It is critical for every regulated company to comply with data integrity and product quality requirements set by the FDA. It isusually called cost of effective validation. It involves a reduced number of 483s and most importantly existence of the product in the market too.
These days, enhanced product quality needs, technological considerations and a controlled cost of production spur medical and pharmaceutical companies to adopt a multi-site development model. Being a highly regulated industry, it raises a lot of questions on data security and integrity. The overall product development and operations model involves USFDA and other regional regulatory compliance. It is a huge cost to govern and maintain all SOPs involved during this process.
It becomes a major challenge for all medical device and pharma companies to consolidate Computer System Validation SOPs. A focus on integration, optimization and standardization of Computer System Validation Processes across the globe is required to achieve a high standard regulatory compliance. This is required to succeed in the current challenging and market scenario.
