Sep 02, 2021
By Sarah Czarnowski
Solution Overview

Compliance in Nuvolo Connected Workplace

Helping regulated companies achieve and maintain compliance is at the center of Nuvolo’s commitment to provide Life Sciences organizations with reliable features that support controlled asset management.

Behind the Scenes: A Robust Compliance Program

We have conducted market research, collaborated with life sciences companies, and successfully completed customer compliance audits, ensuring our product exceeds your business needs as well as industry regulations. Benefits of our software include:

  • ISO 9001 certification, which provides oversight and management of our software development lifecycle (SDLC) and compliance pack (also known as a validation pack throughout the industry)
  • An SDLC process that aligns with our computer software assurance (CSA) program, allowing our teams to leverage testing responsibilities
  • A partnership with a third-party software validation provider to conduct CSA testing as an additional quality oversight of our compliance pack
  • A rigorous inspection which tests our product against over 70 requirements that ensure security and performance of the application, completeness of the marketing and listing information, and platform stability and user experience

The compliance deliverables package includes:

  • Functional requirement specifications (FRS)
  • GxP impact assessment
  • Installation Qualification (IQ)
  • Operational Qualification (OQ)
  • Performance Qualification (PQ) for SMB customers*
  • Traceability Matrix (TM)
  • Validation Summary Report (VSR)

By working with Nuvolo, you can streamline your business processes without compromising quality.

User Experience

As a user, you can easily maintain accurate records and ensure data integrity. Nuvolo Connected Workplace is built with compliance controls and provides:

  • A controlled versioning process to ensure that defined maintenance activities are subject to a review process before production use
  • Flexible enforcement of versioning controls based on GxP relevance and risk factors
  • Configurable workflows that allow groups or individuals to be aligned to the desired approval process
  • Exportable audit trails that are permanently associated with your controlled records, plus electronic signatures that meet 21 CFR Part 11 requirements
  • Automated preventive and corrective maintenance assignments
  • Technician skills and competency tracking
  • Product recall and safety alert management support
  • Standard or custom risk inclusion frameworks

By keeping all information and procedures in one place with a consistent and modern user experience—and on a shared platform accessible by many teams—it is much easier to promote accountability and maintain compliance.

*PQ will be available Q1 2022.