Pharmaceutical experts release new guide to good practice
The International Society for Pharmaceutical Engineering (ISPE), headquartered in North Bethesda, recently released a new guide entitled ISPE GAMP® RDI Good Practice Guide: Data Integrity – Key Concepts, which details ways to keep data secure in specific organizations.
John Bournas, ISPE's president and CEO, notes that recently, the medical device, biotechnology, and pharmaceutical industries have had problems keeping data safe worldwide. If unreliable data is then used to determine decisions about regulations, patient safety may be at risk. Bournas says the new guide integrates critical thinking and cultural excellence into data integrity, in order to help companies meet the requirements of their regulatory agencies.
The new guide goes along with ISPE GAMP® 5: A Risk-Based Approach to Compliant GxP Computerized Systems. The abbreviation GxP”= is understood as ‘good practices’, and refers to industries that are regulated by agencies such as the U.S. Food and Drug Administration (FDA) or the World Health Organization (WHO), for example.
The new publication provides detailed guidance in four basic areas: critical thinking, risk management approaches, data lifecycle, and data governance. Organizations such as this, which provide detailed publications on specific subjects, could work further with a flyer printing organization to create a summary of the guide for people to study before purchase.
The ISPE will present its new guide in Philadelphia at its annual meeting, which is scheduled from this Sunday, November 4, through Wednesday, November 7.
John Bournas, ISPE's president and CEO, notes that recently, the medical device, biotechnology, and pharmaceutical industries have had problems keeping data safe worldwide. If unreliable data is then used to determine decisions about regulations, patient safety may be at risk. Bournas says the new guide integrates critical thinking and cultural excellence into data integrity, in order to help companies meet the requirements of their regulatory agencies.
The new guide goes along with ISPE GAMP® 5: A Risk-Based Approach to Compliant GxP Computerized Systems. The abbreviation GxP”= is understood as ‘good practices’, and refers to industries that are regulated by agencies such as the U.S. Food and Drug Administration (FDA) or the World Health Organization (WHO), for example.
The new publication provides detailed guidance in four basic areas: critical thinking, risk management approaches, data lifecycle, and data governance. Organizations such as this, which provide detailed publications on specific subjects, could work further with a flyer printing organization to create a summary of the guide for people to study before purchase.
The ISPE will present its new guide in Philadelphia at its annual meeting, which is scheduled from this Sunday, November 4, through Wednesday, November 7.