THE BUSINESS NEED
When they decided to implement a QMS in pharmaceuticals, Huvepharma faced unique compliance and quality process challenges. Developing and implementing standardized quality processes across many global sites was difficult, as processes needed to meet each location’s specific governmental and industry regulations.
In addition, Huvepharma’s “paper quality culture” made staff reluctant to move away from tried-and-true manual processes to a compliance management system, and multiple languages complicated quality processes and made training across all production sites a tedious task.
The company was experiencing rapid growth, and its quality team understood that to provide the accurate analytics that would empower data-driven decisions, it must standardize its quality processes and documentation across the entire product lifecycle. The team also wanted to reduce non-conformance, improve supplier quality, work with suppliers on corrective actions, and reduce corrective action closure time.
Mina Gavrilova
Quality Manager, Huvepharma
“One of our main challenges was that we needed a multi-site implementation. Most of the employees at our French, Bulgarian and Italian sites didn't speak English, so this was a big challenge. Another challenge was the wide range of regulations and standards to comply with due to the different site’s locations and different countries.”
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Today, Huvepharma counts on ETQ Reliance to comply with regulations across the globe, including regulations set forth by the European Union Good Manufacturing Practices (EU GMP), the United States Department of Agriculture (USDA), and the United States Food and Drug Administration (US FDA).
The company kicked off the use of ETQ Reliance by implementing change management, events, and CAPA modules across its sites in Bulgaria, Italy, and the US. Then, Huvepharma went live with document control and complaints management before implementing events, CAPA and change control for its French sites. Most recently, Huvepharma has migrated paper documents — including SOPs, policies, guidelines, templates, protocols, and reports — from their sites in Bulgaria, Italy, the US, and Belgium into ETQ Reliance.
Working with ETQ Reliance has provided Huvepharma with harmonization across all its entities, ensuring compliance for every international site. Able to use ETQ right out of the box with minimal customization, Huvepharma’s quality team enjoys global oversight of quality compliance and process improvements, allowing them to maximize efficient use of the team’s resources.
Huvepharma has more than half a century of expertise in fermenting and manufacturing human and animal health and nutritional products. With in-house capabilities for the complete production cycle from strain to shelf, the company is one of the top ten veterinary pharmaceutical companies operating around the world today.
Terms and conditions
About Huvepharma: Huvepharma is a fast-growing global pharma company (in terms of sales growth), focusing on developing, manufacturing, and marketing animal and human health and nutraceutical products. Its key strengths lie in large-scale fermentation and technical expertise developed over half a century at its European manufacturing sites. With the joint venture partnership, Huve Nutraceuticals brings expertise in micro-organisms to produce ultra-high quality, very competitive algal-based ingredients and finished products for human, pet, and aquaculture nutrition applications. For more information, visit https://www.huvepharma.com.
About ETQ: ETQ, part of Hexagon, is the leading provider of quality, EHS and compliance management SaaS software, trusted by the world’s strongest brands. More than 600 customers globally, spanning industries such as pharmaceuticals, electronics, heavy industry, food and beverage, and medical devices, benefit from ETQ to secure positive brand reputations, enable higher levels of customer loyalty and enhance profitability. ETQ Reliance offers built-in best practices and powerful flexibility to drive business excellence through quality. Only ETQ lets customers configure industry-proven quality processes to their unique needs and business vision. ETQ was founded in 1992 and has main offices located in the U.S. and Europe. To learn more about ETQ and its various product offerings, visit www.etq.com.
Hexagon is a global leader in digital reality solutions. Learn more about Hexagon (Nasdaq Stockholm: HEXA B) at hexagon.com and follow us@HexagonAB.
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CASE STUDY
Standardization across disparate systems
Harmonization using one QMS for 12k users
Out-of box-implementation enabled rapid deployment
QUALITY JOURNEY
Headquartered in Sofia, Bulgaria, Huvepharma focuses on bringing human health and animal health and nutrition products to market. The company has gained a track record as a fast-growing global pharmaceutical company in the past ten years. With independent manufacturing units in Bulgaria, Italy, France, and the US — and over 90 affiliates and offices worldwide — Huvepharma’s ambitious growth demanded a strong focus on quality and implementing a global quality management system. Huvepharma’s quality team realized it needed compliance management software to ensure the delivery of safe, quality products to its customers.
How Huvepharma Maintains Quality and Regulatory Compliance to Support Rapid Global Growth.
Mina Gavrilova
Quality Manager, Huvepharma
ETQ Reliance was selected because it was flexible, highly configurable, easy to modify in house — and it was FDA and EU compliant, giving audit trail electronic signatures traceability. It had very good connectivity between modules, records and processes. Also, its intuitive interface looks similar across modules — very important for a multi-site company such as ours.
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FILLING
THE GAP
With early wins in document control, complaints management, change control and CAPA, Huvepharma plans to continue using ETQ Reliance to standardize and streamline the company’s quality management processes. The quality team has plans to implement training management and supplier qualification modules.
LOOKING FORWARD
Mina Gavrilova
Quality Manager, Huvepharma
The post-implementation benefits are that we accelerated compliance and increased efficiency. It sped up the processes. And we achieved very big improvements in our customer complaints process across all sites, so sites stay in compliance.
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