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Introduction In the pharmaceutical industry, Out-of-Specification (OOS) events can have significant consequences, impacting product quality, patient safety, and regulatory compliance. Effective OOS investigation is crucial to identify the root causes, implement corrective actions, and prevent future occurrences. This blog post will explore various tools and techniques employed in OOS investigations. Essential Tools for OOS Investigations Data Analysis Tools: Statistical Software: Leverage software like Minitab, Excel, or specialized statistical packages for data analysis, trend identification, outlier detection, and process variability assessment. Quality Management Systems (QMS): Utilize QMS software to centralize and manage quality data, facilitating efficient data retrieval, analysis, and reporting during investigations. Electronic Batch Records (EBR): Employ EBR systems to capture and store detailed manufacturing process information, aiding in tracing back steps, identifyi...

Biometric Devices | It's Use In Pharmaceutical Company

Biometric Device and its Use In The Pharmaceutical Industry

Biometric Devices | It's Use In Pharmaceutical Company

In the Pharmaceutical industry, accuracy is too important. As the pharmaceutical company deals with patient safety, more focus is given to product quality. To meet the quality standards, regulatory requirements nowadays pharmaceutical companies are biometric devices not only for attendance but for access control and many more.

Before going deep into biometric devices and their use, we must understand what is a biometric device. A biometric device is a system that stores and measures our physical identity and when shown, it verifies or compares the stored identity and provides us access to the system. 

It is a computerized system. Made up of both hardware and software components.

Biometric devices include retina scanners, fingerprint scanners, and face scanners in which the system scans the authorized entry against the specimen stored in the system.

Nowadays, everywhere fingerprint scanners are being used. For smartphones also all brands have developed fingerprint and face scanners. 

However, in the pharmaceutical industry, the usage of biometric devices is more. Due to the biometric devices, many activities' time duration is shortened, and more accurate data is produced. The most reliable and accurate data is produced by the biometric device. 

How Biometric Device Works?

There are four steps of a biometric system operation −

  • 1. Live sample collection from candidates. (using sensors)
  • 2. Extract matrix / prominent features from the sample and storage of the sample is a database as identity. (using processing unit)
  • 3. Compare live samples with samples stored in a database. (using algorithms)
  • 4. Present the decision. (Accept or reject the candidate on verification.)

The biometric sample is acquired from the candidate user. The prominent features are extracted from the sample and it is then compared with all the samples stored in the database. When the input sample matches with one of the samples in the database, the biometric system allows the person to access the resources; otherwise prohibits.

Biometric Devices | It's Use In Pharmaceutical Company
How biometric device works?

Reference: 
https://www.tutorialspoint.com/biometrics/biometrics_overview.htm

Biometric Devices | It's Use In Pharmaceutical Company
Biometric Device Operation - How retina scanner works?

Reference:https://www.starlinkindia.com/blog/biometrics-face-recognition/

Evolution of Biometric Devices:

In the 19th century, an Anthropologist named Alphonse Bertillon developed a method (named Bertillionage) of taking body measurements of persons to identify them. He had realized that even if some features of the human body are changed, such as length of hair, weight, etc., some physical traits of the body remain unchanged, such as the length of fingers. This method diminished quickly as it was found that the persons with the same body measurements alone can be falsely taken as one. Subsequently, Richard Edward Henry from Scotland Yard developed a method for fingerprinting.

The idea of retinal identification was conceived by Dr. Carleton Simon and Dr. Isadore Goldstein in 1935. In 1976, a research and development effort was put in at EyeDentify Inc. The first commercial retina scanning system was made available in 1981.

Iris recognition was invented by John Daugman in 1993 at Cambridge University.

In 2001, Biometrics Automated Toolset (BAT) was introduced in Kosovo, which provided a concrete identification means.

Today, biometrics has come up as an independent field of study with precise technologies for establishing personal identities.

Usage of Biometric Devices In Pharma?

  • Attendance system
  • Access control system 
  • Entry barrier
  • Password control system
  • For 
  • For authorized and authenticate usage
  • For data storage and access
  • Identify and verify a person.
  • Authenticate a person to give appropriate rights to system operations.
  • Keep the system safe from unethical handling.

Another usage of biometric devices:

  • Password control
  • For authorized entry
  • For authorized locker access's
  • For login/log out
  • For final certification
  • For criminal findings
  • Controlling workplace access.
  • Identity establishment of people for authentic citizenship and immigration systems.
  • Applying access control to sensitive information and systems.
  • Identifying criminals by forensics.
  • Executing online e-commerce transactions.
  • Fraud and theft reduction.
  • Law enforcement.

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Benefits of Usage of Biometric Devices:

The use of biometric devices has given us tremendous benefits. 

Always many persons use to forget their passwords, but due to biometric devices, the password reset process time is reduced. For the systems which have another administrator, the password reset process is very time-consuming. 

We can use it for the attendance system. This is the biggest benefit wherein we can actual entry/exit of the person from the area. This has reduced many documentation procedures 

As the biometric device scans our own specimen copy of physical identity, the system is reliable and will give consistent and accurate information in the auditing process.

Instead of a lock n key, we can use a biometric device. This will increase security.

Where to Install the Biometric Devices in pharma company?

In pharma company biometric devices can be installed at below;
  • At entry for attendance system.
  • To critical area entry for entry/exit authorization
  • On the equipment and software panels to have system access.

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