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…
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Added by Shalini on June 22, 2022 at 6:57am —
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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 —
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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…
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Added by Shalini on June 22, 2022 at 6:45am —
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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…
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Added by Shalini on June 22, 2022 at 6:32am —
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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 —
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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…
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Added by Shalini on June 22, 2022 at 6:11am —
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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 —
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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…
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Added by Shalini on June 22, 2022 at 5:56am —
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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…
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Added by Shalini on June 22, 2022 at 5:48am —
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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…
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Added by Shalini on June 22, 2022 at 5:34am —
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Change control management system refers to the controlled set of actions to ensure that a change does not negatively impact a product’s safety, quality or compliance. The control may be proactive or reactive, as a response to mitigate or eliminate the consequences of unplanned change, also known as deviation.
Added by Shalini on May 11, 2022 at 6:08am —
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EHS Management (Environment, Health and Safety) is a crucial aspect of an enterprise’s operations. It not only helps minimize the impact on the environment and improve worker safety and well-being but also can improve employee retention, productivity, and enhance the brand image of the company spurring customer and corporate growth.
Added by Shalini on May 11, 2022 at 6:05am —
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ISO 45001 management is an International Standard for Occupational Health and Safety Management Systems that provides a practical solution for organizations to improve the safety and health of employees and other personnel proactively and prevent injury and ill-health. ISO 45001 is applicable to any organization regardless of its size, nature, and type
Added by Shalini on May 11, 2022 at 6:03am —
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An effective
quality solution acts as a single source of truth for both product life-cycle management and quality design records. Doing this in the cloud makes it easier to integrate all operations end-to-end, including the supply chain, internal teams, and auditors, providing visibility and traceability of all processes and documents. Thus, it results in reducing confusion, friction, and risks. QMS software boosts…
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Added by Shalini on May 11, 2022 at 5:57am —
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Employers, whatever their size, are responsible for the safety and health of their employees at the workplace. While this is mandated by the Occupational Safety and Health Act of 1970, those employers who implement safety practices as a moral responsibility benefit from greater employee loyalty and total employee involvement. They can avoid losses due to compensations and litigation. Needless to say, injuries or death in the workplace can damage the reputation of the business. There is also the…
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Added by Shalini on May 11, 2022 at 5:53am —
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Training Compliance Management refers to handling or tracking various training modules that companies must mandate to ensure all employees are trained in their area of work, understand the processes of the company, and remain compliant with various regulations mandated by OSHA, ISO, or FDA. Training Compliance Management Solution allows businesses to identify training gaps, missed deadlines, and remedy…
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Added by Shalini on May 11, 2022 at 5:48am —
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Design control starts with the development and approval of design inputs and includes designing a device and the associated manufacturing processes. 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…
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Added by Shalini on May 11, 2022 at 5:43am —
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An organization can have a variety of documents and in a variety of forms. Filing and storing those, retrieving them when needed, revising and approving as well as destroying them once their validity is over are tasks that are time and space consuming and hard to keep track of. To manage and maintain the documents, a business needs
document management software.
Added by Shalini on May 11, 2022 at 5:25am —
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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 the 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…
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Added by Shalini on May 11, 2022 at 5:16am —
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ISO 9001 Quality Management System is an international standard that details the quality and regulatory requirements for an organization to continuously track and improve products.
Implementing QMS ISO 9001 helps improve overall efficiency and productivity while boosting employee morale.
A part of the ISO 9000 family of standards, ISO 9001 defines requirements for a Quality…
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Added by Shalini on May 6, 2022 at 5:18am —
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