In May 2018, FDA first proposed revising its current Quality System Regulations (QSR) under 21 CFR Part 820 to more precisely align with the international ISO 13485:2016 standard as the basis for its quality system legislation. This signals an essential step forward for the international standard, which is already used globally. FDA ISO 13485 QMS standard for medical devices enables controlling…Continue
Added by Shalini on July 1, 2021 at 12:06am — No Comments
The FDA ensures that the quality of drugs manufactured at the facility is in compliance with cGMP regulation. cGMP compliance includes the implementation of modern quality systems and a robust risk approach that meets the 21 CFR part 210 and 211 of cGMP regulations. The primary goal is to encourage the adoption of modern manufacturing technologies.
Added by Shalini on June 28, 2021 at 1:54am — No Comments
Design controls are defined as an interrelated set of practices and procedures incorporated into the design and development process. FDA design control make 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…Continue
Added by Shalini on June 15, 2021 at 5:47am — No Comments
Design controls are an integral component of a comprehensive quality system that covers the life of a device. The assurance process includes a total systems approach from the development of device requirements through design, production, distribution, use, maintenance, and, eventually, obsolescence. Design control starts with the development and approval of design inputs and includes designing a device and the associated manufacturing processes.…Continue
Added by Shalini on June 15, 2021 at 5:43am — No Comments
Maintain proper records as part of OSHA guidelines. Documentation of workplace incidents, CAPA, and other workplace safety-related records are important to pass OSHA inspection.
Added by Shalini on June 1, 2021 at 2:21am — No Comments
OSHA inspectors are called compliance safety and health officers and are experienced, well-trained industrial hygienists and safety professionals. Their role is to assure compliance with OSHA requirements and help employers and workers reduce on-the-job hazards and prevent injuries, illnesses, and deaths in the workplace.
Added by Shalini on June 1, 2021 at 1:30am — No Comments
The pharmaceutical, life sciences, and healthcare industries are highly regulated due to their direct impact on customer health and safety. A Quality Management System designed specifically for these industries should address the complex product development lifecycle of these industries. A Quality Management System’s use in the organization is to ensure compliance with FDA and other ISO standards, specifically ISO 13485.…Continue
Added by Shalini on May 31, 2021 at 9:10am — No Comments
ComplianceQuest enables automating environment management through a Environmental Management System (EMS) that offers a range of tools to help reduce the effort in tracking, managing, and reporting. It provides data for informed decision-making to achieve corporate goals as well as comply with environmental regulatory standards. The reports generated will also aid in better planning of your…Continue
Added by Shalini on May 31, 2021 at 6:52am — No Comments
To ensure that the inspection process is completed successfully, follow these simple steps
1. Establish a process to be followed in case of OSHA inspection. The process must include an employee representative who will be accompanying the inspector during the walkaround.
2. Maintain proper records as part of OSHA guidelines. Documentation of workplace incidents, CAPA, and other…
Added by Shalini on May 31, 2021 at 5:11am — No Comments
Transform your document management to satisfy quality and regulatory compliance, from ISO 9001 to GxP standards. Manage all the documents in your workflows, while integrating with other quality processes critical to regulatory compliance, such as registration and surveillance audits, CAPA escalations, non-conformance, change control and customer complaints. Always be ‘audit ready,’ and ensure…Continue
Added by Shalini on May 31, 2021 at 2:55am — No Comments
A formal equipment inspection program is required to ensure that operators know what to inspect on any specific type of equipment. The program should incorporate comprehensive guidelines and checklists for each piece of equipment and make it available to operators. The guidelines should set up requirements for periodic inspections by mechanics and daily inspections by operators. Inspection documents can make…Continue
Added by Shalini on May 28, 2021 at 9:00am — No Comments
In today’s world, organizations experience changes whether it is caused by new technology implementations, compliance initiatives, process updates, reorganization, or customer service improvements. Change is constant and required for growth and profitability. A change control management process will reduce the impact on your organization and employees.
Added by Shalini on May 28, 2021 at 6:45am — No Comments
R structures are adapted to do more than just indicate existing potential risks. A risk management structure measures the uncertainties and predicts their impact on a business. As a result, it’s a choice between accepting risks or denying them. Acceptance or denial of risks is dependent on the tolerance levels that a business has already determined for itself.
Added by Shalini on May 28, 2021 at 5:57am — No Comments
By taking action for risk mitigation, the negative effects of threats and disasters on business continuity are minimized. Although the principle of risk mitigation is to prepare a business for all potential risks, a proper risk mitigation plan will assess the impact of each risk and prioritize planning around that impact. Ideally, an organization would be prepared for all risks and threats and avoid them…Continue
Added by Shalini on May 28, 2021 at 4:48am — No Comments
CQ’s Sustainability Management System, a key solution within CQ EHS platform, enables organizations to easily and effectively manage to collect, track, analyze, trend and report the key sustainability performance indicators.
Added by Shalini on May 28, 2021 at 2:47am — No Comments
In the modern world, the life sciences sector is going through a period of unprecedented regulatory change affecting organizations involved in pharmaceuticals, medical devices, and in-vitro diagnostics. The European Medical Device Regulation (EU MDR), a robust, transparent, predictable and sustainable regulatory framework for medical devices, ensures high standards of quality and safety being produced…Continue
Added by Shalini on May 28, 2021 at 2:09am — No Comments
Incident management is a set of procedures and actions taken to rectify crucial incidents and respond. It could include steps such as identification and communication of incidents, tools used, assigning responsibilities, and setting down steps or actions taken to solve the incident. Incident management processes are used across functions in an organization to centralize all incident data, near misses,…Continue
Added by Shalini on May 28, 2021 at 12:21am — No Comments
QMS system focuses on addressing the complex product development lifecycle. It is designed for various highly regulated industries such as pharmaceutical, biotech, and medical devices products. A sound QMS evaluates the set of policies, processes, and procedures of a company. Using this evaluation, organizations can improve the core business areas of the company such as production,…Continue
Added by Shalini on May 27, 2021 at 7:21am — No Comments
With CQ’s Audit Management Software, we ensure companies have the ability to build a flexible, scalable and configurable audit management workflow. Depending on the specific needs of your organization, you can automate a rapid audit process or configure a workflow for a complex audit.
Create, schedule and manage your audit program using the calendar view available in the CQ Audit Management…Continue
Added by Shalini on May 27, 2021 at 6:21am — No Comments
To improve health and safety in your enterprise and reduce the costs of avoidable illness and injury, companies must depend on good and timely data to focus on the areas of highest risk first and improve their health and safety program across the company.
Although a Health & Safety program is a very essential element, every workplace will need to adopt to safeguard its greatest asset – human resource – implementing a robust health & safety program gaining without the backing…Continue
Added by Shalini on May 27, 2021 at 5:03am — No Comments