, minimize risks, and stay compliant with evolving regulations.

LIMS Software Validation ensures that a Laboratory Information Management System operates correctly and meets regulatory requirements. The validation process follows structured steps, starting with User Requirement Specifications (URS) to define the lab's needs. Next, a risk assessment and gap analysis identify any compliance issues. Validation includes Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) to confirm the software is installed correctly, functions as expected and performs reliably in real-world conditions. Maintaining detailed documentation and managing software updates is also essential for long-term compliance.

These compliance and validation services are crucial for laboratories to maintain accuracy, data integrity, and regulatory adherence. Non-compliance can lead to penalties, operational disruptions, and security risks. Proper validation not only ensures legal compliance but also enhances productivity by optimizing software performance. It enables audit readiness, data security, and workflow efficiency, allowing labs to operate smoothly.

By integrating Laboratory Software Compliance Services and LIMS Validation, laboratories can stay ahead of regulatory changes and maintain reliable, compliant systems. These services provide a structured approach to compliance, helping labs focus on delivering high-quality, accurate results while meeting industry standards.