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…