We Help, You Succeed in biopharma production through expert consultation for digital transformation & advanced manufacturing.
We Help, You Succeed in biopharma production through expert consultation for digital transformation & advanced manufacturing.
The biopharma production landscape is evolving rapidly. Strict regulations, increasing production complexity, and the drive for operational excellence necessitate a robust, digital-first approach to manufacturing. SVASTEC specializes in guiding pharmaceutical and biotech clients through the selection, implementation, and validation of Manufacturing Execution Systems (MES) to address these challenges and achieve peak performance through digital transformation.
With decades of collective experience in life sciences and project management, our consultants understand the unique GxP and validation requirements of the biopharma production industry. We assist you in achieving success through digital transformation by replacing error-prone, paper-based processes, such as Batch Manufacturing Records, with a digital, real-time Manufacturing Execution System (MES) that ensures compliance, enhances product quality, and boosts efficiency.
We offer independent, tailor-made advice and comprehensive support across the entire MES lifecycle, specifically tailored for biopharma production and digital transformation needs.
Process Analysis & Consulting: Our in-depth gap analyses help identify areas for improvement, defining a strategic blueprint for the next-gen Manufacturing Execution Systems (MES) adoption.
MES Selection & Implementation: We provide guidance in choosing the right MES solution and managing the entire implementation project, from URS preparation to go-live and hyper-care support, ensuring a smooth transition for biopharma production environments.
Validation & Compliance: Our specialists are well-versed in GAMP 5 and 21 CFR Part 11 requirements, minimizing validation effort while ensuring a compliant system for your digital transformation goals.
System Integration: We possess expertise in aligning and harmonizing all business processes, including integration with ERP (SAP), LIMS, QMS, and automation systems, essential for efficient biopharma production.
Master Batch Record (MBR) Design: Our team efficiently designs and develops electronic MBRs, ensuring all production steps are controlled, monitored, and documented digitally, which is vital for modern MES implementation.
Change Management & Support: We manage organizational transformation and provide ongoing support and maintenance to ensure sustained success in your digital transformation journey.
Don't let legacy systems hinder your path to operational excellence in biopharma production. Book a Free Consultation with our experts today to discuss your project requirements and agree on a customized strategy for your digital transformation, including the implementation of Manufacturing Execution Systems.