Within laboratories, document management is the cornerstone of a comprehensive quality management system. Q-Pulse not only ensures security and accessibility to your system for all users, but also promotes a culture of shared responsibility and individual accountability for compliance. Furthermore, Q-Pulse simplifies: audit management; the reporting, recording and managing of incidents; and the subsequent follow-up of outstanding actions.
To allow Medical Device companies to demonstrate high levels of quality and compliance, organizations are legally required to comply with a number of international standards and regulations from ISO and the FDA.
Achieving and maintaining compliance with the FDA’s 21 CFR 820, ISO 13485, ISO 14971, Medical Devices Directive or EU GMP requirements is of vital importance, and having a software system to effectively manage and maintain regulatory compliance, and adapt to business processes, is very important to the Medical Devices industry.
To allow biotechnology companies to demonstrate high levels of quality and compliance, organizations are legally required to comply with a number of international standards and regulations such as ISO, the FDA…
…(including 21 CFR Part 11), US Environmental Protection Agency (EPA), US Department of Agriculture (USDA) and MHRA.
Achieving and maintaining compliance with these regulatory bodies is vitally important, and having a software system to effectively manage and maintain regulatory compliance, with an ability to adapt to a company’s business processes, is very important to the biotechnology industry.
A central, electronic quality management system to streamline their compliance and quality processes, Q-Pulse enables biotechnology organizations to manage Document Control, Audits, Training and Staff Competency, Corrective/Preventive Actions (CAPA) or Deviation processes, more effectively.
Blood and Biologies
Blood Services and Biologics organizations worldwide use Q-Pulse to help ensure the collection, testing, processing, storage and distribution of blood, tissues and biological therapies is performed in a robust quality-assured environment.
Achieving and maintaining compliance with the numerous regulations and standards such as the FDA’s 21 CFR, AABB, CLIA-88, the EU Blood Directive,NetCord-FACT,ISO 15189,ISO 17125, HTA and HFEA requires time and money. Strict quality and safety requirements demanded by these regulators means organizations must implement an effective system to integrate and centralise all quality processes and procedures.
Q-Pulse, from Gael, is a fully integrated Quality Management Solution that helps organizations significantly decrease the time and cost spent managing critical processes including, Document Control, Corrective and Preventive Actions (CA/PA), Internal and External Audits, Training and Competency, Customer Feedback and Supplier Management.
Q-Pulse has been designed to be flexible enough to assist with regulation and compliance management in a number of areas within the Pharmaceutical market sector including – Pharmaceutical Research and Development,…
…Contract Research Organizations (CROs), Clinical Trials, Pharmaceutical Manufacturing, and Pharmacovigilance.
Across these pharmaceutical disciplines, our customers are required to comply with multiple standards and regulations.
To help ensure they meet those strict guidelines and standards, a Regulatory Compliance Management Software Solution is required to effectively manage compliance activities such as Document Control, CA/PA and Audit in order to meet and maintain regulatory requirements.