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Quality Digest


New Validation Pack From Qualio

Faster, more user-friendly for life sciences

Published: Thursday, November 3, 2022 - 11:01

(Qualio: San Francisco) -- Qualio, a trusted cloud quality management system software for the entire life sciences ecosystem, announced its Validation Pack to help quality professionals in the life sciences sector take a faster, less resource-intensive approach to the latest Good Automated Manufacturing Practice (GAMP) and computerized system assurance (CSA) updates from the Food and Drug Administration (FDA). In addition, Qualio is announcing ISO 9001 and 27001 certifications as part of its broader effort to help emerging life sciences companies optimize and streamline regulatory and compliance processes.

Qualio’s new Validation Pack will help life sciences companies adhere to the revised GAMP and CSA guidance. In addition, the Validation Pack offers key benefits to Qualio customers, including reduced onboarding time for the electronic quality management system (eQMS) as all functional testing is completed for the user; accelerated adoption of new and updated eQMS features; and a reduction in unnecessary documentation so more time can be spent on patient safety and product quality adherence.

When asked about the benefits of Qualio’s Validation Pack and software platform, Daniel Aragao, a Qualio customer and chief technology officer at InVivo Bionics, said, “The life science industry has been entrenched in paper and resistant to adopting new digital tools for decades. But SaaS tools like Qualio can help these businesses on their journey. This type of digital transformation—being led by companies like Qualio, and even these latest regulatory guidance changes—are innovation enablers. Life science companies need to embrace these companies leading the charge. It’s a good change.”

The latest GAMP guidelines are focused on improving product quality and safety for manufacturers in the life sciences sector by making quality testing a specific consideration at each stage of the manufacturing process. These GAMP 5 revisions were driven by growing adoption of emerging software tools by life sciences leaders. The latest evolution from computerized system validation to CSA aligns closely with the GAMP guidance as well. CSA aims to make the adoption of compliant computerized system tools simpler and more streamlined. Essentially, the FDA is now encouraging life sciences companies to adopt an agile and risk-based assurance approach to the digital tools and best practices they adopt while continuing to prioritize patient safety.

“For too long, life science quality professionals have been unnecessarily spending time on nonvalue-added paper-based validation documentation that did not improve quality or compliance,” says Sion Wyn, GAMP 5 editor and computerized system compliance expert. “In this competitive market and with the volatile economic climate, regulators such as the FDA welcome life science companies adopting powerful new digital tools using a rapid, logical, scientific, and least burdensome approach—so they can focus on optimizing patient safety and public health outcomes, not generating unnecessary paperwork.”

In addition, Qualio is announcing its latest certifications for both ISO 9001:2015 (Quality Management System Requirements) and ISO 27001:2013 (Information Security Management System Requirements). Qualio has achieved certification for both its own eQMS and data security processes. As a result of these certifications, Qualio customers can rest assured that a third-party auditor agrees the company is a trusted, secure electronic quality management system provider for the life sciences.

“As a leading eQMS for the life sciences, it’s important that we practice what we preach when it comes to quality,” says Qualio founder and CEO Robert Fenton. “That’s why we’ve fast-tracked our efforts to fully embrace software automation for customers using our eQMS and related services, while also ensuring that we’re prioritizing industry international certification best practices so our customers can lean on us as their trusted, global eQMS partner.”

For more information on Qualio’s Validation Pack and latest ISO certifications, visit Qualio.com.


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For 40 years Quality Digest has been the go-to source for all things quality. Our newsletter, Quality Digest, shares expert commentary and relevant industry resources to assist our readers in their quest for continuous improvement. Our website includes every column and article from the newsletter since May 2009 as well as back issues of Quality Digest magazine to August 1995. We are committed to promoting a view wherein quality is not a niche, but an integral part of every phase of manufacturing and services.