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Shalini's Blog (295)

A Comprehensive Safety Investigation Process

The safety investigation process is a formal process for investigating a workplace incident, including a fatality, injury, illness, or close call. This enables you to discover hazards in business operations and drawbacks in health and safety programs. With the learnings from the investigation, you can implement appropriate corrective and preventive actions to avoid future incidents.… Continue

Added by Shalini on October 13, 2022 at 6:32am — No Comments

Non-Conformance Corrective Action vs Preventive Action (NC CAPA)

A good NC CAPA system must be data-driven and collaborative, allowing for easy approvals, verification, and final closure after corrective and /or preventive action has been taken.

Added by Shalini on October 13, 2022 at 2:51am — No Comments

Calibration Management and Maintenance Software

A defect in a piece of equipment can cause a ripple effect on the entire company, right from increased downtime, cost to, ultimately, brand image. Earlier, businesses used spreadsheets to track and maintain various types of equipment. With companies expanding geographically, this manual equipment management process became ineffective as it was time-consuming and inconsistent. Technology developments helped companies move from siloed, paper-based systems to a more robust, cloud-based… Continue

Added by Shalini on October 13, 2022 at 2:08am — No Comments

Efficient laboratory investigations

CQ’s Laboratory Investigation solution was built with consistency and thoroughness in mind. With guided workflows and built-in checklists, you can ensure your QA and QC consistently conduct comprehensive investigations and identify the correct assignable or root cause every time.

Added by Shalini on October 4, 2022 at 3:20am — No Comments

What is a Supplier Corrective Action Request?

A Supplier Corrective Action Request (SCAR) is a formal request given by an organization to its supplier requesting the rectification of an issue associated with quality or non-compliance with a regulation. SCAR is issued to address the root cause of the issue and prevent a recurrence.

Added by Shalini on October 4, 2022 at 3:03am — No Comments

What is Out of Trend (OOT)?

Out of trend is defined as a result of a sequence of the analytical results which conform to the specifications but not in the expected trend with respect to the initial or expected result. OOT reveals that there may be a problem with the analysis or the production process. The main purpose of OOT is to lay down a procedure for managing out-of-trend results in active raw material, finished… Continue

Added by Shalini on October 4, 2022 at 2:40am — No Comments

What is Design Project Management?

Design Project Management is a comprehensive development process that accounts for every part, design requirement, design input, user need, and product risk during the design lifecycle. With design project management, manufacturers can have end-to-end control over the design aspects of any project. With design project management, the project manager can define the project’s goals, assign and… Continue

Added by Shalini on October 4, 2022 at 2:11am — No Comments

ComplianceQuest Workplace Risk Assessment Software

CQ’s Workplace Risk Assessment Software has an in-built Risk Management Solution that integrates with modules such as Observations, Incident Management, Supplier, Management Review, and Permit to Work. The solution also complies with the latest standards, including ISO 31000, ISO 14971, ICH Q9 and risk principles in ISO 9001:2015, ISO 13485:2016, ISO 45001 and ISO 14001.

Added by Shalini on October 4, 2022 at 12:54am — No Comments

Equipment Maintenance Software - ComplianceQuest

Equipment Maintenance Software tracks equipment usage and performance efficiency and schedules preventative and corrective maintenance. The solution handles maintenance requirements based on date, use, and throughput. One of the essential aspects of Equipment Maintenance Software is to ensure that the users adhere to proper equipment calibration and maintenance schedules.

Added by Shalini on October 3, 2022 at 7:47am — No Comments

Supply Chain Quality Management Software

Supply chain quality management software offers visibility into processes, vendor performance, communication, and collaboration. Supplier Management Software helps take control of Supplier Quality across all locations. The supply chain quality management software can be used to assess, qualify, onboard, and collaborate effectively. In case of discrepancies, the software includes features for… Continue

Added by Shalini on October 3, 2022 at 6:35am — No Comments

Phase 1 Investigation and Phase 2 Investigation

Phase 1 investigation refers to accessing laboratory data, an analyst, and the supervisor verifies initial preparation. Phase 2 Investigation is conducted when the initial investigation clears laboratory error cause for the OOS result.

The Current Good Manufacturing Practice for Finished Pharmaceuticals (211.192 production record reviews) requires the quality control team to… Continue

Added by Shalini on August 24, 2022 at 8:23am — No Comments

Investigation Management Software

Investigation Management Software aligns with all major regulations, thereby improving compliance and facilitating QA and QC teams to ensure guidance by providing pre-built workflows and customizable checklists.



While ensuring systematic, comprehensive, and efficient investigations, Investigation Management Software also offers collaboration tools and guided workflows… Continue

Added by Shalini on August 24, 2022 at 5:23am — No Comments

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

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