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Shalini's Blog – June 2022 Archive (13)

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JSA (Job Safety Analysis) - ComplianceQuest

Job safety analysis (JSA) is a procedure that helps integrate accepted safety and health practices into a particular task or job operation. In JSA, the ultimate goal is to identify potential hazards in every step of a process and recommend the safest way to execute the job. JSA is a written procedure developed to understand, review, minimize or eliminate hazards associated with work processes.

Added by Shalini on June 22, 2022 at 7:04am — No Comments

Complaint Handling System - ComplianceQuest

Every organization needs a robust complaint handling system to improve the complaint management process. Organizations can track each complaint through its lifecycle from recording and initiation to an investigation, regulatory assessment reporting, and closure with the help of ComplianceQuest’s Complaint Management System. By optimizing with an intelligent platform, CQ also enables the continuous… Continue

Added by Shalini on June 22, 2022 at 7:02am — No Comments

CAPA FDA & CAPA Quality - An Effective CAPA Plan

Implementing the two functions of CAPA FDA, the Corrective Action Preventive Action, approach are as follows:



Corrective Action

When an issue is identified or communicated, a structured set of activities are initiated to describe the problem in detail so that the team can identify a root cause path. After selecting a root cause path, a permanent corrective action is identified, implemented and… Continue

Added by Shalini on June 22, 2022 at 6:59am — No Comments

ISO 9001 Quality Management System

A 100% modern cloud Enterprise Quality & Safety Management System (QHSE) focuses on the requirements for ISO 9001:2015 while automating the entire ISO 9001 Quality Management System requirements. CQ QMS significantly reduces the effort involved in maintaining the ISO 9001:2015 Quality System by automating the required processes while maintaining full traceability. Also, CQ Quality… Continue

Added by Shalini on June 22, 2022 at 6:57am — No Comments

Design Control for Medical Devices

Design control focuses on all aspects of designing a product and the implementation of the design. Some of the tools and techniques that can be used are described in the guidance. Although aspects of their utility are sometimes described, they are only included in the guidance for illustrative purposes.

Added by Shalini on June 22, 2022 at 6:47am — No Comments

FDA Design Control and Design Control Process

FDA design control makes a systematic assessment of the design an integral part of development. With design control, any deficiencies in design input requirements or discrepancies between the proposed designs and requirements are detected early and corrected immediately in the development process. Design controls intend to increase the chances of transferring the design to production, without much… Continue

Added by Shalini on June 22, 2022 at 6:45am — No Comments

Why is cGMP (Current Good Manufacturing Practices) Compliance Important?

cGMP compliance assures consumers that the drugs are manufactured following the stipulated quality practices. As cGMP emphasizes quality control, the facilities are built as per a regulated design and manufacturing process. The FDA emphasizes the need for cGMP compliance to ensure the drugs that reach the market are safe for consumption. Notably, the recent cGMP regulations were published in 2016. cGMP compliance… Continue

Added by Shalini on June 22, 2022 at 6:32am — No Comments

Defining FDA ISO 13485

FDA ISO 13485 QMS standard for medical devices enables controlling processes to ensure that the end product meets the desired quality and safety requirements.

Manufacturers who have not addressed ISO 13485 should start assessing their QMS to find out whether there are any gaps to meet the ISO 13485 guidelines and realign processes for compliance.

Added by Shalini on June 22, 2022 at 6:16am — No Comments

Quality Management System - QMS Software

A sound quality management system (QMS Software) aims to help coordinate and align an organization’s activities to uphold the customer and regulatory requirements while focusing on improving effectiveness and efficiency on a continuous basis. While the concept of quality management is not new, there are several concerns over how beneficial QMS is to the company and the steps involved in… Continue

Added by Shalini on June 22, 2022 at 6:11am — No Comments

Best practices in Quality Management

Benefits of following best practices in quality management include –

Reduced costs and better cost management
Higher profitability
Increased customer loyalty and retention
Improved employee morale
Better adaptability to changing or emerging market conditions, environmental and other government regulations

Added by Shalini on June 22, 2022 at 6:09am — No Comments

Health and Safety Incident Management Software

Centralize all your incident data, near misses, safety observations, and investigations for implementing agile corrective actions with ComplianceQuest’s Health and Safety Incident Management Solution.



Furthermore, mitigate risks and prevent accidents by detecting a hazardous trend ahead of time using built-in analytics, predictive intelligence, dashboards, and mobile… Continue

Added by Shalini on June 22, 2022 at 5:56am — No Comments

Quality Management System - QMS Software

A sound quality management system (QMS Software) aims to help coordinate and align an organization’s activities to uphold the customer and regulatory requirements while focusing on improving effectiveness and efficiency on a continuous basis. While the concept of quality management is not new, there are several concerns over how beneficial QMS is to the company and the steps involved in… Continue

Added by Shalini on June 22, 2022 at 5:48am — No Comments

EHS - Environmental Health and Safety Management System

Environment, health, and safety management is an all-in-one term that focuses on improving the EHS performance of a business. EHS management refers to the implementation of procedures focused on ensuring and improving the safety of workers and their surroundings. These processes play a significant role in achieving and maintaining the overall environmental goals of the organization. EHS Management… Continue

Added by Shalini on June 22, 2022 at 5:34am — No Comments

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