January 2018 - rfxcel.com
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Month: January 2018

Compliance Checklist – CFR Title 21 Part 11 and EU Annex 11

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EU Annex 11 & 21 CFR Part 11 Compliance Checklist

The United States Food and Drug Administration (FDA) and the European Commission have defined regulations for the conditions under which regulated companies can submit electronic records in lieu of paper documents.

These regulations define the measures that must be in place to ensure the integrity, trustworthiness, and reliability of the electronic records.

The regulations define and require three types of controls:

  1. Administrative controls, e.g. the definition of policies such as the identification of individuals and non-repudiation of electronic records.
  2. Procedural controls, e.g. Standard Operating Procedures for using and maintaining the system.
  3. Technical controls e.g. functions built into the software such as security and access to the system as well as the audit trail

For compliance with the regulation, all three of the above controls must be implemented.

rfxcel Implementation Plan (Part 7 of 7) – Switching Serialization Providers

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Switching Serialization Providers – Learn more about the process of switching to rfxcel’s serialization implementation plan:

About the speakers:

Rose Campasano, Vice President of Professional Services at rfxcel, is a collaborative leader with over 20 years of IT leadership experience encompassing infrastructure, applications, and business processes. She focuses on nurturing long-lasting, trusted partnerships with rfxcel clients and their integration partners.  She excels at employee motivation and coaching demonstrated by a high performing team.

Herb Wong, Vice President of Marketing at rfxcel, is responsible for defining the rfxcel product roadmap and marketing strategy. He also ensures the coordination of rfxcel’s marketing message and product offering and provides leads and collateral for Sales team members.

In the final segment of the interview, Rose and Herb explain the process of switching between serialization providers and how the process is conducted by the rfxcel team.

There isn’t much difference between starting a brand new implementaion process and replacing the existing one. The reason for this is that we have a good understanding of nearly all the other existing serialization partners since we have been working with them for two years. Because we have worked with them on the daily basis, our team knows their software as well as our own. It is therefore easy to transition into our software, which we have successfuly done a number of times.

„We’ve been doing this for so many implementations already. We have a standard set of documentation that we’re using. We have templates. We have a set of user requirements that are well defined for the industry it actually works. At the kick off meeting we’re already bringing you a development system that looks like your system,” says Rose.

In essence, we have all of the validation documentaion already prepared and we’re building further based on your specific configuration. We are able to show you at the very start that the half of the documentaion is alrady going to be in your hands in the first week.

rfxcel Serialization Implementation Plan is easily configured according to your specific needs and demands. Our team is with you through every step of the process and we offer support during the entire time you are using our services. To help you get a detailed idea of our Serialization Implementation Plan, we have discussed our Plan in seven segments:

  1. Serialization Implementation Plan based on Audit Needs
  2. Boost Serialization Implementation with a Global Team
  3. Global Serialization Implementation Team for Global Customers
  4. A Serialization Solution Provider Focused on the Long Term Relationship
  5. Common Challenges in Serialization Implementations
  6. Implementation kick off with rfxcel
  7. Switching Serialization Providers

 

Switching Serialization Providers with rfxcel

rfxcel Implementation Plan (Part 6 of 7) – Serialization Implementation kickoff with rfxcel

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Serialization Implementation kickoff with rfxcel 

Learn more about rfxcel’s serialization implementation kickoff plan and how we structure our kick offs:

About the speakers:

Rose Campasano, Vice President of Professional Services at rfxcel, is a collaborative leader with over 20 years of IT leadership experience encompassing infrastructure, applications, and business processes. She focuses on nurturing long-lasting, trusted partnerships with rfxcel clients and their integration partners.  She excels at employee motivation and coaching demonstrated by a high performing team.

Herb Wong, Vice President of Marketing at rfxcel, is responsible for defining the rfxcel product roadmap and marketing strategy. He also ensures the coordination of rfxcel’s marketing message and product offering and provides leads and collateral for Sales team members.

In this segment of the interview Rose explains how our kick off is structured.

Each kick off is structured based on the needs of the organization with which we are partnering, depending on where they are in their serialization program, especially depending on the organization’s prior experience and how familiar they are with the supply chain and serialization process.

“We tailor those discussions so they could be anywhere from a day where we’re in in the morning and we’re out again at the end of the day. Or, it could be up to two and a half days depending on what we need to cover and how many partners they have, and what their business model is,” says Rose.

rfxcel Serialization Implementation Plan is easily configured according to your specific needs and demands. Our team is with you through every step of the process and we offer support during the entire time you are using our services. To help you get a detailed idea of our Serialization Implementation Plan, we have discussed our Plan in seven segments:

  1. Serialization Implementation Plan based on Audit Needs
  2. Boost Serialization Implementation with a Global Team
  3. Global Serialization Implementation Team for Global Customers
  4. A Serialization Solution Provider Focused on the Long Term Relationship
  5. Common Challenges in Serialization Implementations
  6. Implementation kick off with rfxcel
  7. Switching Serialization Providers

 

 

serialization implementation kickoff rfxcel

rfxcel Implementation Plan (Part 5 of 7) – Common Serialization Challenges During Implementations

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Learn about serialization challenges in implementation with rfxcel experts:

About the speakers:

Rose Campasano, Vice President of Professional Services at rfxcel, is a collaborative leader with over 20 years of IT leadership experience encompassing infrastructure, applications, and business processes. She focuses on nurturing long-lasting, trusted partnerships with rfxcel clients and their integration partners.  She excels at employee motivation and coaching demonstrated by a high performing team.

Herb Wong, Vice President of Marketing at rfxcel, is responsible for defining the rfxcel product roadmap and marketing strategy. He also ensures the coordination of rfxcel’s marketing message and product offering and provides leads and collateral for Sales team members.

There are certain common serialization challenges during serialization implementation and in this part of the interview, Rose and Herb will explain what those challenges are.

The biggest challenge is not recognizing who is the owner of the relationship in the organization that has many business relationships with all their trading partners. Each company can have multiple roles. A company can be an independent manufacturer who manufactures and sells for themselves. On the other hand, they could manufacture for themselves or someone else and be a service while believing that the ownership is actually a service that they’re providing to another company.

Understanding how the relationship is built and understanding who is the owner of the relationship plays an important part in being able to install the connection correctly from a serialization standpoint.

“Realizing where those relationships really are and how they’re structured will help us understand how we need to configure your system. You have to know who’s going to own the serial numbers, who’s going to be responsible for tracking them and who would be accountable to the auditors or the FDA when they come in.” says Rose.

As a part of kickoff that we do, we actually understand what it means to do business in your shop.

rfxcel Serialization Implementation Plan is easily configured according to your specific needs and demands. Our team is with you through every step of the process and we offer support during the entire time you are using our services. To help you get a detailed idea of our Serialization Implementation Plan, we have discussed our Plan in seven segments:

  1. Serialization Implementation Plan based on Audit Needs
  2. Boost Serialization Implementation with a Global Team
  3. Global Serialization Implementation Team for Global Customers
  4. A Serialization Solution Provider Focused on the Long Term Relationship
  5. Common Challenges in Serialization Implementations
  6. Implementation kick off with rfxcel
  7. Switching Serialization Providers

 

Serialization Challenges, mplementation challenges, serialization implementation rfxcel,

rfxcel Implementation Plan (Part 4 of 7) – A Serialization Solution Provider Focused on the Long Term Relationship

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A Serialization Solution Provider Focused on the Long Term Relationship, Customer Success

Learn more about rfxcel’s serialization implementation plan and how we are focused on the long term relationship with our clients:

About the speakers:

Rose Campasano, Vice President of Professional Services at rfxcel, is a collaborative leader with over 20 years of IT leadership experience encompassing infrastructure, applications, and business processes. She focuses on nurturing long-lasting, trusted partnerships with rfxcel clients and their integration partners.  She excels at employee motivation and coaching demonstrated by a high performing team.

Herb Wong, Vice President of Marketing at rfxcel, is responsible for defining the rfxcel product roadmap and marketing strategy. He also ensures the coordination of rfxcel’s marketing message and product offering and provides leads and collateral for Sales team members.

Rose and Herb talk about the qualities of rfxcel Serialization Implementation Team focused on the long term relationship with our clients.

Rose started her career in the IT sector which gives her the vantage point. She understands that customers, especially those in the pharmaceutical space, are often given people who don’t understand their industry. This is not the case with our team. We understand the importance of validation and we understand what it means to you to get it right.

We at rfxcel want our customers to know that we have a tremendous amount of integrity in what we do and that we are here to support you in every step of the process, during the time you are using our services. We will be at your disposal, offering help and support, and partnering with you during and after the software installation process.

rfxcel Serialization Implementation Plan is easily configured according to your specific needs and demands. Our team is with you through every step of the process and we offer support during the entire time you are using our services. To help you get a detailed idea of our Serialization Implementation Plan, we have discussed our Plan in 7 segments:

  1. Serialization Implementation Plan based on Audit Needs
  2. Serialization Implementation Team from Start to Finish
  3. Global Serialization Implementation Team for Global Customers
  4. A Serialization Solution Provider Focused on the Long Term Relationship
  5. Common Challenges in Serialization Implementations
  6. Implementation kick off with rfxcel
  7. Switching Serialization Providers

customer success with rfxcel, Serialization Solution Provider rfxcel

rfxcel Implementation Plan (Part 3 of 7) – Global Serialization Implementation Team for Global Customers

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Learn more about rfxcel’s serialization implementation team and plan to meet your global compliance and serialization requirements:

About the speakers:

Rose Campasano, Vice President of Professional Services at rfxcel, is a collaborative leader with over 20 years of IT leadership experience encompassing infrastructure, applications, and business processes. She focuses on nurturing long-lasting, trusted partnerships with rfxcel clients and their integration partners.  She excels at employee motivation and coaching demonstrated by a high performing team.

Herb Wong, Vice President of Marketing at rfxcel, is responsible for defining the rfxcel product roadmap and marketing strategy. He also ensures the coordination of rfxcel’s marketing message and product offering and provides leads and collateral for Sales team members.

In this segment of the interview, Rose explains the structure and benefits of having a global team in order to meet the needs of global customers.

rfxcel has a Professional Service team structured by technical project managers who are responsible for a full project plan, and IT professionals who look at customer’s partner connections and integrations. Rose has managed to leverage a global team and explains the thought process in putting it together.

To be able to work with a variety of different groups whose manufacturing plant and manufacturing organizations may be in different parts of the world, it was necessary to structure a global team because these groups would be using vendors that are offshore, in other countries.

“To make you transcend your trading partner connections, we needed to make sure that we had an organization that can actually work in those different time zones.” says Rose.

In order to meet these needs, our global team is positioned in the US, offshore and in both Europe and India. We don’t assign you just one person, but a group of people. That way when work stops in one place, it can be continued in a different time zone which greatly benefits everyone.

rfxcel Serialization Implementation Plan is easily configured according to your specific needs and demands. Our team is with you through every step of the process and we offer support during the entire time you are using our services. To help you get a detailed idea of our Serialization Implementation Plan, we have discussed our Plan in 7 segments:

  1. Serialization Implementation Plan based on Audit Needs
  2. Serialization Implementation Team from Start to Finish
  3. Global Serialization Implementation Team for Global Customers
  4. A Serialization Solution Provider Focused on the Long Term Relationship
  5. Common Challenges in Serialization Implementations
  6. Implementation kick off with rfxcel
  7. Switching Serialization Providers

implementation team rfxcel

 

rfxcel Implementation Plan (Part 2 of 7) – Boost Serialization Implementation

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Boost serialization implementation with a global team from start to finish and beyond. 

Learn more about rfxcel’s serialization implementation plan:

About the speakers:

Rose Campasano, Vice President of Professional Services at rfxcel, is a collaborative leader with over 20 years of IT leadership experience encompassing infrastructure, applications, and business processes. She focuses on nurturing long-lasting, trusted partnerships with rfxcel clients and their integration partners.  She excels at employee motivation and coaching demonstrated by a high performing team.

Herb Wong, Vice President of Marketing at rfxcel, is responsible for defining the rfxcel product roadmap and marketing strategy. He also ensures the coordination of rfxcel’s marketing message and product offering and provides leads and collateral for Sales team members.

In this segment of the interview, Rose and Herb talk about the structure of the rfxcel Professional Service team to boost serialization implementation.

rfxcel has a global Professional Service team structured by different teams of people assigned to the specific parts of the implementation process. Technical project managers are in charge of the initial implementation. They not only do a project plan but also understand and configure the system based on your specific needs. We have a team of IT professionals in charge of validation and testing. They look into your operational qualification with the ability to test your programs and make sure that the serialization process is in compliance with your validation plan. Furthermore, we assign a team dedicated to being your integration partners. They look at your partner connections as we move beyond implementing the software. We designate a team to every customer, and they are obligated to attend every meeting from the beginning. Also, we want our customers to be able to call our project managers with questions, issues they might be facing, support and most of all to build a trusted relationship.

Our Professional Service team at rfxcel has successfully done this serialization implementation process many times. Based on our experience, we offer services that are effective and work.

“We’re the company that’s going to make sure that we partner with you start to finish and beyond the whole idea of our departments. Our goal from the professional services perspective is to make sure that we understand what you need, what your company needs and how your serialization product needs to actually be designed and implemented for you.” says Rose.

The serialization work goes beyond simply installing the software. When you’re looking for a vendor, it is important to look for someone who is going to partner with you. Our rfxcel team offers partnership through the implementation, supporting you through every step of the process.

rfxcel Serialization Implementation Plan is easily configured according to your specific needs and demands. Our team is with you through every step of the process and we offer support during the entire time you are using our services. To help you get a detailed idea of our Serialization Implementation Plan, we have discussed our Plan in seven segments:

  1. Serialization Implementation Plan based on Audit Needs
  2. Boost Serialization Implementation with a Global Team
  3. Global Serialization Implementation Team for Global Customers
  4. A Serialization Solution Provider Focused on the Long Term Relationship
  5. Common Challenges in Serialization Implementations
  6. Implementation kick off with rfxcel
  7. Switching Serialization Providers

 

rfxcel Implementation Plan (Part 1 of 7) – Serialization Implementation Plan Based on Pharmaceutical Audit Needs

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A compliance management and serialization process based on pharmaceutical audit needs.

Learn more about rfxcel’s serialization implementation plan and how we based it on pharmaceutical audit:

About the speakers:

Rose Campasano, Vice President of Professional Services at rfxcel, is a collaborative leader with over 20 years of IT leadership experience encompassing infrastructure, applications, pharmaceutical audit and business processes. She focuses on nurturing long-lasting, trusted partnerships with rfxcel clients and their integration partners.  She excels at employee motivation and coaching demonstrated by a high performing team.

Herb Wong, Vice President of Marketing at rfxcel, is responsible for defining the rfxcel product roadmap and marketing strategy. He also ensures the coordination of rfxcel’s marketing message and product offering and provides leads and collateral for Sales team members.

In this interview Rose and Herb talk about how Rose’s prior experience in IT and pharmaceutical industries helps her prepare our team to make a foolproof validation plan.

Rose has experience working in the large pharmaceutical company where she put a whole validation and IT governance plan in place. She decided to take a different approach to the validation plan, and looked at compliance from the pharmaceutical audit and auditor’s perspective.

“When you are generally learning about validation, you go to validation classes.  But I tried to look at it from a different perspective, and I went to audit classes instead. I went and learned as though I was an auditor, and so that actually gave me insight into the best practices for how to avoid the pitfalls of not giving yourself a good validation plan“, says Rose.

Approaching the implementation process from the pharmaceutical audit and auditor’s perspective has enabled our team greater insight into the best practices for making a good validation plan based on your needs.

“We’re the company that’s going to make sure that we partner with you start to finish and beyond the whole idea of our departments. Our goal from the professional services perspective is to make sure that we understand what you need, what your company needs and how your serialization product needs to actually be designed and implemented for you.” says Rose.

The serialization work goes beyond simply installing the software. When you’re looking for a vendor, it is important to look for someone who is going to partner with you. Our rfxcel team offers partnership through the implementation, supporting you through every step of the process.

rfxcel Serialization Implementation Plan is easily configured according to your specific needs and demands. Our team is with you through every step of the process and we offer support during the entire time you are using our services. To help you get a detailed idea of our Serialization Implementation Plan, we have discussed our Plan in seven segments:

  1. Serialization Implementation Plan based on Audit Needs
  2. Serialization Implementation Team from Start to Finish
  3. Global Serialization Implementation Team for Global Customers
  4. A Serialization Solution Provider Focused on the Long Term Relationship
  5. Common Challenges in Serialization Implementations
  6. Implementation kick off with rfxcel
  7. Switching Serialization Providers

rfxcel Serialization Implementation Plan (Full Interview)

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Learn more about rfxcel’s serialization implementation plan:

About the speakers:

Rose Campasano, Vice President of Professional Services at rfxcel, is a collaborative leader with over 20 years of IT leadership experience encompassing infrastructure, applications, and business processes. She focuses on nurturing long-lasting, trusted partnerships with rfxcel clients and their integration partners.  She excels at employee motivation and coaching demonstrated by a high performing team.

Herb Wong, Vice President of Marketing at rfxcel, is responsible for defining the rfxcel product roadmap and marketing strategy. He also ensures the coordination of rfxcel’s marketing message and product offering and provides leads and collateral for Sales team members.

Rose and Herb talk about the rfxcel Serialization Implementation Plan, how it is structured, configured, and implemented. By utilizing industry best practices, and understanding the needs of the clients, Rose implements rfxcel’s end-to-end traceability solution with a full-service approach and mindset.

Rose looks at validation from an auditor’s perspective which enables her to gain insight into the best practices. This approach minimizes risks of not having a good validation plan, a method which she coaches the rest of her team. rfxcel has a global Professional Service team structured by technical project managers who are responsible for a full project plan, and IT professionals who look at customer’s partner connections and integrations.

“We want our customers to recognize that we have a tremendous amount of integrity in what we do and we are there through every step of the process. We at rfxcel understand the importance of validation and qualification for pharmaceutical companies. It is important to understand how the relationship between trading partners and who is the owner of that relationship. Once we understand the structure of those relationships, it helps us understand how to configure our customer’s system.” says Rose.

On the first day of any onboarding kickoff, we make sure we understand your business plan to start a new or build on the existing implementation process of your company. Since we’ve been doing this for so many implementations over the last fourteen years, we have a standard set of documentation, templates, that we’re using. We have a set of user requirements that are well defined for the industry and make the implementation process seamless. At the kickoff meeting we’re already bringing you a development system that looks like yours, a system already ready for you. We have recipes already built in for the serialization. This approach ensures customers to know the implementation roadmap, what to expect and how rfxcel will support them in every step of the road.

rfxcel Serialization Implementation Plan is easily configured according to your specific needs and demands. Our team is with you through every step of the process and we offer support during the entire time you are using our services. To help you get a detailed idea of our Serialization Implementation Plan, we have segmented this interview and discussed our Plan in 8 segments:

  1. Have an Implementation Serialization Plan with rfxcel
  2. Serialization Implementation Plan based on Audit Needs
  3. Serialization Implementation Team from Start to Finish
  4. Global Serialization Implementation Team for Global Customers
  5. A Serialization Solution Provider Focused on the Long Term Relationship
  6. Common Challenges in Serialization Implementations
  7. Implementation kick off with rfxcel
  8. Switching Serialization Providers

EU Falsified Medicines Directive Webinar: What to Know & Where to Begin

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THIS WEBINAR ENDED. YOU CAN ACCESS THE RECORDING BELOW.

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EU Falsified Medicines Directive Webinar: What to Know & Where to Begin

Presented by: Mark Davison, Serialization Expert for rfxcel based in UK

Webinar recording: /webinar-eu-falsified-medicines-directive/

Also read: The EU Falsified Medicine Directive Webinar Follow-Up: 14 Answered Question from rfxcel serialization expert Mark Davison

 

 

Tuesday, January 30, 2018 – Webinar has ended!

A webinar by rfxcel to provide insight into the upcoming serialization requirements, and learn how to ensure your organization is on track to compliance. In this 45 minute presentation, we will discuss:

1. An overview of key features of the EU Falsified Medicines Directive.

2. What does this mean for Marketing Authorization Holders (MAHs), Distributors and Dispensers?

3. Who does what? The role(s) of Small or Virtual MAHs and Contract Manufacturers explained.

4. Explanation of the EMVO process, and steps to onboarding your organization.

5. Considerations when selecting a certified gateway provider.

6. Timelines, resource needs, validation and other issues.

About rfxcel:

rfxcel is the leading provider of SaaS-based track and trace solutions. The platform enables companies to protect patients, comply with regulatory mandates, and gain visibility into their supply chain. rfxcel’s relentless commitment to customer success and continuous innovation ensures that companies can meet today’s requirements and tomorrow’s challenges.

PLEASE FILL OUT FORM TO ACCESS WEBINAR RECORDING:

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