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5 products found
Most compliance initiatives start as projects as companies race to meet the deadlines to comply with a specific regulation. However, compliance is not a one-time event and organizations are redesigning their compliance programs to make them repeatable process that can be sustained cost-effectively.Traditionally, homegrown systems, stand-alone applications, or even manual paper-based systems have been used to manage various compliance processes at the...
Effective Corrective & Preventive Action (CAPA) and remediation management of quality, compliance and risk related issues is essential for a closed loop, continuous improvement process. Relying on stand-alone point solutions or paper-based processes to manage CAPA and remediation processes is ineffective as they fail to address systemic problems due to a lack of broad enterprise reach and visibility. To successfully develop and implement...
Effective risk management and compliance with government regulations drive the need for ongoing auditing in organizations. For companies that are regulated by the FDA or are following quality standards such as ISO 9000/14000, regular audits are also essential to reduce the risk of noncompliance. With increasing business complexity and the rising number and types of audits that companies need to conduct, companies are realizing that...
Employee training forms a key part of quality control as well as governance, risk and compliance programs for all companies, big or small. For companies whose operations require compliance with federal regulation such as FDA and OSHA or are following quality standards such as ISO 9000/14000, streamlined regulatory compliance training procedures and ability to monitor the effectiveness of training are essential to reducing the risk of ...
Effective equipment and equipment facilities management is essential to ensuring constant uptime and to control maintenance costs. For companies that are regulated by the FDA or are following quality standards such as ISO 9000/14000, accurate calibration and general maintenance of equipment is a critical factor for meeting established quality requirements for product and processes quality and reducing the risk of noncompliance.