Change Control-Implementation and Management
Duration: 1 Hour
FDA Warning Letters and recent high profile recalls indicate major cGMP deficiencies in many companies. One major failing is insufficient, poor, or even lack of meaningful change control. The traditional paper-based, manual and ad-hoc approach to change management is error prone, unreliable and ultimately unsustainable. An enterprise wide change management solution is a key requirement for managing and controlling change for operational excellence as well as for regulatory compliance.
MetricStream Change Management software enables organizations to follow a structured methodology for each change request and track it through its lifecycle from initiation through verification to closure. It ensures that documentation reviewed years later correctly reflects how product was designed, produced, tested, and released years earlier. Essential to prove a company's due diligence, and minimize liability. Without change control, there is no quality system. It also ensures that the change is disseminated to all concerned entities and leads to the intended outcome. When used in conjunction with quality processes for CAPA, Document Management, Training, etc., change management and control can be a powerful tool for continuous improvement in the organization.
Panelist(s) Info:
Ed Park - Director of Sales
Raghuraj Gaikwad - Manager Sales - FDA Compliance
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