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With thousands of regulations being released yearly, global regulatory compliance can be costly and cumbersome. Cognizant has a strong track record in helping companies manage compliance issues. Knowing that success requires a holistic, digital approach, our operating model helps you comply with industry standards. Our best practices focus on information security management, FDA guidelines on system validation, and electronic records and signatures.
Partner with Cognizant and our global team of industry and digital technology experts for help with independent validation services, regulatory application development and specialized consulting services.
We assist with regulated and critical business processes, such as submissions management, labeling, digital asset management, pharmacovigilance case processing, clinical data management and analytics.
Assures the necessary validation of computer systems’ compliance in optimal time and cost.
Our services are fully compliant with 21 CFR 11 (the FDA’s guidelines for electronic record-keeping by pharmaceutical companies) and other pertinent standards, such as ISO 9001, ISO 13485, ISO 14971, SEI-CMMI, BS7799 and CSV. Many services leverage newer digital technologies, such as the cloud, data analytics, mobility and social media. These help clients quickly adapt to changing business conditions with increased agility, scalability and efficiency.
Includes the evaluation of off-the-shelf products for Part 11 compliance, working with the Submission Process Re-engineering framework and evaluating the impact of global regulatory updates on corporate processes and systems.
Staffed with certified consultants on regulatory affairs and consultants with documented industry experience, ORAC takes accountability for compliance in Cognizant’s engagements and provides thought leadership to the industry.
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