5042b392-4bce-4c1d-9af8-783f6984161b

The Importance of Continuous Compliance Monitoring in Customer and Supplier Qualifications

The Importance of Continuous Compliance Monitoring in Customer and Supplier Qualifications

The Importance of Continuous Compliance Monitoring in Customer and Supplier Qualifications

In the highly regulated pharmaceutical industry, maintaining compliance isn’t just a one-time task—it’s an ongoing process. At Bonafi, we understand the critical role continuous compliance monitoring plays in ensuring the qualification of customers and suppliers.

Key Points:
1.   Regulatory Requirements: As a pharmaceutical company you must adhere to stringent regulations such as GxP and specific regional directives and guidelines. In the EU, the EU Guidelines for Good Distribution Practice (GDP) 2013/C 343/01 is crucial and is based on the Directive 2001/83/EC (Community code relating to medicinal products for human use). In the US, compliance with the FDA’s cGMP Regulations 21 CFR and taking into consideration Good Distribution Practices – Supply Chain Integrity (Chapter 1083) along with the Drug Supply Chain Security Act (DSCSA) is essential.
2.   Risk Mitigation: Continuous compliance monitoring reduces the risk of engaging with non-compliant customers or suppliers, which can lead to costly fines, product recalls, and damage to reputation. Our 365 Scanning function continuously monitors the license data of your qualified customers and suppliers, alerting you to any changes or compliance issues in real time. This proactive approach helps prevent regulatory breaches before they occur.
3.   Qualification and Requalification: Regularly verifying the credentials and compliance status of your partners is crucial. Bonafi’s tools automate the qualification and requalification processes, ensuring that all partners remain compliant over time. This helps maintain a robust and compliant supply chain network.
4.   Efficiency: Automated compliance monitoring saves time and resources, allowing your team to focus on core business activities rather than manual checks. This efficiency is particularly important when dealing with a large number of partners. A significant portion of employees’ time is spent collecting data from various websites and in different formats to support license validation. The Bonafi system efficiently retrieves this data from global register sources, reducing the risk of collecting incorrect information, and allowing your employees to use one application for all their license data retrieval needs.

Conclusion:
Maintaining continuous compliance in the qualification of customers and suppliers is not just about avoiding penalties—it’s about ensuring the delivery of safe and effective products to patients. Bonafi’s advanced compliance monitoring tools provide peace of mind and operational efficiency, helping you stay ahead in a regulated industry.Stay compliant. Stay ahead. Choose Bonafi.

Bonafi_CEO_Katarina_Antill

Meath Startup Bonafi Eyes International Expansion: Our Feature in the Business Post

Meath Startup Bonafi Eyes International Expansion: Our Feature in the Business Post

26 November 2023 – We’re excited to share a recent feature about Bonafi in the Business Post, highlighting our journey, growth ambitions, and the innovative impact we’re making in the pharmaceutical industry.

Dive into the article to discover how we’re setting a new gold standard in pharma compliance and our plans for global expansion. A big thank you to the Business Post for this coverage.

Meath start-up Bonafi on track for further growth as it eyes international expansion

 

Neale Richmond, Minister of State for business, employment & retail cuts the ribbon with Katarina, CEO of Tech startup Bonafi  and members of the company at Oaktree Business Park, Trim, Co. Meath
No Fee for repro-single use only
Photo by Kevin McFeely FLY media

BONAFI ANNOUNCES LAUNCH AND OPENING OF MEATH OFFICE

BONAFI ANNOUNCES LAUNCH AND OPENING OF MEATH OFFICE

17 November 2023Minister of State for Business, Employment and Retail Neale Richmond TD today officially opened the new office space of life science technology company, Bonafi, in Trim in County Meath. Bonafi Limited, a pioneer in compliance technology for the life sciences sector, today also announced the launch of its ground-breaking platform, set to transform the pharmaceutical supply chain’s approach to customer and supplier qualifications.

With a current team of seven in Meath and a global footprint extending to Sweden, Spain, and Bulgaria, Bonafi aims to further expand its workforce with 10 additional hires in Meath over the next 12 months.

With recent funding achievements, including a €200K investment from Enterprise Ireland, Bonafi is set for a trajectory of swift and sustainable expansion. The board has been strengthened with the strategic appointments of Anne Nolan, Ken O’Connell, and Dave Shanahan, bringing a wealth of expertise in pharmaceuticals, finance, and global business development that aligns with Bonafi’s mission to be at the forefront of pharma compliance management.

Speaking at the event Minister Neale Richmond, highlighted the government’s endorsement of Bonafi’s contribution and commitment to regional employment and technological innovation. “I am delighted to join Bonafi today to celebrate the opening of their new office space and their €200,000 investment from Enterprise Ireland. This Government is prioritising balanced regional development and it is companies like Bonafi, who will create 10 new jobs in 2024 here in Trim, who are paving the way for this growth in our regions. Launching a high-potential start up in Meath, particularly one in the regtech sector, allows for access to a wide pool of talented workers, but also supports the local economy. Today’s announcement is good for Meath, good for the Mid-East, and good for the regtech sector. I am sure that Bonafi will pave the way for other companies to launch here in Meath as well. The Government, through Enterprise Ireland, looks forward to help Bonafi continue to grow and create jobs into the future.”

CEO and Founder Katarina Antill speaks to the heart of Bonafi’s mission, stating, “Today marks a milestone for Bonafi. Our product launch, the opening of the Trim office and the enhanced leadership team underscore our resolve to set the gold standard in the industry. We’re grateful for the trust our investors have placed in us and excited about the opportunities ahead.

Anne Nolan, newly appointed Chairperson, remarked on the occasion, “The Bonafi system is a game changer for the pharmaceutical industry and will undoubtedly play a huge role in supporting the efficiency, integrity and safety of the pharma supply chain globally. I would encourage all companies to examine how Bonafi can help automate and update the laborious, time consuming and costly exercise in good distribution practice. I wish Katarina and all her team every success in the months and years ahead as they roll out this marvellous and user-friendly initiative.”

Anne Lanigan, Divisional Manager, Technology and Services, Enterprise Ireland said: “Bonafi is a regtech high potential start-up bringing innovation and adaptability to the critical area of compliance in the pharmaceutical industry. Enterprise Ireland is proud to support the company on its scaling journey and I’d like to congratulate the team on their significant achievements to date. Under the leadership of CEO and Founder Katarina Antill, we are confident that Bonafi can go from strength-to-strength and make its mark offering a highly innovative deep-tech solution to the pharma sector globally.

Ends

IMG_9198

Bonafi’s New Office in Trim – A New Home for Growth and Innovation

Bonafi Office in Trim

We are thrilled to announce that Bonafi has recently moved into our new office in Trim. After months of planning and preparation, we have finally settled into our new space, and we couldn’t be more excited to share this news with our future customers, partners, and friends.

Our office is located in the historic town of Trim, Co. Meath, with easy access to local amenities and transportation links. The space has been designed with our team’s needs in mind, providing a modern and collaborative environment that encourages creativity and innovation.
Moving to a new office is always an exciting milestone for any business, and for Bonafi, it represents a significant step forward in our growth journey. We have come a long way since our inception.

Our office will enable us to deliver exceptional service to our future customers while providing us with the space and resources we need to expand our product offerings and reach new markets. We are confident that this move will help us build a strong foundation for future growth and success.

We would like to take this opportunity to thank all our partners and employees for their support and dedication throughout this transition. We are thrilled to welcome you to our new home and look forward to continuing our journey together.

Follow us on social media for more updates on our journey and exciting developments.

Thank you for your continued support, and here’s to a bright future for Bonafi.

National Startup Awards 2021

Bonafi takes Bronze in the National Startup Awards 2021!

Bonafi takes Bronze in the National Startup Awards 2021!

We are so proud to have won Bronze in the National Startup Awards 2021 in the best Medtech Startup Category.

The recognition goes a long way and it is very rewarding after all the hard work the entire team has put in. Starting a business and building new technology, is most certainly not the easiest path forward. But these types of acknowledgments make all the difference.

A big thank you to everyone in the Bonafi team that has supported us along the way and worked so hard on this.  Also a bit thank you to the National Startup Awards 2021 and all the sponsors that make the Irish Startup Ecosystem glow!

Screenshot 2020-10-19 at 13.37.41

Featured in Thinkbusiness.ie

Bonafi Featured in Thinkbusiness.ie

Glad to be the Editor’s Pick in this morning’s Business Planning section of Thinkbusiness.ie.

You can find a link to the article on the right.

 

NEWS

FIND US

Bonafi Limited

Suite B119
The LINC Centre
Blanchardstown Road North
Dublin 15, Ireland

Email: info@bonafi.ie

GET IN TOUCH

Screenshot 2020-10-15 at 22.02.13

Interview with DublinBIC

Talk with Dublin BIC

I was invited by Dublin BIC to talk about Bonafi, patient safety, and falsified medicines. Our conversation sheds light on why it is important to know who your pharma customers and suppliers are, and how patients could be put at risk if the due diligence is not carried out.  We also discussed the potential risks that have emerged as a result of COVID-19. 

Share our News!

LinkedIn
Twitter
Facebook
WhatsApp

NEWS

FIND US

Bonafi Limited

Suite B119
The LINC Centre
Blanchardstown Road North
Dublin 15, Ireland

Email: info@bonafi.ie

GET IN TOUCH

A picture of the InterTradeIreland Seedcorn Investor Readiness competition 2020 logo, with the text "Regional Finalist - Bonafi" in the upper right corner.

Seedcorn Competition

Regional Finalist in the Seedcorn Competition!

A picture of the InterTradeIreland Seedcorn Investor Readiness competition 2020 logo, with the text "Regional Finalist - Bonafi" in the upper right corner.

Really glad to announce that Bonafi is one of the regional finalists for Dublin as a start-up in the biggest business competition across Ireland and Northern Ireland for an innovative new start and early-stage businesses in any sector.

Bonafi will go on to compete in the Seedcorn Final and the winner is announced on the 26th November. Stay tuned and wish us good luck!

NEWS

FIND US

Bonafi Limited

Suite B119
The LINC Centre
Blanchardstown Road North
Dublin 15, Ireland

Email: info@bonafi.ie

GET IN TOUCH

TGramova

Interview with our Developer on International Women’s Day

We are celebrating our female software developers at Bonafi!

Our spotlight is on Tsvetina Gramova. 

What it is that you do and what a typical day for you is like?
I am a software developer with focus on backend development and DevOps services. I’m a pretty organized person. I like to plan my work in advance (when possible) and usually, a typical workday for me runs in the form of a series of small tasks that solve bigger problems.

What made you decide to go into computer science?
I’ve always loved solving problems and learning new things. I am pleased when I can understand, plan and divide the problem into smaller parts. I also have an affinity to arrange things so that everything works in the most effective manner. Initially, programming for me was experimental when I still didn’t know what I wanted to do and was trying to find my calling. Almost immediately, however, it turned out to be the most natural thing to invest my efforts and energy into, because it became not just my job, but also my passion.

Have you ever been in a situation where you felt your gender has affected the way that they are perceived or treated? How did you handle it?
I personally, have never experienced a negative situation for being a female programmer in my few years of working experience.
I have always met understanding and support from my colleagues. Perhaps, somewhere around the world, there is still a particular attitude towards women programmers, simply because for a long time this job has been perceived as “masculine.” But the tendency is for women to become more motivated and to prove that they are in no way inferior to their male counterparts.

What do you think is the best part of working in the tech industry?
For me working in the tech industry is very exciting, challenging and interesting. This is mainly due to the dynamics and pace at which the sector is evolving. In order to keep up with new trends and technologies, you need to constantly read and learn new things, maintaining your desire to develop, which in turn guarantees you a fascinating job.

Do you notice a lack of women in technology? If so, why do you think that’s the case?
As I said before, perhaps the assumption that the technology sector is predominantly for men is still affecting women’s thinking and they worry that they will not be taken seriously and will be underestimated. But in fact, more and more women take the courage and shift towards technology. In one of the previous tech companies I worked for, the percentage of women to men was almost 50:50. There were women programmers as well as women in other technical positions – QAs, PMs, UX designers, business analysts and so on. 

What advice would you give to a woman considering a career in the tech industry?
I certainly believe that women are no less capable than men to write software and develop great technologies that solve important problems. Even, maybe in some cases, we are more motivated and try harder to prove that we are also good at our job. Therefore, I would advise all women considering a career in the tech industry not to be afraid to show themselves and to believe that it is important not what gender you are, but how ambitious, confident and decisive you are.

Did you know…?

  1. Female Tech positions are growing 238% faster than their male counterparts.
  2. While 56% of Women in Tech leave their jobs at midlevel positions, 22% of these women do so to start their own business
  3. 85% of Women in Tech say that they love their job.
  4. 20%  of all tech startups across the world are founded by women.
  5. 17% of the 1.4 million people in the E.U studying Tech are Women
  6. From 2000 to 2015 there has been a 21% increase in 1st-year college students majoring in Computer Science

Sources:

Visualcapitalist.com

Mavericktester.com

NEWS

FIND US

Bonafi Limited

Suite B119
The LINC Centre
Blanchardstown Road North
Dublin 15, Ireland

Email: info@bonafi.ie

GET IN TOUCH

Bonafi in Irish Times

Bonafi is in the NEWS!

Bonafi featured in Irish Times!

Bonafi in Irish Times

I was delighted to be featured in the Irish Times Innovation column today. You can find the link to the interview below.

 

NEWS

FIND US

Bonafi Limited

Suite B119
The LINC Centre
Blanchardstown Road North
Dublin 15, Ireland

Email: info@bonafi.ie

GET IN TOUCH