CSV For Pharmacovigilance Systems
Dedication in pharmacovigilance.
To provide optimized CSV solutions.
At Biomapas, we understand the importance of compliance in the GxP regulated environment, particularly for pharmacovigilance systems. Our expert team is dedicated to helping you validate computerized systems that impact product quality, patient safety, and data integrity, adhering to stringent national and international regulations and guidelines.
The right combination of experience and technical knowhow.
Why Choose Biomapas for Your Pharmacovigilance System Validation?
1. In-depth Knowledge of Regulations & Guidelines
Our team is well-versed in the applicable regulations and guidelines, including 21 CFR Part 11, EU GMP Annex 11, and GAMP 5. We also follow a risk-based approach recommended by competent authorities to focus validation activities on high-risk areas, reducing validation efforts while improving quality.
2. Expertise in Pharmacovigilance Systems
Our validation and pharmacovigilance experts develop and implement system validation activities based on a deep understanding of PV operations and industry best practices. Over the years, we have successfully validated and implemented multiple complex PV systems, including major safety databases, for various international pharma companies in the EU regions.
3. Dedicated Project Management
In our commitment to serve our customers, we assign a dedicated project manager to each client. This individual plays a pivotal role in meeting business and compliance objectives, regularly updating stakeholders about project progress. They are also in charge of cost control and proactive risk management, ensuring project goals are met effectively and efficiently. The project manager stands as a crucial link between the client, the project, and our internal team, driving the project from start to finish.
Case Study
As a real-world example, explore our case study of a Pharmacovigilance system validation we recently tackled. We were approached by a mid-sized pharma company in the European Union to validate a cloud-based safety database.
Choose Biomapas for Compliant and Cost-effective Pharmacovigilance System Validation
Our solutions allow you to implement complex GxP pharmacovigilance systems in a compliant and cost-effective manner, ensuring your organization’s highest quality and safety standards. Our Comprehensive Validation Services include:
- Performing system assessment against regulatory requirements.
- Conducting risk assessment of a computerized system.
- Preparing validation documentation.
- Executing validation scripts.
- Maintaining the validated state of the system throughout its lifecycle.
Partner with Biomapas today and experience the difference between working with a devoted, experienced team that adapts to emerging situations and works closely with you and third parties to achieve your compliance goals.
Pharmacovigilance Insights
Comprehensive Guide to Medical Information and Pharmacovigilance Integration
Discover how integrated Medical Information and Pharmacovigilance workflows enhance compliance, improve safety, and streamline regulatory processes.
Biomapas Insights: From Hope to Global Impact – How Elpida Accelerated Gene Therapy for Rare Diseases
In this Biomapas Insights episode, Martijn van de Leur, Chief Commercial Officer, speaks with Terry Pirovolakis, CEO of Elpida Therapeutics, the organisation that grew out of the CureSPG50 advocacy movement. Together, they explore how a parent-led mission to help...
Choosing the Right QPPV Partner for EU and Global Compliance
Explore the essential functions of a QPPV and discover how to choose the right partner for pharmacovigilance.
Contact Us
Contact us to learn about how we can enhance your clinical development, accelerate your path to Market Authorisation, and ensure compliance with local and global Post-Marketing requirements.
