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.

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.

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

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… Continue

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… Continue

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… Continue

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… Continue

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.

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… Continue

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… Continue