Demystifying CQV – Essential Insights for Compliance

Demystifying CQV – Essential Insights for Compliance

The Commissioning, Qualification, and Validation (CQV) whitepaper presents a strategic approach to ensuring systems, processes, and equipment integrity and compliance in regulated industries.

Here’s what you’ll uncover in our new white paper:

Comparing Commissioning, Qualification, and Validation: Gain unparalleled insights into the intricacies and best practices surrounding these essential processes within regulated industries

Strategies for CQV: Unveil cutting-edge approaches and industry insights to optimize CQV processes for enhanced regulatory compliance and operational excellence.

Critical elements of CQV: We cover the essential components and strategic insights surrounding the key elements of CQV, driving efficiency and compliance in regulated environments.

Whether you’re navigating the fundamentals or honing advanced expertise, our whitepaper proves indispensable, providing lucid perspectives and actionable insights into the intricacies of CQV, guiding professionals at every level.

Download our free white paper and equip yourself with the knowledge to implement effective CQV strategies!

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Overview of the whitepaper about CQV by PSC Biotech

PSC Biotech, a leading expert in CQV consulting, is dedicated to enhancing global life sciences enterprises’ operational integrity and regulatory compliance. Our mission involves providing customized professional assistance, seamlessly integrating with your organization, improving product quality, and ensuring operational efficiency and compliance. Collaborate with us to elevate your CQV standards and surpass industry benchmarks.

 

We look forward to hearing about your needs in CQV. Please get started by emailing us at sales@biotech.com or using our contact form.

Download the CQV White Paper today!

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How Can Outsourcing Professional Services Boost Your Company?

How Can Outsourcing Professional Services Boost Your Company?

Outsourcing written with people in the background - PSC Biotech Outsurcing Professional Services

In the dynamic landscape of modern business, companies constantly seek innovative strategies to streamline operations, enhance productivity, and drive growth. One such strategy that has gained significant traction in recent years is outsourcing professional services. From Commissioning, Qualification, and Validation (CQV) support to Computer System Validation (CSV), auditing, and beyond, outsourcing has emerged as a powerful tool for companies looking to optimize their resources and focus on core competencies. 


This blog post delves into the myriad of ways outsourcing professional services can propel your company forward. Whether you are a small startup or a multinational corporation, harnessing the expertise of external service providers can unlock a host of benefits, ranging from cost savings and scalability to access to specialized skills and technologies. 

Outsourcing professional services can offer numerous advantages to companies of all sizes. Some of the key benefits include: 

1. Cost Savings: Outsourcing allows companies to access skilled professionals and specialized services at a lower cost than hiring full-time employees. This is particularly beneficial for small and medium-sized businesses with limited budgets.

2.
Focus on Core Competencies: By strategically outsourcing non-core functions such as accounting, IT support, or customer service, companies can optimize their resources and focus on core business activities. This includes pivotal tasks like validation and maintaining quality standards, which bolsters a company’s growth trajectory and success.

3. Access to Specialized Expertise: Outsourcing enables companies to tap into the expertise and experience of professionals in specific fields or industries that may not be available in-house. This can lead to higher quality work and improved regulatory affairs, auditing, compliance, or inspection outcomes.

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4. Scalability and Flexibility: Outsourcing allows companies to scale their operations up or down quickly in response to changing business needs or market conditions. This flexibility can be precious for startups or expanding companies with capital projects. 

5. Improved Efficiency and Productivity: Outsourcing tasks to specialized service providers often results in increased efficiency and productivity, as these providers are typically equipped with the latest tools, technologies, and best practices in their respective fields. 

6. Risk Mitigation: Outsourcing certain functions can help companies mitigate risks associated with regulatory compliance, technology obsolescence, or market fluctuations. Service providers are often responsible for staying updated with industry regulations and standards, reducing the burden on the company.

7. Time Savings: Outsourcing allows companies to save time on recruiting, training, and managing in-house staff for non-core functions. This time can be reinvested into strategic activities that drive business growth and innovation.

8. Enhanced Focus on Customer Satisfaction: By outsourcing operational functions or support services, companies can allocate more resources to improving customer experience and satisfaction, ultimately strengthening customer relationships and loyalty.

9. Enhanced Innovation and Adaptability: Outsourcing professional services promotes innovation and adaptability by exposing companies to new ideas and industry insights through collaboration with external experts. Working across organizational boundaries facilitates knowledge sharing and integration of diverse perspectives and best practices that can help companies identify trends, opportunities, and areas for improvement. 

Control Operating Costs While Achieving Growth:

Outsourcing professional services contains costs while providing the bandwidth to achieve aggressive growth targets. Outsourcing professional services to PSC Biotech offers several distinct advantages for companies operating in the biotechnology and pharmaceutical industries. PSC Biotech is a leading global provider of compliance consulting services, cloud-based software solutions, engineering support, and professional services tailored to the life sciences sector.  

Here are some of the key advantages of outsourcing to PSC Biotech:

1) Specialized Expertise: PSC Biotech boasts a team of highly skilled professionals with extensive experience and expertise in regulatory compliance, quality management, validation, and engineering within the life sciences industry. By outsourcing to PSC Biotech, companies can tap into this specialized knowledge base and leverage best practices to ensure compliance with stringent regulatory requirements and industry standards. 

2) Regulatory Compliance: PSC Biotech offers comprehensive consulting services to help companies comply with global regulatory agencies such as the FDA, EMA, MHRA, or TGA. By outsourcing compliance-related tasks to PSC Biotech, companies can mitigate compliance risks, avoid costly regulatory violations, and uphold the integrity and quality of their products and processes.

3) Quality Management: Maintaining high-quality standards is paramount in the life sciences industry, where patient safety and product efficacy are non-negotiable. PSC Biotech provides quality management solutions tailored to biotechnology and pharmaceutical companies’ unique needs and challenges. PSC Biotech helps organizations optimize their quality processes, enhance product quality, and achieve operational excellence. 

By leveraging the capabilities and resources of PSC Biotech, companies can enhance their competitiveness, streamline their operations, and achieve their strategic objectives with confidence. 

Start your journey towards excellence and connect with PSC Biotech’s experts today.  

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CQV: Where to Start? A Comprehensive Guide to Commissioning, Qualification, and Validation

CQV: Where to Start? A Comprehensive Guide to Commissioning, Qualification, and Validation

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As the life science industries continue to evolve, the emphasis on regulation, safety, and efficiency is more pronounced than ever. Verifying a company has and follows standard operational procedures (SOPs) addressing each category using the tried-and-true methods of Commissioning, Qualification, and Validation (CQV) ensures compliance with FDA regulations. Yet, navigating the path to comprehending CQV can be overwhelming for some.   


Let PSC Biotech help guide you with our practical guide on how to start with CQV.  

Understanding CQV 

CQV is the process used by pharmaceutical and life science industries to ensure that a facility, its systems, and equipment fit their intended purpose. This process involves specific verification activities being tested against requirements and specifications. ISPE defines the Commissioning process as a systematic approach to the start-up and turnover of facilities, systems, and equipment to end-users and ensuring that user requirements and design specifications are met. The qualification process refers to verifying that a piece of equipment, system, or software meets the requirements and specifications for its intended purpose. While the validation process focuses on providing the specified performance and results in the user requirements.   

At a high level, there are eight steps in implementing a CQV at a facility.  

A flow chat showing 9 different stages of implementing CQV at a facility by PSC Biotech

The nine key stages of implementing CQV at a facility.

Step One: Analyzing Project Scope 

The first step to implementing a CQV process is to define the project’s scope with a comprehensive understanding of the validation lifecycle and risk mitigation approach. This includes detailing the systems and processes, defining goals, requirements, and specifications identifying potential hazards, and performing assessments (Failure Mode and Effect Analysis (FMEA), cGxP, Data Integrity, 21 CFR Part 11, etc.) that the equipment will be tested against.  

Step Two: Building a Team 

CQV is a team effort that requires effective coordination and collaboration. Ideally, the team comprises subject matter experts (SMEs) in the type of facility under construction, equipment, and software lifecycle while following FDA Regulations. The team is well balanced by incorporating at least one validation engineer, a project manager, or liaison with the general construction contractor and including the quality assurance lead to oversee the CQV process. Each team member brings a unique perspective and strength to the project’s success.   

Step Three: Developing the Master Validation Plan (MVP)  

The roadmap for your CQV implementation comes in the form of a Master Validation Plan—a pivotal document giving an overview of the company’s validation strategy, outlining the key roles and responsibilities, timelines, risk assessment procedures, the testing and acceptance criteria, and stating the company programs ensuring a continuing state of validation. Each company may have an SOP defining the content of what in the Master Validation Plan has a template available.  

Step Four: Commissioning 

Commissioning will be conducted to ensure the facility is correctly designed and built. This will be confirmation of the utilities (air, water, HVAC, power, etc.) performed per design. This testing is not considered Good Manufacturing Practices (GMP), as it does not focus on product impact.  

Step Five: Equipment Qualification  

The next step of equipment qualification is essential in ensuring finished goods are delivered under repeatable parameters. It includes the Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). DQ provides document verification that the design of the new equipment will result in a system suitable for the intended use. IQ confirms that the equipment is installed correctly and verifies the design specifications. OQ ensures the machine operates per functional specifications. Lastly, PQ confirms that the equipment consistently performs to user specifications in production situations.  Some company SOPs require all these documents, while others allow flexibility by only performing a limited number of qualifications. Including the Quality Assurance (QA) department in those discussions is the best.  

Step Six: Validation 

Process Validation can be defined as generating documented evidence that processes can consistently produce finished goods meeting quality specifications. This will round out the qualification activities and release the equipment for use.  

Step Seven: Continued Process Verification 

Once the facility has been validated per the MVP, the next focus is to ensure that the process remains controlled during routine production.  This is called Continued Process Verification (CPV).  It consists of continued assessments of the parameters and attributes within the control strategy as defined in the process design and refined at the end of process qualification.  

Step Eight: Maintaining a State of Compliance 

Finally, congruent with maintaining FDA Regulations, it’s critical to regularly review and audit your validation protocols and processes to confirm compliance, especially considering any changes made to the systems or process. The quality unit of the company typically performs this.   

We will cover other systems and processes such as validation for software, data integrity, computer systems, and so forth, which will be discussed in our upcoming blogs. 

Here are some current CQV industry guideline references for further reading:  

Our Commissioning, Qualification, and Validation Engineers and Project Managers are available to lead and assist you at any level in your project needs.  

How can PSC Biotech Engineers and Project Managers help with your projects. A man in blue standing on the right with a open chart.

Ready to take the first step towards mastering CQV and optimizing your processes?

Start your journey towards excellence and connect with PSC Biotech’s experts today.  

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PSC Biotech CSV Services

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This interactive carousel offers a concise and engaging exploration of PSC Biotech’s CSV (Computer System Validation) services. CSV is a critical component mandated by the FDA to ensure the accuracy, reliability, and consistency of computer systems used in the life sciences industry.

This carousel is your go-to resource for:

  • This carousel provides a thorough overview of PSC Biotech’s CSV service.
  • How can PSC Biotech cater to the intricate requirements of CSV, ensuring compliance with FDA mandates and other regulatory standards?
  • It distills the expertise and extensive experience of PSC Biotech’s professionals, giving you access to industry best practices and cutting-edge approaches. 
  • The carousel aids in informed decision-making, whether you’re considering CSV services for your company or looking to improve your current systems.

CSV is your gateway to earning trust and setting benchmarks in life science excellence. 

To learn more about Computer System Validation, click here.

 

Schedule a call with our Subject Matter Experts (SMEs) by clicking here.

 

For any questions and queries, please send an email to sales@biotech.com.

CSV Vs CSA – Unpacking FDA’s Revised Software Validation

CSV Vs CSA – Unpacking FDA’s Revised Software Validation

Embrace cutting-edge innovation in Quality Assurance (QA) through a comprehensive understanding of Computer System Validation Vs. Computer System Assurance (CSV Vs. CSA).

Here’s what you’ll uncover in our enlightening white paper:

Comparing CSV and CSA: Obliterate the confusion surrounding CSV and CSA’s distinctive features, functions, and strategic implications in quality assurance procedures.

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Whether you are just dipping your toes or are a seasoned expert in the field of Quality Assurance, our white paper serves as a valuable resource, offering clarity and practical insights into understanding CSV and CSA.

Download our free white paper and equip yourself with the knowledge to implement effective CSV and CSA strategies!

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As a global leader specializing in CSV and CSA consulting services, PSC Biotech® works to ensure life sciences companies’ processes are functional and fully compliant with FDA and EMA guidelines. Our goals are to provide tailored professional services, provide a seamless extension of life science companies, assist you in producing the highest quality products possible, and ensure processes are functional and compliant.

 

We look forward to hearing about your needs in CSA and whether we can be of service. Please get started by emailing us at sales@biotech.com or using our contact form.

Download the CSA vs CSV White Paper today!

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