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.…

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…

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…

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…

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.

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.

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…

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.

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…

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,…

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,…

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…

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…

Change is everywhere, and can be initiated from anywhere in your organization. CQ Change Management software allows you and your supply chain partners to establish and follow best practice workflows to address the entire change management lifecycle. The software supports each aspect of your own change management process from initiation and review/approval through to execution tracking,…

GMP training is a requirement as it emphasizes employees performing all the tasks in accordance with GMP expectations and established procedures. GMP training is an essential requirement for pharmaceutical manufacturers as per 21 CFR 211.25 (a) – Personnel Qualifications. The GMP training is mandatory for both drug manufacturers and ingredient suppliers. Notably, GMP training and certification are considered a…

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…

Maintain a centralized repository of identified risks at the project, department, or company level with CQ Risk Management Software. Drive strategic decisions on potential threats with the solution that is aligned with the latest standards (ISO 31000, ISO 14971, ICH Q9 and risk principles in ISO 9001:2015, ISO 13485:2016, ISO 45001 and ISO 14001) to help accelerate assessments, identify and analyze risk trends and drive risk mitigation activities. Identify the right approaches that…

With CQ Document Management, you can manage the entire document lifecycle, gain complete visibility and rely on a single source of truth across all locations for more effective decision making.

Regulatory compliance is stringent. With an electronic approach to document management across the enterprise, you’ll have a central repository to create, modify, review, approve, store, organize, access…

Another critical component of OSHA is reporting. Employers in highly hazardous industries are mandated to keep records of serious work-related injuries and illnesses. OSHA’s record-keeping regulations are based on the framework from the national occupational safety and health record-keeping system. OSHA workplace safety adheres to a structured reporting requirement that…