National AIDS Research Institute [NARI] was established in October 1992 in Bhosari, Pune on a seven acre plot. The Institute has progressively expanded its activities in various aspects of research on HIV and AIDS through infra-structural development, capacity building & research programmes. The present infrastructure includes the Institute housed in a 28024 sq. mtr space, residential accomadation for the staff, a power plant to ensure uninterrupted power supply and an incinerator for safe disposal of bio-waste.
Founded in 1849, Pfizer is the world's premier biopharmaceutical company taking new approaches to better health. We discover, develop, manufacture and deliver quality, safe and effective prescription medicines to treat and help prevent disease for both people and animals. We also partner with healthcare providers, governments and local communities around the world to expand access to our medicines and to provide better quality health care and health system support. At Pfizer, colleagues in more than 90 countries work every day to help people stay happier and healthier longer and to reduce the human and economic burden of disease worldwide.
ABOUT AUTHORS Rohit A. Patil1*, Shruti N.Patil2 Department of Regulatory Affairs,
Supreme Pharma Healthcare Pvt. Ltd. Mumbai, MH, India * rohitpharma3250@gmail.com
ABSTRACT
Good storage of data & record management are critical elements of pharmaceutical quality system. Data integrity refers to maintaining & assuring the accuracy & consistency of data over its entire life –cycle in compliance with its applicable regulatory requirements.
Data integrity is mandatory for the regulated pharmaceutical industry, as processing and disposition decisions regarding product quality, safety, efficacy, purity, and compliance with the applicable regulatory requirements are made based on data that is recorded and reported. Data integrity risk should be assessed, mitigated, communicated & reviewed throughout the data life cycle. Healthcare industries should be designed Record-keeping methodologies and systems, in a way that encourages compliance and assures data quality and reliability.
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