Qualio Launches Modern Validation Pack for the Life Sciences To Accelerate and Safeguard Quality and Compliance Processes
Qualio the trusted cloud quality management system software for the entire life sciences ecosystem — is announcing availability of their Validation Pack, which will 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 & Drug Administration (FDA). In addition, Qualio is announcing ISO 9001 and 27001 certifications as part of their 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, Chief Technology Officer at InVivo Bionics and a Qualio customer, shared the following: “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 non-value-added paper-based validation documentation that did not improve quality or compliance,” said 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 their latest International Standards Organization (ISO) 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 their 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,” said Robert Fenton, Founder and CEO of Qualio. “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.”
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