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.

The focus of design control is predominantly centered around the type of device, software used, materials required, and manufacturing process. Simply put, design control is focused on design input and output.

The FDA design control guidance discusses subjects in which they appear in the FDA’s Quality System Regulation. It is cross-referenced to International Organization for Standards (ISO) 9001:1994, Quality Systems Model for Quality Assurance in Design, Development, Production, Installation, and Servicing, and the ISO draft international standard ISO/DIS 13485, Quality Systems Medical…

An IATF 16949 audit checklist is a comprehensive list that quality managers use to evaluate if the company’s QMS is aligned to the IATF 16949:2016 standard. As IATF 16949 is applicable to automotive suppliers, the primary objective of the IATF 16949 audit checklist is to ensure that the QMS promotes defect prevention, continuous quality improvement, and waste reduction in…

FDA Adverse Event Reporting System (FAERS) is a useful tool for FDA to monitor various activities. FDA Adverse event reporting requirements include –

Looking out for new safety concerns that might be related to a marketed product
Evaluating a manufacturer’s compliance to reporting regulations
Responding to outside requests for information

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…

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. Industries including steel mills, food processing, construction, plastics manufacturing and automobile manufacturing must focus on equipment…

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…

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.

If a business puts risk management in place as a disciplined and continuous process with the intent of identifying and addressing risks, then the risk management structures can be used to support other mitigation systems including planning, organization, cost control, and budgeting.

Risks Response

Risks response takes one of the following forms:

Prevention: A business aims to remove a…

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…

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…

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 in or supplied into Europe. By improving the safety and performance of medical devices, the…

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,…

An EDMS lets you create, edit, process, revise, and store documents not just in text form but also in images, video, and audio files. Providing a single view of all the documentation, it also integrates scanning and printing features along with storage. One of the greatest benefits of having a well-designed EDMS is that it integrates with other applications such as your enterprise’s ERP and CRM, enabling you to…

For an organization that is fully committed to follow its QMS and continuous improvement, recertification will become a natural process step. However, many companies fail in maintaining ISO 9001 certification requirements and eventually lose the certified status during their next certification cycle. Typical reasons for such failure can be broadly categorized into: commitment,…

To ensure your organization has an ingrained culture of health and safety and follows the occupational health and safety administration requirements mandated, OSHA recommends the following practices:

1Make safety and health a priority while communicating with employees. Explain the OSHA safety practices implemented, and proactively fix any hazards that could…

Cloud-based solutions provide an assurance of business continuity and disaster recovery with ease. Also, even your mobile executives can access the documents from anywhere if they have the authorization to.

A good document management system software that promotes a quality culture aids in an improved customer relationship, competitiveness and flexibility. It improves supplier management…

OSHA regulations are rules that describe the methods employers are legally required to follow to protect their workers from hazards. Before OSHA can issue a standard, it must go through a very extensive and lengthy process that includes substantial public engagement, notice and comment. The agency must show that a significant risk to workers exists and that there are feasible measures employers can…

A software that lets you manage your documents is a document management software. Manage involves every step of the document lifecycle, right from its creation to publishing and storing, and its deletion if it has an expiry date. It allows you to scan and store the electronic version of paper documents and can also handle audio and video files. It lets all documents be tagged for easy…