Compliance Group

21 CFR 820.70 specifically deals with "Production and Process Controls" within the Quality System Regulation (QSR) for medical devices. These controls are crucial for ensuring that medical devices are manufactured in a consistent and controlled manner, meeting the required quality standards and specifications.   Here's a more detailed breakdown of what 21 CFR 820.70 covers:   1. General Requirements: Establishing and maintaining procedures to ensure that devices are manufactured in accordance with their specifications.   2. Production Processes: Documenting procedures for controlling production processes, including those related to equipment, materials, and personnel.   3. Process Validation : Validating production processes to ensure that they consistently produce devices meeting predetermined specifications.   4. Monitoring and Control: Establishing procedures for monitoring and controlling process parameters to ensure product quality and consistency.   5. E

Introduction: In the highly regulated and fast-paced world of Life Sciences, effective Application Lifecycle Management (ALM) is paramount for ensuring product quality, regulatory compliance, and speed to market. Polarion ALM emerges as a leading solution, offering a comprehensive platform tailored to the unique needs of Life Sciences organizations. This guide delves into the intricacies of Polarion ALM and its transformative impact on Life Sciences processes. What is Polarion ALM? Polarion ALM is an integrated solution that facilitates end-to-end management of software development processes, from requirements gathering to release and beyond. It offers robust features such as requirement management, test management, and traceability, empowering Life Sciences companies to navigate complex regulatory landscapes with ease.  Key Benefits of Polarion ALM in Life Sciences In the Life Sciences sector, where compliance with regulations like FDA 21 CFR Part 11 is non-negotiable, Polarion

Polarion ALM (Application Lifecycle Management) is a software platform developed by Siemens Digital Industries Software. It is designed to help organizations manage the entire lifecycle of software development, from requirements management to testing and release. Here are some key features and functionalities of Polarion ALM: polarion-alm-software Requirements Management: Polarion ALM allows users to capture, manage, and trace requirements throughout the software development lifecycle. It provides tools for defining requirements, linking them to related artifacts, and tracking changes and approvals. Collaboration and Workflow: The platform facilitates collaboration among team members by providing centralized access to project data, documents, and discussions. It supports customizable workflows for managing tasks, approvals, and notifications. Version Control : Polarion ALM integrates with version control systems such as Git and Subversion,

ISO 9001 is a widely recognized international standard for Quality Management Systems (QMS) . While ISO 9001 itself does not provide a checklist of requirements, it does outline specific criteria that organizations must meet to achieve certification. Scope of the Quality Management System (QMS): Determine the scope of your QMS, including the products, services, and processes it covers. Leadership: Demonstrate leadership commitment to the QMS. Establish a quality policy and quality objectives. Ensure the integration of quality objectives into the organization's strategic planning. Planning: Conduct risk-based thinking to identify and address risks and opportunities. Develop a quality management plan. Establish objectives to enhance customer satisfaction and meet quality requirements. Support: Provide adequate resources, including human resources, infrastructure, and

The U.S. FDA (Food and Drug Administration) provides guidance on process validation for the pharmaceutical industry. Process validation is a critical aspect of ensuring that a pharmaceutical manufacturing process consistently produces a product that meets its predefined quality attributes. The FDA's guidance on process validation emphasizes a lifecycle approach, which includes three stages: Stage 1: Process Design: This stage involves understanding the manufacturing process and defining critical quality attributes (CQAs) and critical process parameters (CPPs). During this stage, manufacturers design their processes to ensure that they can consistently produce products that meet quality requirements. Stage 2: Process Qualification: In this stage, the manufacturing process is evaluated to determine whether it can consistently produce product that meets predetermined specifications. Process qualification involves executing process performanc

  Software Quality Assurance (SQA) offers numerous benefits to software development projects, teams, and organizations. Here are some of them: Improved Product Quality : SQA ensures that the software meets specified requirements and standards, leading to higher quality products with fewer defects and issues. This results in increased customer satisfaction and better user experience. Cost Reduction : By identifying, rectifying, and fixing defects early in the software development process, SQA helps reduce the overall cost of development. It in turn prevents costly rework and de-bugging efforts during later stages of the project. Enhanced Customer Satisfaction : High-quality software that meets or exceeds user expectations leads to greater customer satisfaction. Satisfied customers are more likely to return for future purchases and recommend the product to others. Risk Mitigation : SQA helps identify and mitigate risks associated with sof