Apr 30, 2021
By Sarah Czarnowski

How to Address Common Challenges When Outsourcing GMP Asset Maintenance and Calibration

Pharmaceutical companies are required to meet current good manufacturing practice (cGMP) regulations that ensure their products are safe, pure, and effective. cGMP regulations provide guardrails that help companies produce consistent end products (including clinical material) and minimize instances of contamination, mix-ups, and errors.

While these regulations are meant to protect consumers from purchasing ineffective or dangerous products, they also help keep manufacturing plants up and running by ensuring equipment is maintained and staff is trained appropriately.

Despite these regulations and efforts, the pharmaceutical industry continues to be plagued by drug shortages, which are often caused by quality and manufacturing issues. Now, as the industry focuses on the production of COVID-19 vaccines, it is more important than ever that manufacturers meet cGMP regulations to ensure their equipment is perfectly maintained.

Maintenance procedures involve both preventive and corrective actions, including fine-tuning and calibrating sophisticated pharmaceutical manufacturing equipment. Because the production of tablets, ampoules, and syringes is highly automated, manufacturers need to ensure they properly maintain and calibrate their equipment. If they don’t, they risk not having a continuous supply of high-quality medicines.

Common Challenges with Outsourcing Equipment Maintenance and Calibration

Some organizations perform in-house maintenance and calibration, some completely outsource all work to third parties, and others choose a combination of both.

When outsourcing work, you must coordinate projects across internal and external teams. Plus, you need to maintain full visibility and detailed reporting at every step in the process for accountability, budget tracking, and service key performance indicators. But this is rarely simple.

In many cases, maintenance work is performed by one vendor, while calibration is carried out by another vendor. This can result in:

  • Inconsistent reporting: When data is separated between multiple vendors and your organization’s internal systems, it becomes harder for you and your team to make strategic decisions.
  • Technological disconnects: Third-party maintenance providers often use their own tools that not only require additional license fees, but also may not easily connect to your organization’s on-premises systems. This requires vendors to monitor and update multiple systems manually.
  • Work delays: Teams often maintain equipment inventories across multiple databases, which can lead to overhead and additional time to initiate, perform, track, and complete maintenance work.
  • Avoidable mistakes: Maintaining separate workflows and checks and balances is manually intensive and prone to errors or mistakes. Schedules run by hand can even be forgotten, leaving some equipment unmaintained.
  • Limited scalability: While many outsourced services rely on mobile capabilities to create, perform, and track work orders, they may require expensive, custom handheld devices that limit remote teams.

Manage Your Equipment, Maintenance, and Calibration Activities from One Platform

Nuvolo Connected Workplace for Life Sciences addresses these challenges head-on and helps you meet cGMP and enhance your workflows. With Nuvolo, you can manage all assets and the maintenance and calibration activities in your manufacturing facilities on one cloud-based Connected Workplace platform that’s shared across vendors and departments. This allows you to:

  • Connect maintenance and calibration data across all vendors, helping your team track and report on work and equipment service history.
  • Provide an easy-to-use platform for third-party vendors and employees to send service requests, creating a seamless user experience.
  • Ensure accurate asset inventory, automate your work order management, and auto-assign preventative maintenance, streamlining workflows.
  • Create checklists for equipment inspections, manage vendors, and track equipment warranties to keep your facilities and equipment running smoothly.
  • Leverage a mobile application to perform work at the point of service with the mobile devices and tablets you already use.
  • Bring all asset maintenance data into in a single system, allowing for comprehensive cost analysis and optimization while ensuring equipment is maintained and available for production runs.

Our Maintenance solution also includes calibration capabilities such as automatic calculations. The platform calculates error and PASS/ADJUST/FAIL statuses in real time during calibration, minimizing a never-ending cycle of re-calibrations. In addition, because you can synchronize and access calibration data on any device, multiple vendors can work from the same source of truth and close communication gaps. If a problem is found during a calibration inspection, real-time work order scheduling kicks in to resolve the issue.

By implementing Maintenance, customers have realized:

Nuvolo helps reduce the number of past-due critical work orders, decreases time spent onboarding vendors and managing work orders, and more – resulting in significant yearly savings.

 

As an integrated workplace management system (IWMS) built on NOW™, Nuvolo Connected Workplace for Life Sciences brings all functionality spanning maintenance, enterprise asset management, field service management, space, real estate, projects, and sustainability into one easy-to-use platform.

With Nuvolo, you can finally achieve a seamless digital transformation.

 

Learn more about our Maintenance solution.

Learn about Nuvolo Connected Workplace for Life Sciences.

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