Consolidation of Computer System Validation SOPs

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.