Quark and Glemser prescribe structured authoring as part of content automation to help pharmaceutical companies comply with regulations

0

GRAND RAPIDS, Mich., December 15, 2021 /PRNewswire/ — Quark Software today announced its strategic alliance with Glemser, a provider of IT solutions and services to the global life sciences and pharmaceutical industry. Software vendors help companies in this particular vertical market comply with regulations, while improving quality, gaining operational efficiency and reducing costs.

Improvements to Global Labeling and Identification of Medicines Readiness (IDMP), a set of International Organization for Standardization (ISO) standards for describing marketed medicines to improve patient safety, is pushing pharmaceutical companies to re-examine their data processes. The European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) are moving towards mandatory IDMP compliance, so the time frame for pharmaceutical companies to submit their product data in the required IDMP format is tighten. The EMA expects pharmaceutical organizations under its oversight to be IDMP compliant by Q1 2023, with the FDA deadline not far behind.

Quark Publishing Platform NextGen (QPP NextGen) is part of Glemser ComplianceAuthorMT solution to automate the regulatory content lifecycle, including test specifications, analytical procedures, basic data sheets, global product labels and all related artwork. For example, a given pharmaceutical company may have to make over 30,000 label changes in a year, and complex label changes may take over a year. ComplianceAuthor makes creating, managing and publishing these pharmaceutical 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 are also reduced.

“Existing data supply chains are inadequate to meet modern information needs, and global competition, regulatory pressure and lack of institutional knowledge – largely due to mergers, acquisitions and divestitures – are impacting on our customers,” explained Dr. Ray Glemser, CEO of Glemser. “But these challenges create new opportunities for improving technologies and processes that ultimately benefit patients and the overall safety of the pharmaceutical supply chain. We’re excited to work with Quark to help customers create and manage their critical data, removing many of the inherent, labor-intensive complexities through content automation designed with compliance as a key objective. »

QPP NextGen is a SaaS-based content automation software for content creation, assembly/management, collaboration and omnichannel publishing. It includes Quark XML Author, a Microsoft Word plug-in that allows subject matter experts to create vetted, compliant, and reusable content components in the familiar word processing environment with XML automatically generated behind the scenes. With rich metadata markup, these components are easily searchable, version controlled, and dynamically assembled in 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 do within the pharmaceutical industry brings more attention to the benefits it offers in terms of accuracy, speed and regulatory compliance,” said Martin Owen, CEO of Quark. “User experience is also an important consideration given the high stakes, which is why authors and subject matter experts appreciate the ease and familiarity of a Microsoft plug-in. Built-in workflows simplify tasks paperwork, reporting and audit trails, and interactions with regulators.. We are truly proud of the work we do with Glemser and pharmaceutical customers.”

One project involves a European customer upgrading their global test specification system and streamlining these processes to meet CMC (chemistry, manufacturing and controls) and GMP (good manufacturing practices) compliance requirements, precursors to IDMP. Using Quark-Glemser technologies, it can manage global test specifications and analytical procedures for pharmaceutical ingredients as controlled compliance components with full audit trails. The main language can be linked to many translations managed and maintained in the repository. Roles/responsibilities and workflows, including electronic 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 lifecycle to streamline how they create, manage, and publish their investment prospectuses, product manuals, codes and standards, or any other complex document,” added Owen. “When regulatory compliance is a key consideration, the right technology is critical to managing information and publishing documents.”

About Glemser
Glemser develops industry-leading IT solutions and services that are essential for global life science customers to ensure quality, achieve regulatory compliance, and gain operational efficiencies that reduce costs. Glemser has been at the forefront of technology and customer service for over 30 years. For more information, visit http://www.glemser.com.

About Quark Software, Inc.
Quark provides content creation, automation and intelligence software. The company has pioneered content design, digital publishing and content automation since 1981, with today’s customers trusting Quark for closed-loop content lifecycle management. Based at Grand Rapids, Mich., we serve more than 100 enterprise customers and 50,000 users worldwide. Quark. Awesome content that works. For more information, visit www.quark.com.

SOURCEQuark

Share.

Comments are closed.