🔹 Connexo Service & Support – Featured Session at HLS 2025 Korea

🔹 Novatek Solutions in Action – EM× MAS-100™ & CV

🔹 Daewoo Pharmaceutical – FDA Warning Letter for Aseptic Control Deficiencies

🔹 FDA Warning Letter – Glenmark Pharmaceuticals (India)

🔹 FDA Approves Qfitlia for Hemophilia A & B

1. Connexo Service & Support – Featured Session at HLS 2025 Korea

Connexo is proud to participate as a key sponsor and featured speaker at the Honeywell Life Sciences World Tour 2025 Korea, taking place on August 21, 2025, at the Enfold Hotel, Cheongju, South Korea.

In our session titled “Connexo Service & Support,” we will share our experience in implementing TrackWise-based quality management systems, with a focus on practical methods for visualizing and intuitively analyzing quality data in the pharmaceutical and biotech industries.

This approach aims to provide hands-on insights for Korean life sciences companies seeking to advance their digital quality systems.

The HLS 2025 Korea event will also bring together TrackWise users and various industry stakeholders to explore the most pressing challenges and future directions in life sciences.

We sincerely invite you to join us and help make this event even more meaningful through your participation and engagement.

🗓️ Event Information
Date: Thursday, August 21, 2025
Venue: Enfold Hotel, Cheongju, South Korea

The event will run from 9:00 AM to 1:10 PM, featuring a series of presentations from experts and industry leaders, centered on the following key agenda topics:

Agenda Highlights:

·        Building structured quality and recall management systems

·        Supporting decision-making and process efficiency with AI

·        Enhancing operational performance through digital transformation

·        Managing and mitigating risks across the manufacturing value chain

·        Accelerating market readiness with high-quality products

·        Innovations in TrackWise and TrackWise Digital

Connexo will speak from 12:00 PM – 12:20 PM, presenting “Connexo Services and Support” to deliver actionable insights rooted in real-world experience.

🔗 Register for the event

2. Novatek Solutions in Action – EM× MAS-100™ & CV

📊 Novatek Environmental Monitoring × MAS-100™
✨ Delivering Data Integrity and Efficiency in Air Sampling

Environmental monitoring is a cornerstone of quality control in GMP environments. Novatek’s Environmental Monitoring (EM) system is designed to digitally capture and manage diverse environmental data, including air, surface, and water sampling. Through integration with MAS-100™ instruments, airborne microbial data can be collected and monitored in real time.

This system schedules sampling points automatically based on user-defined sampling plans and triggers immediate alerts when results exceed defined limits. Recurrent deviations are linked to CAPA workflows to ensure a systematic response to risks.

🔹 Case Study

A global pharmaceutical company adopted the Novatek EM system integrated with MAS-100™ NT to overcome limitations of their manual air sampling process. The result: enhanced data integrity, automated reporting, audit trail capabilities, and over 40% time reduction compared to legacy methods.

🔹 Key Benefits

·        Automated protocol transmission and result capture

·        Multi-matrix support for air/surface/water data and location-based trend analysis

·        Alerts and deviation reason tracking

·        Full compliance with 21 CFR Part 11 and EU Annex 11

·        Strengthened regulatory readiness with tamper-proof audit trails

Environmental monitoring now demands a structured, digital-first approach. Novatek EM, integrated with MAS-100™, offers a comprehensive solution aligned with global regulations.

🧼 Novatek Cleaning Validation Management – Digitized Lifecycle in Practice

Cleaning validation (CV) is essential to prevent cross-contamination and ensure GMP compliance. Yet many pharmaceutical manufacturers still struggle with manual document management and validation tracking.

🔹 Case Summary & Outcomes

A biopharmaceutical company managed CV reviews and retesting schedules manually using spreadsheets. Issues like missing records, overlooked retest dates, and incomplete justifications led to repeated audit risks.

By implementing Novatek's Cleaning Validation Lifecycle Management system, they achieved the following transformational improvements:

🔹 Key Improvements

·        Integrated management of CV plans, SOPs, analytical results, and qualification history

·        Automated retest alerts and risk-based scheduling

·        Instant audit-ready reports (by equipment, product, or process)

·        Full 21 CFR Part 11 compliance with approval workflows and e-signatures

·        Complete audit trail logging for regulatory assurance

Manual tracking no longer meets regulatory expectations. Novatek’s CV solution ensures consistency and compliance across the cleaning validation lifecycle in GMP environments.

3. Daewoo Pharmaceutical – FDA Warning Letter for Aseptic Control Deficiencies

On July 2, 2025, the U.S. FDA issued a CGMP Warning Letter to Daewoo Pharmaceutical Co., Ltd. following a January inspection (January 15–19) of its Busan facility.

Key findings:

·        Inadequate unidirectional airflow and insufficient control of ISO 5 environments

·        Unhygienic behavior in aseptic areas, including exposed skin on arms and neck, and use of non-sterile tape

·        Incomplete smoke studies and absence of environmental monitoring for personnel

·        Media fill simulations conducted under non-representative conditions

The FDA requested a comprehensive remediation plan, including:

·        Redesign and improvement of cleanroom layout and operations

·        Repeat verification of airflow and media fill processes

·        Enhanced personnel hygiene training and introduction of monitoring systems

🔗 Read the full FDA letter

4. FDA Warning Letter – Glenmark Pharmaceuticals (India)

On July 11, 2025, the FDA issued a CGMP Warning Letter to Glenmark Pharmaceuticals Ltd. following significant manufacturing violations at its facility in Pithampur, India.

Key Findings:

·        Failure to properly investigate OOS results

·        Inadequate process validation across batches

·        Repeat violations similar to past observations at other Glenmark sites

The FDA has demanded systemic remediation, effective CAPAs, and prior notice before resuming U.S. shipments.

🔗 Read the FDA letter

5. FDA Approves Qfitlia for Hemophilia A & B

On March 28, 2025, the FDA approved Qfitlia (fitusiran) as a prophylactic treatment for patients aged 12 and older with hemophilia A or B, with or without inhibitors.

Key highlights:

·        Subcutaneous injection every two months

·        RNA interference mechanism targeting antithrombin to promote clotting

·        ~71–73% reduction in annual bleeding rates in clinical trials

⚠️ Boxed warnings include risks of thrombosis, liver toxicity, and gallbladder disease.
Monthly liver monitoring is required for six months after treatment initiation.

Qfitlia offers a new preventive option for both adult and pediatric patients, especially those with limited alternatives

🔗 View the FDA press release

📩 Inquiries & Demo Requests:

[email protected] / www.connexo.io