Question

Who is responsible for the computer system data and the integrity of that data in a computer system?

Answer 1

Answer:

Data integrity is the maintenance of, and the assurance of the accuracy and consistency of, data over its entire life-cycle, and is a critical aspect to the design, implementation and usage of any system which stores, processes, or retrieves data. The term is broad in scope and may have widely different meanings depending on the specific context – even under the same general umbrella of computing. It is at times used as a proxy term for data quality, while data validation is a pre-requisite for data integrity. Data integrity is the opposite of data corruption. The overall intent of any data integrity technique is the same: ensure data is recorded exactly as intended (such as a database correctly rejecting mutually exclusive possibilities,) and upon later retrieval, ensure the data is the same as it was when it was originally recorded. In short, data integrity aims to prevent unintentional changes to information. Data integrity is not to be confused with data security, the discipline of protecting data from unauthorized parties.

Any unintended changes to data as the result of a storage, retrieval or processing operation, including malicious intent, unexpected hardware failure, and human error, is failure of data integrity. If the changes are the result of unauthorized access, it may also be a failure of data security. Depending on the data involved this could manifest itself as benign as a single pixel in an image appearing a different color than was originally recorded, to the loss of vacation pictures or a business-critical database, to even catastrophic loss of human life in a life-critical system.

Methods

Perform Risk-Based Validation

Select Appropriate System and Service Providers

Audit your Audit Trails

Change Control

Qualify IT & Validate Systems

Plan for Business Continuity

Archive Regularly

Secure your records with limited system access

Maintain backup and recovery procedures

Answer 2

Answer:

computer system data and the integrity

Explanation:

statistics integrity in CSV audits is one in every of the biggest reasons for non-compliance and thanks to which warning letters/483s, heavy quality, ban on products, and so forth. are issued to organizations.

US FDA’s definition to keep away from information integrity troubles are:

ALCOA (C)

• Attributable: the information have to be attributed to a specific user; Who obtained the information and whilst
• Legible: the info of which have to be loud and clean; are you able to read the information (e.g., handwriting, durable ink)
• Contemporaneous: nothing may be accomplished in hindsight, and date & time of seize is critical; Are information document at the time of statement
• original: the informtion of which might be as received; Are statistics offered similar to in the beginning recorded
• accurate: proudly owning to the accuracy of the data acquired; Are presented take a look at result what's in the take a look at pattern
• whole: all the details to be captured and recorded; Does the report encompass everything as required by policies

owing to ALCOA(C), the observations are usually:

• Failure to preserve complete statistics (lab exams, even uncooked facts, etc.)
• Failure to seize records on the very time when the activities had been executed
• Failure to file failed instances
• modifications in data without them getting recorded inside the gadget
• Incomplete or uncertain records/facts
• Backdating the information
• Non-conclusive, incomplete, erroneous statistics seize

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