Recent upheaval in the workplace as a result of the pandemic has left many regulated labs with a backlog of maintenance and operational qualifications (OQs) to address. Add to this stress the likelihood that there are reduced on-site staff to support the workload, and you're looking for ways to improve productivity and efficiency wherever possible. Now may be a good time to reassess and improve your compliance protocols.
Digital capabilities improve qualification services
Many pharma labs today are still running paper protocols, which generally take longer to perform, require more personal interaction, and introduce the potential for more errors than electronic protocols. Agilent's automated compliance engine (ACE) is automated and electronic, enabling qualifications to be performed more quickly, and to be completely paperless.
"ACE is a digital solution that streamlines the process, giving you a significant efficiency advantage," says Paul Smith, a compliance expert with Agilent CrossLab. "The Agilent CrossLab team can typically perform a preventive maintenance and OQ in less than one day on most systems using ACE."
In today's resource-stressed environment, the advantages of ACE go much further. Reviewing and approving compliance documentation electronically is not only more efficient; it also enables the lab to store those documents electronically and ensure proper tracking and security.
Harmonization drives speed and efficiency
Harmonizing instrument OQ protocols across your lab increases efficiency and analytical integrity – it's faster and easier to approve documents, because they all look the same, whether they are for an Agilent or a non-Agilent instrument. "If you have six or eight suppliers coming in with different documentation, it's more time-consuming to manage and review," says Paul Smith. "When you add in the complexity of new people who may be taking on different responsibilities, harmonization of protocols and consistent documentation become really important to your compliance program."
ACE currently supports all Agilent hardware products and a broad scope of non-Agilent laboratory instrumentation, including Waters, Thermo, Bruker, AB Sciex, and more.
Expanding access of support: Software validation
As on-site resources are stretched, more labs have leveraged Agilent CrossLab experts to support their computer system validation work. Working with Agilent CrossLab to design your computer system validation will usually reduce the total validation time by 50%. Most of the upfront work – requirements gathering, protocol development, reviews, and approvals – gets done remotely; ultimately, the test script execution gets done on site.
Remote software deployment and qualification: The big payoff
One of the significant advantages of having a networked lab – a lab that has a client/server chromatography data system (CDS) – is the ability to work remotely and deploy the system remotely. Moving to an OpenLab CDS lets you take advantage of these opportunities.
For labs operating with OpenLab, Agilent CrossLab engineers have been able to perform remote installation of software and the corresponding software qualification.
"This is being done extensively in the US and Europe, and it can be done anywhere in the world, provided there is a reliable internet connection," says John Catlin, senior director, Agilent Lab Informatics Services and Support. "We are not only able to support remotely, but we can also expand a lab's system remotely, upgrade, and deploy. Almost everything we do, we have remote solutions to offer where we don't have to be on site."
Importantly, remote support saves labs money. "Customers who were once very resistant to having remote services are now recognizing the great benefits of remote access," says John.
"Today, remote deployment is standard where on-site deployment has an upcharge. Remote deployment and support can save customers significantly because they don't have to pay for travel and the time involved. This allows customers to spend the money they save on higher-value items or services for their lab."
Get in touch with an Agilent CrossLab compliance expert – visit https://www.agilent.com/en/service/laboratory-services/compliance-services for more info.
For more information about setting up a client/server system for your chromatography data system, visit https://www.agilent.com/en/products/software-informatics/openlab-software-suite