Database security project proposal
Global data Integrity violation examples
ABSTRACT:
Global Data Integrity is important to understand what data integrity really means in order to be compliant. Data integrity refers to the fact that data must be reliable and accurate over its entire lifecycle. Data integrity and data security go hand in hand, even though they’re separate concepts. Uncorrupted data (integrity) is considered to be whole and then stay unchanged relative to that complete state. Nowadays, Data integrity is mandatory for the regulated healthcare 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. Drug, medical device manufacturers, service providers, health authorities, end users and administrators of the product (patients and healthcare professionals) rely on robust traceable data.
Data integrity issues pose such a high risk and are not always easily detectable. As electronic data recording and management systems are implemented instead of paper systems, the detectability of data manipulation becomes more complex. Certain controls and requirements should be validated to mitigate any risk for data to be manipulated electronically. In addition, verification of audit trails in electronic management systems, training of operators and staff to promote cGMP awareness, along with the ramifications of breaching data integrity when recording results is critical.
When there is violation of data integrity there is impact on the organization as whole if financial data is violated or data of product that is to be launched is compromised and some one violates the global data integrity then there are chances that the competitor may implement that product before the organization.
Study will be focused on these areas:
Understand what Global Data Integrity Is? What laws are made to protect data integrity?
Study examples where the integrity is compromised. Each example will be studied with the reason for compromise and actions taken for volition of data integrity.
Some common steps that can be taken by organization to prevent violation of data integrity.
REFRENCES:
1. Data Integrity and its mitigation.
https://www.globalvisioninc.com/blog/12-ways-to-reduce-data-integrity-risk/
the article provides the importance of data integrity and explains the factors that can reduce the risk of compromising data integrity.
Article makes us aware of how important it is to ensure your data is not compromised. The impact of dangerous data can have resounding consequences on any organization no matter the size. However, if data integrity is thought of as a process, the data infrastructure can become an asset instead of a liability.
2. Data Integrity Issues: Causes and Solutions
This article summarizes the message for data integrity is clear, it’s about getting back to the roots of training all staff on the importance of data integrity in cGMP documentation and honesty. It is critical to ensure employees understand the accountability and traceability requirements for retention of raw data and the consequences of data manipulation.
This article shows down all the causes and technicality of the issues in data integrity. It provides the details on the ethics that needs to be maintained for prevention of violation of data integrity.
3. MHRA GxP Data Integrity Definitions and Guidance for Industry
https://www.gov.uk/government/news/mhra-gxp-data-integrity-definitions-and-guidance-for-industry
This consultation document provides guidance on the data integrity expectations that should be considered by organizations involved in any aspect of the pharmaceutical lifecycle or GLP studies regulated by MHRA.
Since there is huge risk in pharmaceutical industries for the compromise of data integrity the document provides information on the compliances that should be made for protecting the data integrity.
4. FDA Chides Two More Indian Drug Manufacturers for Potential Testing Fraud
https://www.fda.gov/downloads/drugs/guidances/ucm495891.pdf
The inspection of FDA identified numerous examples of ‘trial’ injections for various drug products (U.S. and non-U.S. markets), which suggests that this is a common practice.
5. Ernst & Young, Analyzing the State of Data Integrity Compliance in the Indian Pharmaceutical Industry (June 2015), accessed 1 Apr. 2016.
https://www.ey.com/Publication/vwLUAssets/ey-analyzing-the-state-of-data-integrity-compliance-in-the-indian-pharmaceutical-industry/$FILE/ey-analyzing-the-state-of-data-integrity-compliance-in-the-indian-pharmaceutical-industry.pdf
This report is based on the responses received from over 170
respondents from the Pharmaceutical Industry in India during the
period January–March 2015. The principal respondents were from
Business Management, Corporate quality, and Legal and Compliance
domains. They represented a mix of active pharmaceutical ingredients,
formulations excipients and others supplying domestically as well as
exporting to countries such as the USA, Europe, Japan, Australia, etc.
Most regulatory bodies such as the US FDA, the UK MHRA, the India FDA and others
conduct inspections on pharmaceutical manufacturing sites or facilities to check if they
comply with the defined GMP standards. Country needs to be taking steps for vigorous inspections to follow with the regulations.