Jun 02, 2021
By Sarah Czarnowski

Streamline GMP Maintenance and Compliance with the Connected Workplace

Quality and compliance are at the center of all life sciences companies’ operations—and for a good reason. Regulations ensure companies produce safe, consistent products, while minimizing contamination, mix-ups, and errors. Non-compliance has serious consequences, ranging from expensive fines and damaged company reputations to dangerous or ineffective products reaching the market and potentially harming patients.

As one of the most heavily regulated industries, life sciences companies must follow current good manufacturing practices (cGMP) that are defined under Title 21 CFR. cGMP covers all elements of the production process, including which raw materials are used, the condition of the physical space, the condition and maintenance of equipment used, the steps taken by staff during manufacturing, and staff training. Meeting cGMP standards can be arduous given that many teams, pieces of equipment, and utilities are involved in production. Plus, data on these people, places, and processes are frequently kept in separate, sometimes paper-based, systems.

Streamlining Regulatory Compliance

There is now an easy way to maintain accurate records and ensure data integrity: Nuvolo Connected Workplace for Life Sciences. Our platform manages complete asset lifecycles and maintenance, resulting in fewer disruptions and providing a central source of truth to inform business decisions.

With robust audit trails, versioning history, and CFR Part 11 and Annex 11 compliance, all asset management and service history—including change requests—are recorded in one place. This helps speed up batch record certification and improves production, process controls, documentation, and work order management. Because not all equipment is regulated, you are able to assign workflows dynamically based on whether equipment is tagged as GMP or non-GMP. Additionally, you have access to key workflows for:

  • FDA support and mapping
  • GMP compliance tracking
  • Calibration
  • Skills and competency tracking
  • Product recall and safety alert management
  • Standard or custom risk inclusion frameworks
  • Preventive and corrective maintenance assignments

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

How We Got Here

Nuvolo has brought on life sciences experts to expand our deep roots in healthcare, compliance, and quality to meet the needs of the industry. We have conducted market research, collaborated with life sciences companies, and successfully passed customer compliance audits, ensuring our product meets your business needs as well as industry regulations.

The culmination of these investments is a robust compliance program that meets or exceeds all regulations. We hold and maintain an 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). Our SDLC processes align with our computer software assurance (CSA) program, allowing our teams to leverage testing responsibilities. Nuvolo has partnered with a third-party software validation provider to conduct CSA testing as an additional quality oversight of our compliance pack. The pack includes functional requirement specifications (FRS), a GxP impact assessment, installation qualification (IQ), operational qualification (OQ), a traceability matrix, and a validation summary report.

On average, a customer can save over 600 hours when they install and use our compliance pack, which helps you accelerate your organization’s internal validation of Nuvolo Connected Workplace, including user acceptance testing. Lastly, Nuvolo must pass a rigorous inspection process to release application updates to the ServiceNow app store. As part of the app store certification, our products are tested 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.

By working with Nuvolo, you can streamline your business processes without compromising quality. See how Vertex Pharmaceuticals moved away from traditional EAM and IWMS systems and chose us as their Connected Workplace for Life Sciences partner. Interested in learning how you can streamline your processes and be audit-ready? Contact us.