Life Sciences and Regulated Industries

Companies under Life Sciences can vary from the manufacturing of pharmaceuticals to biotechnology-based food and medicines, medical devices, biomedical technologies, food processing, research and development, etc.

IntellaQuest’s integrated QMS and EHS Management System can help companies operating in Life Sciences while maintaining compliance standards with:

IntellaQuest provides a Quality Management System which is a  completely integrated single system for Life Sciences enterprise-level QMS. It provides a seamless management of all key needs of a QMS: non-conformance, complaints, CAPA, Document Control, Audit, Supplier Quality, Training, and Management of Control, etc.

The core solution set includes DocuQuest, PeopleQuest, PRRQuest & AuditQuest which help Life Science companies to:

  • Eliminate Data Silos
  • Optimize their Processes
  • Elevate their Customer Focus
  • Drive Innovation with Continuous Improvement
  • Create mutually beneficial Supplier Relationships
  • Leverage data for a factual approach to decision making

Latest Life Sciences and Regulated Industries Articles

Transitioning 510(k) Submissions to eSTAR – Are You Ready?

The FDA's new electronic Submission Template And Resource (eSTAR) is revolutionizing the 510(k) submission process for medical devices. This interactive PDF form not only streamlines the submission process but also integrates multiple resources, ensuring a comprehensive and high-quality submission. With the mandatory transition to eSTAR submissions starting October 1, 2023, it's crucial for medical device manufacturers to familiarize themselves with this tool.

FDA Issues New Draft Guidance Documents to Strengthen the 510(k) Program for Medical Devices

The FDA has unveiled three new draft guidance documents aimed at refining the 510(k) Program for medical devices. These documents, part of the FDA's ongoing efforts to enhance the clarity and consistency of the 510(k) Program, emphasize the importance of selecting appropriate predicate devices, the use of clinical data, and setting evidentiary expectations for implant devices. As the regulatory landscape evolves, the significance of a robust Quality Management System (QMS) becomes even more paramount. A well-implemented QMS not only ensures compliance but also fosters a culture of continuous improvement and quality.

Harmonizing Global Standards: Navigating MDSAP, ISO 13485, and the Role of Intelligent QMS Solutions

The Medical Device Single Audit Program (MDSAP) represents a pivotal shift in the medical device industry's regulatory landscape, aiming to streamline global requirements through a unified audit process. Developed by the International Medical Device Regulators Forum (IMDRF) and rooted in principles of the ISO 13485 standard, MDSAP offers manufacturers the chance to satisfy multiple jurisdictional requirements with a single audit. This overview delves into MDSAP’s origins, its alignment with ISO 13485, the certification scheme, challenges in implementation, and recurrent audit findings, offering insights for firms navigating this comprehensive regulatory program.
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