With the advent of global competition, maintaining quality standards has become increasingly important for companies in these industries. As a result, many biotechnology and pharmaceutical companies are turning to electronic quality management software (eQMS) solutions to automate their quality control processes to meet these standards.  

This blog will explore the different features and benefits of eQMS software, how it can help businesses reach their desired level of excellence, and how PSC software can help with our industry-leading eQMS software.     

What is a Quality Management Software?   

An eQMS is a tool that allows companies to manage and monitor their quality operations in an efficient centralized manner. When applied to the product life cycle, an eQMS helps drive the quality of the product through ideation, development, prototyping, production, and distribution. This is accomplished through specific software modules for prototyping, development, file tracking, employee training, quality event management, supplier management, and more.

With a quality management system in place, businesses better adhere to their processes while identifying inefficiencies and areas that need improvement.  

Validation is vital for pharmaceutical or life science manufacturers because it ensures that the equipment used in the manufacturing process can consistently produce high-quality products. It also provides the safety and effectiveness of the medications they produce, helps them comply with regulatory requirements, and can improve the efficiency and productivity of their operations. 

This is important for several reasons.  

  • First, accurate and reliable equipment is necessary to produce safe and effective medications for patients. If the equipment is not adequately validated, there is a risk that the medications produced using it may not be of the required quality, which could put patients at risk. 
  • Second, equipment validation is essential because it helps pharmaceutical manufacturers comply with regulatory requirements. Many countries have strict laws and regulations governing the production of pharmaceutical products. These laws often require manufacturers to validate the equipment they use to ensure that they can consistently produce high-quality products. By properly validating their equipment, pharmaceutical manufacturers can demonstrate to regulators that they are following the necessary quality controls and operating in compliance with the law.
  • Lastly, equipment validation is vital for pharmaceutical manufacturers because it can help improve the efficiency and productivity of their operations. Properly validated equipment is more likely to operate at optimal levels, which can help manufacturers produce more products in a given amount of time. In addition, validated equipment usually follows a preventative maintenance program and is thus less likely to break down or malfunction, which can help reduce downtime and keep the manufacturing process running smoothly. 

Manufacturing and laboratory equipment validations are critical processes that ensure the safetyfunctionality, and quality of manufactured goods and analytical equipment. Manufacturers must ensure that their products meet the required quality and safety standards and perform as expected. This is especially important for products used in the medical and scientific fields, where accuracy and reliability are crucial. By performing validations, manufacturers can ensure that their products meet customer expectations and are safe for use.

What is the process? 

There are several steps involved in the validation process for manufacturing and laboratory equipment, which typically include the following: 

  1. Planning: The first step in the validation process is to plan out the validation process, including identifying the equipment to be validated, the objectives of the validation, and the methods and criteria used to evaluate the equipment. Refer to your Validation Master Plan (VMP) for planning, which our consultants can develop for you. 
  2. Installation Qualification (IQ): This step involves verifying that the equipment has been installed correctly and is operating according to the manufacturer’s specifications. 
  3. Operational Qualification (OQ): This step involves testing the equipment to ensure it can perform its intended functions consistently and accurately. 
  4. Performance Qualification (PQ): This step involves testing to verify that the equipment can produce products that meet the required quality standards. 
  5. Ongoing monitoring and maintenance: Once the equipment has been validated, it is important to monitor it regularly to ensure that it continues to operate correctly and produce reliable results. This may include regular calibration and maintenance of the equipment. 

Difference between Validation and Calibration

When assessing the accuracy and reliability of measurement systems, the terms validation and calibration are often used interchangeably. However, these terms refer to two distinct processes and should not be confused. The main difference between validation and calibration is that validation confirms that a product meets its intended requirements. In contrast, calibration ensures that a product’s components are correctly adjusted or configured.  

While initial calibration typically happens before validation, both are important and necessary to ensure good product quality. Without validation, a product may not meet its intended requirements, but without calibration, it may not perform as designed even if it meets those requirements. The validation and calibration of equipment is essential for maintaining the quality, safety, and reliability of the products being produced. 

The validation and calibration of equipment in the pharmaceutical or life science industry is important for several reasons:  

  • It helps to ensure the accuracy and precision of the measurements taken during the manufacturing process. This is essential for maintaining the quality and safety of the final product.  
  • It helps to ensure that the equipment is working properly and can consistently produce accurate results. This is important for maintaining regulatory compliance and avoiding costly errors or recalls.  
  • Regular validation and calibration of equipment can also help to identify potential problems or issues before they become more serious, allowing for timely maintenance and repair.  

The role of PSC Biotech

For manufacturing equipment, validation services from PSC include designing a validation strategy and preparing detailed validation protocols, protocol execution, and final report preparation. These services help to ensure that the equipment meets all applicable regulations and standards. PSC also offers support services such as reviewing existing validation plans, creating new ones, and providing validation training. Additionally, PSC Biotech metrology team offers field and in-lab calibrations using NIST-traceable standards to ensure valid and updated calibration certificates are available during the validation process. 

 For laboratory equipment, PSC works with companies to design and implement validation plans that meet the requirements of quality control laboratories. This includes ensuring that the equipment meets the appropriate safety standards and other requirements and that it can perform the tests and experiments it is designed for. PSC also offers support services, such as technical advice and comprehensive reports to ensure that the validation process is successful.  

PSC Biotech is a great partner for companies looking for validation services for their manufacturing and analytical equipment. Our services and expertise ensure that the equipment is safe and effective and that the company can continue to produce quality products. PSC Biotech is dedicated to helping companies meet their validation requirements to continue to operate safely and efficiently. We have specialists in manufacturing equipment, quality control laboratory, and analytical instrument areas who can help develop validation documents and execute them through our team of 500 consultants around the country. Connect with us today to learn to learn about our equipment validation services.

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