7 Ways to Leverage SaaS Systems in a GxP Regulated Environment

As a scientist working in an environment adhering to GxP regulations, you know the challenges that come with research and development (R&D). You must evaluate each step toward innovation in terms of compliance with GxP regulations. Managing GxP variables such as data integrity, documentation, and audit readiness can often hinder the momentum of your research.

However, you can eliminate this friction by implementing a SaaS (Software as a Service) solution with a proven track record of integrating directly into your GxP environment. Revvity Signals Software has one such solution.

The GxP Equation

The first step when discussing SaaS is to recognize the importance of complying with GxP regulations in the R&D process. GxP refers to quality and regulatory guidelines that protect product integrity, safety, and effectiveness. These regulations ensure that the R&D process meets the highest standards of reliability, safety, ethics, quality assurance, data integrity, patient safety, regulatory compliance, risk management, and global market access.

SaaS as a Strategy

Introducing SaaS practices into your organizational workflow can help balance innovation and regulatory requirements. A SaaS platform is a strategic tool that can ultimately streamline your operations, facilitate growth, and improve efficiency.

SaaS applications provide your teams with real-time collaboration, automated compliance, enhanced data security, and cost-effectiveness. The subscription-based model eliminates your need for upfront investments in software and infrastructure, making it a highly cost-effective solution. Moreover, the SaaS model covers regular updates and maintenance, making it easy to adapt to changing regulations without needing more IT resources.

GxP SaaS Allows for Simplified Validation

SaaS applications are highly advantageous for scientists working in regulated environments. The validation process for SaaS applications is highly predictable and usually requires fewer resources and less time compared to non-SaaS applications.

SaaS vendors simplify the validation process for R&D organizations by handling a significant portion of the validation work. This includes conducting baseline testing and providing corresponding documentation, eliminating your need to repeat these steps. Moreover, since SaaS applications receive more frequent updates, it reduces the testing workload, making it easier to maintain validation while efficiently planning resources.

SaaS suppliers can also prove the soundness and compliance of their Software Development Life Cycle (SDLC) and Quality Management System (QMS). Another benefit of a SaaS to your organization is a solid infrastructure for data security and threat detection.

7 Ways to Leverage SaaS in a GxP Industry

One SaaS solution that is purpose-built for the specific challenges within GxP-regulated environments is Revvity Signals Notebook. It delivers a range of features designed to enhance compliance and operational efficiency while supporting R&D innovation. Signals Notebook SaaS application provides:

  • Automated Compliance Workflows: Signals Notebook streamlines compliance processes by providing automated workflows. This includes documentation management, audit trails, and other essential tasks, ensuring that GxP regulations are seamlessly integrated into the daily operations of R&D teams.
  • Data Integrity Assurance: Prioritize data integrity by implementing robust security measures, encryption protocols, and access controls. This ensures that research data is secure and maintains its accuracy and reliability, a critical factor in GxP compliance.
  • Real-time Collaboration Tools: Team collaboration is central to successful R&D. Signals Notebook provides real-time collaboration tools that enable seamless communication and collaboration among teams located in labs worldwide, enhancing the efficiency and effectiveness of research initiatives.
  • Audit Readiness: This SaaS application generates comprehensive audit trails and documentation, making it easier for R&D teams to demonstrate compliance during regulatory audits, saving time and resources.
  • Scalability and Flexibility: As R&D evolves, the platform adapts to changing project requirements and accommodates the growth of research initiatives without disrupting operations.
  • User-friendly Interface: A user-friendly interface ensures that R&D scientists can easily navigate and utilize the features. This promotes widespread adoption within the organization, contributing to a smoother transition towards a more efficient and compliant R&D process.
  • Regulatory Updates and Adaptability: Revvity Signals stays abreast of regulatory changes and swiftly incorporates updates to comply with evolving GxP regulations. This adaptability ensures that your R&D processes remain aligned with the latest compliance standards, providing a proactive approach to regulatory changes.

In addition, Revvity Signals:

  • Provides a deep Validation Documentation package including: IQ, Validation Certification with results from OQ and verification testing, and Release Notes.
  • Has SOC2 Type 2 attestation.
  • Is ISO 9001 and ISO 27001 compliant.
  • Provides an experienced professional services team to implement, monitor, and support customers in adopting Signals Notebook.

Signals Notebook

Revvity Signals flagship SaaS solution for adhering to GxP is Signals Notebook. Signals Notebook Enhanced Enterprise Edition (E3) and Signals Notebook Private Cloud are validation-ready and can be considered fully validated upon your completion of the documentation and validation activities. Signals Notebook supports a comprehensive set of scientific use cases with dedicated functionality for GxP regulated work. In addition, Signals Notebook facilitates robust data capture procedures and workflows which improve reliability, compliance, and data reuse.

Signals Notebook is 21CFR part 11 compliant-ready and provides:

  • Audit trails
  • Sign/close/witness workflows
  • The ability to lock down templates
  • The ability to capture reasons for change
  • Archiving experiments capabilities
  • Authentication security through use of your own IdP

As organizations strive for excellence in GxP compliance and R&D innovation, SaaS, specifically Revvity Signals Notebook, emerges as a valuable partner, paving the way for a future where every step forward is both compliant and fueled by an unstoppable spirit of discovery.

With SaaS, your scientists receive new functionality regularly versus any on-premise software. Your IT team experiences a simplified validation process and a more regular update cadence with less testing and documentation requirements – a win-win for your entire organization.

Ready to get started with Signals Notebook Enhanced Enterprise Edition (E3) or Signals Notebook Private Cloud?
Visit our Revvity Signals products page, sign up for a free trial, or schedule a demo with our team to elevate your R&D efficiency!

Diana Tran
Sr. Product Marketing Specialist for Signals Notebook

Diana Tran leverages over 10 years of healthcare and biotech experience in her role as Senior Product Marketing Specialist for Signals Notebook at Revvity Signals Software, Inc. She joined Revvity Signals over 4 years ago and is responsible for go-to-market strategy, positioning, and messaging for Signals Notebook.

Ms. Tran earned her Bachelor of Science in Pharmaceutical and Health Science from MCPHS University in 2013. Since then, she has worked across various roles that have allowed her to develop specialized expertise at the intersection of science, technology, and marketing.