Socially responsible organizations manage their impact on the environment, promote social responsibility, and comply with government regulations on emissions, renewable resources, and recycling. To do this consistently across all locations in a harmonized manner is not an easy task. Keeping up with the environmental regulations that is constantly changing makes reaching the sustainability goals even harder. CQ’s…

Risk mitigation is a systematic process where an organization develops actions and options to increase opportunities and reduce threats to project objectives. Risk mitigation implementation refers to the process of risk mitigation actions. Risk mitigation progress monitoring tracks identified, new and existing risks, and evaluates the risk process effectiveness throughout the project.

By taking…

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.

The important features of change control include:

A plan that identifies…

In business parlance, right from mechanical assets to heavy off-road vehicles and computer systems can be categorized as equipment. Equipment maintenance is a process that ensures the reliability of the asset through routine upkeep and corrective repair work.

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…

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…

The FDA Adverse Event Reporting System (FAERS) is a database that contains information on adverse events and medication error reports submitted to FDA. Compliant with the reporting guidance ICH E2B2 issued by the International Conference on Harmonisation, FDA uses FAERS data to monitor, identify and analyze adverse events and medication errors. The FAERS database, which follows FDA Adverse event…

Being IATF 16949 compliant is not a regulatory requirement but can also benefit the businesses by improving processes and efficiency that drives cost savings. Besides ensuring customer satisfaction and improvement, some of the other advantages to get IATF 16949 certification include—

Reduced operating costs

Improved stakeholder relationships

Proven business…

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…

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…

A compliance audit assesses how well an organization adheres to internal bylaws, rules and regulations, standards, and even codes of conduct. An audit also reviews the effectiveness of an organization’s internal controls using multiple types of audits.
External agencies such as regulatory bodies too conduct compliance audits to assess a business’s adherence to regulations governing that industry.

GxP compliance ensures that the product under development meets requirements and is fit for the intended purpose. Applying relevant GxP process regulations is necessary for highly regulated industries.

Good Manufacturing Practices (GMP)

GMP addresses issues around cleanliness, valid process usage, handling complaints, sanitation, hygiene, record keeping, and personnel…

An Effective CAPA FDA and CAPA Quality Plan For Easy Implementation, Reducing Defects and Lowering Penalty Costs.

A CAPA plan is a quality management strategy used in the manufacturing and production industries to identify and rectify defects to ensure they won’t repeat again in the future. Once a CAPA plan is implemented, it must illustrate ten objectives to meet the intent of the FDA 21 CFR 820.100…

FDA training is necessary to remain compliant. It makes employees keep abreast of the current regulations and guidance and how to adhere to them. The FDA training program includes various subjects — from conducting inspections to responding to 483s or warning letters.

Regulatory compliance training helps create awareness about the regulatory requirements. The training also prepares employees to…

ISO 9000 quality standards urge all companies to document and execute employee ISO training. Other ISO standards also require related training and documentation control. Are you aware of how well your company manages ISO training and other types of instruction? Is it tough to attend meetings and follow-up with employees that missed training activities or failed exams? Is an audit trail of ISO training…

The ISO 45001 certification provides a framework for improving worker safety across the globe. The below steps summarize the measures that safety professionals can take to begin implementing ISO 45001

Understand OHSMS (Occupational Health and Safety Management Systems) and ISO 45001

The initial step in implementing ISO 45001, or any standard for that matter, is…

Quality managers use ISO 13485:2016 audit checklist to determine if the QMS aligns with the ISO 13485 software standard requirements. The ISO 13485 audit checklist is used for internal audit while preparing the system for a third-party ISO 13485 certification audit. The ISO 13485 audit checklist allows quality managers to document evidence of compliance based on processes, standard…

ISO 14001 Certification is a reliable, effective, and responsible environmental management system for business operations. The amount of human labor, time, and resources to create and implement a total EMS solution is excessively onerous for many businesses. Therefore, to provide the infrastructure to achieve ISO 14001, most EHS experts are trying to meet ISO 14001 standards relying on an…

An ISO 14001 audit is an integral part of the ISO 14001 Environmental Management System (EMS) implementation. ISO 14001 audit involves an independent, systematic, objective, and documented process to gather facts that help identify areas for improvement and ensure that the organization incorporates the best practice processes that protect the environment

What are the different types…

Environmental Compliance is a comprehensive term encompassing a variety of sustainability goals and requiring meeting different legislations to different aspects of the environment. In the US alone, there is the Environment Protection Agency, Clean Air Act, Clean Water Act, Resource Conservation and Recovery Act (RCRA), Stormwater Clean Water Act to name but a few. Compliance with these acts is not only…