Every company, no matter what services or goods it produces, must deal with three most important values: time, price and quality. Customers choose to do business with organizations that have the ability to deliver excellence in quality in a timeframe that they wish for, and at a price point that is affordable. One thing that stands out in the end is the quality of product, as the customer experience lasts longer than the time or the price. An organization needs to have next generation…

Salesforce safety - ComplianceQuest is an Enterprise Quality, Safety and Environment Management (QHSE) solutions platform natively built and run on Salesforce technologies. We help our customers of all sizes deliver quality products and services in the safest, most sustainable way by mitigating risk, problems, and inefficiencies while protecting customers, employees, suppliers, and brands.

In May 2018, FDA first proposed revising its current Quality System Regulations (QSR) under 21 CFR Part 820 to more precisely align with the international ISO 13485:2016 standard as the basis for its quality system legislation. This signals an essential step forward for the international standard, which is already used globally. FDA ISO 13485 QMS standard for medical devices enables controlling…

Corrective and Preventive Action (CAPA) process helps an organization to analyze and collect relevant product-related information, investigate and identify product and quality problems, and trigger appropriate and effective corrective or preventive actions to eliminate a problem and prevent its recurrence. CAPA has two different components, corrective action and preventive action. Corrective…

The enterprise-wide quality management system from ComplianceQuest has a module dedicated to documentation workflow automation through a document management system software.

Centralize all your incident data, near misses, safety observations, investigations for implementing agile corrective actions with ComplianceQuest’s Health and Safety Incident Management Software.

Furthermore, mitigate risks and prevent accidents by detecting a hazardous trend ahead of time using built-in analytics, predictive intelligence, dashboards, and mobile capabilities. By instilling an…

The CQ Document Management Software, being a part of its enterprise-wide quality management system, empowers you to automate and manage your entire document lifecycle. It provides you with complete visibility throughout the document lifecycle and improve your decision making by providing a single source of truth across all locations.

Regulatory bodies are becoming more stringent about…

Environmental health and safety management is an all-in-one term that focuses on improving the EHS performance of a business. EHS management refers to the implementation of procedures focused on ensuring and improving the safety of workers and their surroundings. These processes play a significant role in achieving and maintaining the overall environmental goals of the organization. EHS…

CAPA (Corrective Action, Preventive Action) is a methodological strategy for mitigating risks and improving processes, identifying the sources of actual or potential issues and their root causes, planning solutions for those problems, and documenting the solution so that similar issues don’t occur in the future. CAPA is a way to improve the company’s processes by taking a series of actions…

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…

Change management solution is a structured, determined approach aimed to transform people, teams, and organizations from their present state to the desired future state.

Change management solution is essential for below practices:

1. Eliminate ongoing failures during the change as an opportunity for learning and promote an organizational culture that supports it.

2. Stay open…

To maintain the greatest transparency and ethical conduct with clients, customers, employees, and stakeholders, organizations must have a compliance training program to reduce risks, keep everyone updated, maintain trust, and decrease the chances of violating the law.

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…