A primary focus of the companies’ alliance is helping pharma streamline global label changes and approvals to prepare for ISO IDMP
GRAND RAPIDS, Mich. – Quark Software today announced its strategic alliance with Glemser, an IT solutions and services provider to the global life sciences and pharmaceutical industry. The software providers are helping enterprises in this particular vertical market achieve regulatory compliance, while also improving quality, gaining operational efficiencies, and reducing costs.
Global labeling improvements and readiness for Identification of Medicinal Products (IDMP), a set of standards from the International Organization for Standardization (ISO) for the description of marketed medicinal products to improve patient safety, are driving pharmaceutical companies to re-examine their data processes. Both the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) are moving toward mandatory IDMP compliance, so the timeframe for pharma companies to submit their product data in the required IDMP format is tightening. EMA expects pharma organizations within its oversight to comply with IDMP by Q1 2023, with the FDA’s deadline not far behind.
Quark Publishing Platform NextGen (QPP NextGen) is part of the Glemser ComplianceAuthorTM solution for automating the regulatory content lifecycle, including testing specifications, analytical procedures, core data sheets, global product labels and all associated artwork. For example, a given pharmaceutical company might have to make more than 30,000 label changes during the course of a year, and complex label changes can take more than a year. ComplianceAuthor makes creating, managing and publishing such pharma documents easier, faster and more cost-effective. The solution is also an overlay that aggregates information from legacy systems, so implementation costs and time to value also are reduced.
“Existing data supply chains are inadequate for meeting modern information needs, plus global competition, regulatory pressure, and lack of institutional knowledge – due in large part to mergers, acquisitions and divestitures – are impacting our clients,” explained Dr. Ray Glemser, CEO of Glemser. “But these challenges lead to new opportunities to improve the technologies and processes that ultimately benefit patients and the overall safety of the pharmaceutical supply chain. We’re pleased to be working with Quark to help clients author and manage their mission-critical data, removing many of the inherent and labor-intensive complexities through content automation that is engineered with compliance as the key objective.”
QPP NextGen is SaaS-based content automation software for content creation, assembly/management, collaboration and omnichannel publishing. It includes Quark XML Author, a Microsoft Word plugin that enables subject-matter experts to create controlled, compliant and reusable content components in the familiar word-processing environment with XML generated automatically in the background. With rich metadata tagging, these components are easily searched, version-controlled and dynamically assembled within a central repository for any document output in any format, such as SPL.
“Quark has been in the content automation business since 2015, but our partnership with Glemser and the work we’re doing within the pharma industry is bringing more attention to the benefits it provides in terms of accuracy, speed and regulatory compliance,” said Martin Owen, Quark’s CEO. “User experience is also an important consideration given the high stakes involved, which is why authors and subject-matter experts appreciate the ease and familiarity of a Microsoft plugin. Built-in workflows simplify administrative tasks, reporting and audit trails, and interactions with regulators. We’re really proud of the work we’re doing with Glemser and pharma clients.”
One project involves a European client upgrading its global test specification system and streamlining those processes to meet CMC (Chemistry, Manufacturing and Controls) and GMP (Good Manufacturing Practices) compliance requirements, precursors to IDMP. By using the Quark-Glemser technologies, it can manage global test specifications and analytical procedures for pharma ingredients as controlled compliance components with complete audit trails. The primary language can be linked to many translations managed and maintained within the repository. Roles/responsibilities and workflows, including e-signatures, are established for reviews, approvals and audits, including interactions with and feedback from the governing health authority.
Quark also works in financial services, manufacturing, government and other industries. “With QPP, large enterprises automate their entire content lifecycles to streamline how they create, manage and publish their investment prospectuses, product manuals, codes and standards, or any other complex documents,” Owen added. “When regulatory compliance is a key consideration, the right technology is essential to information management and document publishing.”
Glemser develops industry-leading IT solutions and services that are essential for global life sciences clients to ensure quality, achieve regulatory compliance, and gain operational efficiencies that reduce costs. Glemser has been on the cutting edge of technology and client service for more than 30 years. For more information, visit www.glemser.com.