Regulations

21 CFR Part 11 is the FDA guideline that defines the criteria under which electronic records and electronic signatures are considered to be trustworthy, reliable and equivalent to that of the paper records.

FDA software validation is a requirement of the FDA Quality System Regulation, which was published in the Federal Register on October 7, 1996, and took effect on June 1, 1997.

Manufacturing processes and supply chain management that were once easy to handle are now much more complex. What used to be controlled and contained within the manufacturing plant is now monitored, run and maintained globally.

AS 9100 provides the framework for a robust quality management system that uses ISO 9000 as a baseline. AS 9100 also defines additional areas within an aerospace quality management system that must be addressed when implementing an ISO 9001 based quality system.

IATF 16949 (previously called ISO/TS 16949) applies to any organization active in the automotive/motorcycle supply chain.

ISO 13485 standard is an effective solution to meet the comprehensive requirements for a Quality Management System.

ISO 14001 was developed primarily to assist companies with a framework for better management control that can result in reducing their environmental impacts.

Introducing ISO 45001, a new workplace safety standard that replaced OHSAS 18001 at the end of 2017.

The Occupational Safety and Health Act of 1970 states that employers are responsible for providing a safe and healthful workplace. This ideology is implemented by enforcing standards, training, and assistance. OSHA’s commitment to workplace safety grants the committee jurisdiction over seven million worksites.

Occupational Safety and Health Act of 1970 provides guidelines for ensuring workplace safety for employees and the environment. To ensure compliance, OSHA also conducts periodic inspections to ensure compliance.

OSHA was established to assure safe and healthful conditions for working men and women by setting and enforcing standards and providing training, outreach, education, and compliance assistance. Under the OSHA law, employers are responsible for providing a safe and healthful workplace for their workers.

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.

Occupational Health and Safety (OHS) management systems help companies and organizations automate and digitize health and safety-related workflows. OHS includes health and safety policies, systems, standards, and records, and includes incorporating health and safety activities and programs into key business processes.

Making the workplace a safe place for employees while implementing sustainable practices is a multi-step process requiring right from top management commitment to employee involvement. It needs a strong safety and environment culture and also processes to ensure the efforts bear fruit. Most importantly, the processes should comply with regulatory requirements such as os OSHA Occupational Safety and Health Act of 1970.

FDA’s 21 CFR Part 11 is a regulatory framework guiding companies on creating and managing digital records and signatures. Facilitating regulatory oversight is the core focus of 21 CFR Part 11, while the driving force is to ease the cost and burden of maintaining paper records to satisfy regulators.

IATF 16949:2016, which replaced ISO/TS 16949:2009, is an independent standard for Quality Management System (QMS) applicable to the automotive sector. Aligned to the requirements of ISO 9001:2015, it focuses on continual improvements, particularly defect prevention, reduction of waste and preventing variation in the supply chain.

The European Union 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 in or supplied into Europe

OSHA Form 300 is the official log where an organization can document the details of all the occupational injuries and illnesses including injured employee’s name, job title, etc that occur in the workplace to maintain compliance and avoid fines. OSHA Form 300A is the summary report of all occupational injuries and illnesses beyond each individual case.

OSHA requires companies with 10 or more full-time employees to log all work-related injuries and illnesses yearly. Called OSHA Form 300 or the OSHA Log of Injuries and Illnesses, it is a log of all reportable injuries and illnesses occurring in the workplace.