Quality Management needs to Integrate with Business Systems
Information technology has armed today’s customers with extensive information on vendors and ready access to competitive products. These customers can assess and compare more than the initial price of a product when determining the cost of ownership with the click of a mouse or an “app” on their smart phones or tablets. By tracking costs
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When to Initiate a CAPA Plan
The CAPA process must be linked into every other part of the Quality System (QS). This means that there must be process and work flows to and from CAPA process and each element of the QS. These document management work flow and processes shuttle quality data and information to CAPA process (and then on to
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Computerized Systems and Software Validation
Computerized Systems or Software that perform GxP related functions in the Life Science industry must be qualified or validated. Business Intelligence Solutions is presenting a webinar on Risk Based Computerized System Validaiton on September 27. Validation of Computerized Systems and Equipment ensures that a computerized system or equipment is appropriate for its intended use. A
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The Essential Components of a Sound Regulatory Strategy
In today’s competitive pharmaceutical and biotech market, the success of any new product depends on how well a company integrates a well-conceived strategic product development plan with the essential components of a sound regulatory strategy. What are the essential components of a sound regulatory strategy? Conduct of a regulatory review of available product data, including
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