CSV Best Practice

Data Integrity App Data integrity can be compromised through human error or, worse yet, through malicious acts. Data that’s accidentally altered during the transfer from one device to another, for example, can be compromised, or even destroyed by hackers. Common threats that can alter the state of data integrity include: Human error Unintended transfer errors Misconfigurations and security errors Malware, insider threats, and cyber attacks Compromised hardware So how do you know when your data has integrity? You have to look at the following features: Retrieve ability and accessibility – It’s important to have accurate data in the proper locations at the right time when anyone is working on projections, a deal, or presentation. Without proper and easy access and retrieval, it can be detrimental to the business, yielding the way for your competition to win. Traceability – Today, you can trace every touchpoint you make with a prospect or customer. H

Data Integrity App The data integrity threats listed above also highlight an aspect of data security that can help preserve data integrity. Use the following checklist to preserve data integrity and minimize risk for your organization: Validate Input:  When your data set is supplied by a known or unknown source (an end-user, another application, a malicious user, or any number of other sources) you should require input validation. That data should be verified and validated to ensure that the input is accurate. Validate Data:  It’s critical to certify that your data processes haven’t been corrupted. Identify specifications and key attributes that are important to your organization before you validate the data. Remove Duplicate Data:  Sensitive data from a secure database can easily find a home on a document, spreadsheet, email, or in shared folders where employees without proper access can see it. It’s prudent to clean up stray d

Data Integrity App   What is data integrity? It 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.   Maintaining or keeping data consistent  throughout its lifecycle  is a matter of protecting it (security) so that it’s reliable. And data that’s reliable is simply able to meet certain standards, with which compliance is necessary.   For example, the FDA uses the acronym ALCOA to define data integrity standards and to relate to good manufacturing practices. Data is expected to be: 1.          Attributable – Data should clearly demonstrate who observed and recorded it, when it was observed and recorded, and who it is about. 2.        

  Data Integrity App A designated secure area or facility (e.g. cabinet, room, building or computerized system) for the long term, permanent retention of complete data and relevant metadata in its final form for the purposes of reconstruction of the process or activity.   All over the pharmaceutical industry, both businesses and patients depend heavily on the integrity and confidentiality of archived records. In the highly regulated world of drug manufacturers, properly preserving documentation is a critical requirement for business continuity. Archived records may be the original record or a ‘true copy’ and should be protected so they cannot be altered or deleted without detection and protected against any accidental damage such as fire or pest.     Archive arrangements must be designed to permit recovery and readability of the data and metadata throughout the required retention period.  In the case of archiving of electronic data, this process should be validated, and in the case of

Data Integrity App   What is a Vendor Agreement? A vendor agreement is a legal document that states the stipulation of the work to be performed by a contractor for your business. It sets the provisions regarding the type and quality of services to be provided, duration, cost, liability, etc. of the vendor’s services Understanding the Vendor Contract A contract is an agreement between two parties creating a legal obligation for your organization and vendor to perform specific acts. Each of the parties to the contract are legally bound to perform the specified duties outlined within the contract.      From a regulatory perspective, organizations must have a formal contract with vendors that provide services. The contract must clearly address the duties and responsibilities of the parties involved.   In the past, some institutions may have had informal expectations for vendors that were not committed to writing or not adequately reviewed and, therefore, created issues with enforceability