Competitive global markets, more-demanding patients, regulations from multiple regulatory authorities and high product development costs are forcing life sciences companies to deliver high quality products at low costs. Conformance to stringent requirements of global regulatory bodies is highly challenging. There is always an inherent product related and process related risks in any business process models. There is a need for compliance at every stage of product development life cycle that has high relevance in reducing the inherent product and process related risks. Non-compliance may affect the business adversely, leading to loss of market and reputation. Integrating the business process with the regulatory requirements has been the solution adopted by the companies to address the compliance requirements and the risk management. The regulatory bodies continue to raise the bar regarding the scope of compliance efforts required to manage the risks inherent in Product life cycle.
At every phase of the product life cycle, from R&D through manufacturing, distribution and marketing of products, life sciences companies must adhere to regulations from local, national and international authorities. Perhaps the most challenging element of mitigating compliance risk throughout the life cycle is ensuring compliance controls are appropriately integrated across the functional areas. Read more to know how HCL can simplify GRC for life sciences.