Life science companies deal with tons of data; this data could be related to processes (manufacturing, process controls, equipment, administrative, financial, legal, medical), product (physical attributes, study reports, analytical documents, batch records), regulatory submission documents and other relevant quality documentation.  

While this data is crucial to be stored and retained in paper or electronic form, Companies must have an efficient system that maintains such documentation and records. This is especially important for compliance with quality and regulatory standards. Some specific examples of necessary project documentation for life science companies include: 

1. Protocols and standard operating procedures (SOPs): These documents outline the procedures and processes that should be followed for critical activities such as laboratory and research work, clinical trials, and manufacturing. Regulatory agencies often require them as part of the approval process for drugs and medical devices. Companies can establish an electronic document management system that can track such procedures’, generation, modification, and approval Study reports and data: Life science companies must document the results of their research and development activities, including regulatory-related data from pre-clinical and clinical trials and laboratory experiments. Regulatory agencies often require these documents as part of the approval process for drugs and medical devices. Having such documents in place helps companies keep track of the progress of their product development, any changes made in the process or to the product, and registration and approval.

    

2. Quality management records: Life science companies must maintain records of their quality project management activities, such as calibration and maintenance of equipment and training records of employees. Maintaining such quality documentation helps companies keep track of all change controls, deviations, and non-conformances related to product and quality-related processes. Regulatory agencies also use these documents to check if companies comply with GMP and other related standards during inspections and audits.
   
   
3. Audit trails: Life science companies must maintain accurate records of all changes made to project documentation, including who made the change and when the change was made and executed. Keeping an audit trail is essential for companies to maintain the integrity of the data for quality and regulatory compliance.

    

4. Archiving: Life science companies must keep records for a certain amount of time, even after the end of the project, as regulatory agencies may require access to these records during inspections and audits.

    

5. Electronic Document Management Systems (EDMS): Many life science companies use EDMS to store, manage, and track project documentation. Having an EDMS has a lot of benefits, such as easy access and retrieval, cloud-based document changes, tracking all changes, maintaining an audit trail, document version control, and archiving the documents. 

While maintaining project documents is essential, not having a good project documentation system can lead to several disadvantages for life science companies, including: 

1. Compliance issues: Life science companies are subject to strict regulations. Most regulated products are meant for human use and must be controlled in all aspects, impacting product quality, safety, and efficacy. Failure to maintain proper documentation can result in non-compliance and potential penalties such as Warning Letters, 483s, suspension, or withdrawal of products from the market.

    

2. Poor quality control: Without proper documentation, it can be difficult to ensure that products and processes meet quality standards or track changes to the product and related processes.

    

3. Difficulty in reproducibility: Without proper documentation, it can be difficult for other researchers or teams to reproduce experiments, tests, or processes. This can slow progress, impede collaboration, and cause process variation that could impact product quality. This can also affect making and replicating planned changes to the product or processes as per change controls, deviations, or non-conformances. Not having a centralized documentation system can also cause all affected employees not to have access to critical data required to make changes or revisions.

    

4. Inefficient use of resources: Not having a good project documentation system can lead to wasted time and resources as team members attempt to recreate or redo work that has already been done. 

    

5. Difficulty in tracking progress: Without proper documentation, it can be challenging to track the progress of a project and identify issues or areas that need improvement. It can also lead to not having a trail of all the changes made to a product or process. Such data are usually required during Regulatory agency inspections or audits and are crucial in determining a company’s continued compliance with quality standards. 

Overall, maintaining accurate and complete project documentation is crucial for life science companies to ensure regulatory compliance, maintain high standards of quality and safety of the product, and demonstrate the integrity of their data, documents, and processes to regulatory agencies. 

PSC software offers many electronic quality management solutions (eQMS), such as ACE and ACE Essentials, that can help your company manage all kinds of project documentation records and help you ensure all your documentation complies with relevant quality and documentation standards and regulations.  

PSC also supports developing quality-compliant processes such as cleaning, validation processes, writing SOPs, and other documents such as Batch Records, manufacturing protocols, and regulatory submission documents, which are an integral part of a good eQMS.  

PSC also has the expertise to support processes such as change control, deviations, and non-conformances and can also perform audits, risk assessments, and gap assessments to identify areas of improvement before inspections by Agencies. This can help your company ensure compliance is observed in all aspects of the system.  

Contact PSC Biotech today to understand your quality and documentation needs. 

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.   

What are the advantages of using eQMS software?   

The advantages of using eQMS software are:

Improved efficiency: eQMS software can help organizations streamline their quality management processes, which leads to more efficient operations. This allows employees to work more efficiently when reviewing documents, completing training, and more.   

Enhanced collaboration: eQMS software often includes tools for collaboration, such as document sharing and discussion forums, which can help teams improve their quality operations through collaborative feedback.   

Increased accuracy: By automating specific quality management tasks, QMS software can help reduce the risk of human errors and improve the accuracy of quality-related data. Companies no longer need to manually track the periodic review times for documents, re-training, and more.   

Enhanced customer satisfaction: By improving the quality of products and services, QMS software can help organizations provide their exceptionally best products and services to the market, thereby increasing customer satisfaction.   

Improved business performance: By improving the efficiency and effectiveness of quality management processes, eQMS software can help organizations increase overall business performance and, thus, competitiveness.   

 Improved regulatory compliance: All the improvements above culminate in an enhanced regulatory compliance position by removing room for human error and enforcing common sense checks and balances on the organization.     

PSC’s eQMS Software   

PSC Software® has developed a comprehensive eQMS software tailored to meet the needs of any organization. Our eQMS software provides a wide range of features, such as:      

• Document management: manage and track company documents to ensure that the latest versions are available to the correct employees.   
• Process improvement: monitor process performance and identify areas for improvement.   
• Training: manage and track employees’ educational courses and provide feedback as needed.    
• Quality Events: Track product and process quality and ensure conformance to standards.   
• Reporting: Generate dynamic reports to support compliance and risk management via actionable information.   
• Supplier Management   
• Inspection Management   
• Paperless Validation   
• Clinical Trial Management
• Product Lifecycle Management  

We’ve designed our software to be user-friendly and easy to understand. Our intuitive user interface and comprehensive documentation make it the most accessible software in the industry to get started with.  We provide customer support to help our customers get the most out of our software. Our customer support team is eager to answer your questions and helps you set up your system through comprehensive onboarding and training experience.   

If you’re looking for a QMS software to help you move from paper to an electronic solution, improve customer satisfaction, increase operational efficiency, and streamline your quality management processes, then PSC software® is a perfect choice. 

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 safety, functionality, 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.