NuLEAP Technologies and Venostic Solutions announced a new strategic partnership to support Indian pharmaceutical companies’ needs for computer systems validation and IT compliance as per international global requirements.
Under the terms of the collaboration, NuLEAP and Venostic will provide a comprehensive set of services that will enable Indian pharma companies to develop regulatory processes for their computer systems validation and IT policies to ensure data integrity as per international norms. Several regulatory actions in recent months are driving the requirement for an in-depth review and solutions to meet international standards for data integrity and IT policies. NuLEAP’s local presence combined with Venostic’s international team will provide Indian organisations with the tools and services to effectively streamline their infrastructure, work practices and validation policies to meet international IT regulatory requirements that have been the subject of much attention in recent times.
For over 20 years David Stokes and his team members at Venostic have contributed to the development of US FDA, EU and PIC/S guidance and to the development of the GAMP guide and associated ISPE / GAMP Good Practice Guides, including:
- GAMP 5: A risk-based approach to compliant GxP computerised systems
- A risk-based approach to electronic records and signatures
- A risk-based approach to testing of GxP Systems (second edition)
- Electronic Data Archiving
- Global Information Systems Control and Compliance
- IT Infrastructure Control and Compliance
- Manufacturing Execution Systems – A Strategic and Program Management Approach
- Biopharmaceutical Manufacturing Facilities (Second Edition)
With more than 30 years consulting experience, Venostic’s consultants have supported clients in North, Latin and South America, Europe and the Middle East, Asia and Africa to achieve and maintain a state of IT regulatory compliance. NuLEAP and Venostic will jointly support the new solution in the field. Venostic will bring its international credibility and expertise to the partnership and NuLEAP, based in Mumbai, India, will deliver the end-to-end technological focus combined with on-the-ground market knowledge. This solution will offer professional advice as well as on-site support for development and training required for international levels of compliance, standardisation of computer systems validation and data management processes.
Louis Coutinho, Chief Executive Officer, NuLEAP Technologies stated, “There is an established customer base of pharma companies in India, who have an aggressive presence in the international market. Compliant enterprise electronic solutions are key to enable them to gain and sustain FDA approval.”
EP News Bureau – Mumbai