Basics of Data and Data Integrity - Very Very Important - Pharma Times Now - Pharmaceutical Industry and Regulatory Affairs

The amazing modern world is now moving on the wheels of 'data'. Data integrity is like a green flag which allows the journey of the digital world into a secured future. Today, every individual's life is linked with the technology. Similarly, every industry that running today has been built on the foundation of technology only. Undoubtedly digital data is the fuel of all industries. But the Cyber attacks are the biggest threat to the electronic data.

It's not an overstatement if I say, "There is no single field on the planet, which is not influenced by information technology".

At present, computer technology is governing everything. It has stepped into every nook and corner of our life. It became a driving force of human life.

All industries are using the software in manufacturing activities to reduce the production time as well as to increase the accuracy in manufacturing processes.

The software is a set of instructions that guide a computer to do a specific job. A lot of data will generate while executing the designated work.

The data generated during the execution of a work is the source of our analytics. This lets you understand the quality of work being done.

By using a validated software, you can easily identify whether a work is carried out in a right method or not.

Introduction Of Data

Data is a set of details about a work that carried out in a certain environment to accomplish a specific task. Every work in the universe has six dimensions to indicate its existence. They are time, place, process, initiation, duration and output. Data reflects these six dimensions in a sequence.

Time

Every work starts and ends at a certain point on a timescale.
Example: Starting time: 10:15 A.M

Place

This dimension indicates the location where the work is carried out.
Example: Plant-1; Industrial Area; Hyderabad.

Process

It defines the method in what way work to be progressed and the steps involved in it.
Example: A procedure to prepare an apple juice; A chemical formula to manufacture a soap.

Initiation

A certain thing is required to conduct the work or bring a motion in the activity until its completion. It may be either a man or a machine.

Duration

A work starts and ends at a definite point on time scale. This length of time taken to finish it is called the duration. Example: A chemical reaction's lead time could be 15 hours.

Output

This indicates the final result of the activity.
Example: An apple juice; a soap

All the details generating through the above six dimensions are called a data. Data is nothing but a collection of the whole events in detail. If you write all these events on a paper, it is a paper record; if you write them in an electronic form, then it is an electronic record. Data has a broad meaning, especially in computer field.

What Is the Meaning Of Data In Computer Technology?

A software may be used to carry out a work which records the information or events in a chronological order. The collection of all these events are called "data" or "electronic data". It has a certain size measured in bytes. The data available in an electronic form is also referred to as an electronic record.

The information, about an "activity", converts into a binary form (a bunch of ones and zeros) which is called "raw data" and it is stored on a computer's hard disk. In other words, raw data is the basic digital format of an information.

This raw data is further processed and converted into a human readable form with the help of a computer. The Computer employs a software to convert the distinct pieces of the information into a predefined human-readable format.

Software usually consists of two parts. 1. Data 2. Programs

Programs are the collection of coded instructions which perform a given task automatically and serve in handling the data. Here data means it includes text, graphs, images, audio and video. It can be stored in different file formats.

Types of Electronic Data

Based on the type of arrangement, data can be categorized into structured and unstructured data.

Structured data

In this category, data is stored and organized in a certain pattern which makes the search easy. The speed of information recall is higher with structured data.

Relational databases (RDBMS) generally store the data in a structured way in rows and columns. In these types of databases, data may be generated by a machine or human beings. It is searchable with just field names or simple queries.

Examples of structured data are data on bank services, inventory controls in manufacturing companies, chromatography data in laboratories, airlines reservations etc.

Unstructured data

This is quite opposite to structured data. In this category, different types of data are stored as a dump in an unorganized way.

Data such as images, PDFs, emails, text data are not stored in the predefined model or format. Due to this reason, data mining in an unstructured data pool is very expensive.

Some examples are emails, Facebook, YouTube, SMS in mobiles, MS office documents on a personal computer.

What is metadata?

It is data about the data. Confused??? Here is the simplest way to deal with it. Metadata is nothing but a bundle of details about the other data. For example, there is an image. The image is also electronic data. The details of the image such as date of creation, created by and description, would fall under Metadata. It is a contextual information and helps in understanding the data.

Characteristics Of Electronic Data

Data exists in a certain form and quantity.

Since it has some form, it is convertible into other forms.
Since it has some quantity, it is movable across different media.

The main characteristics of electronic data are:

Tools For Generating And Handling Of The Data

In any field, we use Software to generate and handle the data. The software allows us to complete a task(s) and stores the data electronically. It also converts the data into human-readable formats. The software is a set of instructions which directs the computer how to handle and present the data.

There are two types of software: 1. System Software 2. Application Software

System Software

This works on the computer itself and manages the hardware. Usually, we call system software as an ''Operating System''. It enables the interaction between user and hardware.

The well-known Operating Systems are "Windows" from Microsoft and "Linux" which was developed by Linus Benedict Torvald.

Application Software

These are the programs designed to complete a task. A simple application software we see in our general life is on the calculator. Application software enables the user to complete a task and evaluate the output of the data. This type of software boosts productivity.

MS Word, MS Excel, Chrome, Firefox, SAP applications, Software in ATMs and website applications are some examples of application software to quote.

The software is the primary tool in the whole process of data generation and handling.

What Is Data Integrity?

It mainly refers to the completeness, consistency, and accuracy of the data. The data which maintains its integrity is reliable and trustworthy.

Data should remain intact and self-consistent throughout its life-cycle, even while transferring and storing it on different media. It means the original data should be available over its entire life cycle without corruption or lose.

Data should be error-free even while retrieving it from storage media. It should not lose its accuracy and should be consistent, i.e., it must produce the same output in the same manner over time.

Data must be attributable and should not give scope to any kind of alterations. It should not miss any of its components from its original mass while handling it for various practical purposes. It means completeness and originality at all times and situations should be the inherent characteristics of the data.

Data integrity is questionable when it fails to maintain its originality while transfer, storage, process and retrieval activities performed. The degree of accuracy and consistency reduces when data integrity is compromised. Data must be auditable at all times in its life cycle.

Possibilities For The Breach of Data Integrity

Breach of data integrity may occur due to the intentional or unintentional acts of people, malicious programs and programming errors. These activities may find their ways into organizations either by their internal employees or external persons such as hackers. Some possible ways of a data breach are listed below.

1. Cyber attacks due to the lack of proper security systems.

2. Alteration of data by unauthorized personnel.

3. A poor access control system of data.

4. Accidental changes or deletion of data.

5. Data corruption during the transit to other media.

6. Change to data due to electromagnetic pulse (EMP) or server crash.

7. Data loss or corruption due to disasters such as fire accidents, cyclones and earthquakes.

8. The ability of hackers to modify or delete data due to poor internet security systems.

9. Unawareness of employees on how to use Email system in a secured way.

10. Presence of malware in the computerized systems that allow remote access of the data.
11. Improper backup or irregular backup of data.

12. Use of unencrypted data via networking systems.

13. Data corruption due to programming errors.

14. Human errors while entering the data

15. Intentional wrong inputs into the software.

16. Data corruption by bugs and viruses in software.

17. Malfunctions in hardware may generate erroneous data

18. Power fluctuations can corrupt the programs

19. Software design flaws can give scope to unauthorized changes in the data.

20. Errors in data transmission can lead to incomplete data transfer.

How To Manage The Data?

Data is the most important thing for any organization, whether it is in the private or public sector. It is the foundation for any business in modern society. Hence, data management is a critical part and requires a lot of safety and security measures.

Technology is a knife with two sharpened edges. You will be benefited if you utilize it in the right way. Otherwise, if it goes into the hands of evil-minded people such as hackers, the amount of harm going to come about is unpredictable. Therefore data management has a lot of significance in the digital world.

Precise safety measures have to be designed to protect the data integrity. Cyber threats from internal and external people, throwing a major challenge to all kinds of industries.

The following are some approaches to prevent the breach of data integrity.

1. Use validated software only at all times and all phases, to ensure uncorrupted data transmission.

2. Encrypt the data when you are using networking systems for your transactions.

3. Clearly define the scope, role and responsibilities of the employees who are dealing with the data.

4. Establish disaster management systems to prevent the unexpected loss or corruption of data.

5. Install security systems to withstand cyber threats. Hackers will try in many ways to take control of your computer systems from remote areas.

6. Use secured Email system and train all your employees on the probabilities of cyber attacks via phishing emails. Many malware and trojans can easily enter into your systems via email attachments.

7. Create at least one strong hierarchy level of the person who is responsible for critical operations, to prevent accidental or intentional publishing of confidential data.

8. Users should have unique login credentials, to enter into the computerized systems and relevant software, to ensure the accountability.

9. Take the backup of data and store in an alternate location. It is suggested to take at least two copies of the data and store each one at a different place as a safety measure.

Make a schedule for the data backup and define the period when to take it, i.e., daily, weekly or monthly. Check the activity time to time and verify the integrity of the data periodically. If you have any observation, record it and investigate. Take appropriate measurements to mitigate the problem.

10. Design user interface in such a way that it can prevent the input of invalid data. Take Date Field as an example. In this field, only numbers have to be entered by the user. In case he tries to use the alphabet, the software should give an alert immediately and prevent him from entering the data.

11. Use error detection and correction programs to prevent loss of data at the time of data transmission.

12. Track user's activity by using audit trail program and control the unethical behaviour of bad guys, if you have any. The audit trail is a program which records the activity of users in chronological order. It records the details like who, what, when, and why of a transaction/record.

If you follow the above-said approaches, your data will come into a safe zone and stays away from corruption and unauthorized modification. These steps assure the integrity of the data. Always maintain accurate, complete and consistent data in the organization.

Summary

Computer technology and electronic data are the backbones of any kind of industry on the globe. Technology has penetrated into our very lives so deeply such that its influence in our lives is unavoidable. In fact, it is dictating our lives. This is the very reason for the worry of the integrity of data.

Data is generated with the help of software. This can be categorized into structured and unstructured data.

All relational databases come under structured data. Rest of all falls under the category of unstructured data.

Data can be processed, modified, transferred, stored and retrieved.

Data integrity is reliable when your data is accessible, accurate, consistent and complete even while transferred, stored and retrieved.

A data breach can occur in various ways. Cyber attacks, non-validated software, uncontrolled user activities, bugs and viruses, malware and trojans, unencrypted transactions and programming errors are some of the main reasons for the breaches of the electronic data.

The integrity of the data can be protected by taking various security measures such as the installation of effective antivirus software, defining the disaster management, periodical backup of the data and monitoring the user activity through audit trail.

Your data is reliable as long as it is auditable at any point of time in its Lifecycle.

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Author Profile

Ram Kumar Reddy

Ram Kumar Reddy is the founder of Pharma Times Now. Helping students of Pharmacy and Chemistry and employees in the pharma industry in learning pharmaceutical science. Ram Kumar Reddy has 24 years rich experience in the Pharmaceutical industry and well versed in quality systems. He worked with Dr.Reddys and Sai Life Sciences. He lives in Hyderabad, India.