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Experts in digital transformation and consulting
 for the Pharmaceutical and Biotech Industries

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Validation, qualification, and regulatory compliance

for your digital transformation

At Ambit BST, we’ve been leading digital transformation in the Pharma & Biotech sector for over two decades. Our team of experts specializes in computerized system validation and regulatory consulting, ensuring compliance and improving operational efficiency across laboratories, manufacturing facilities, and research centers.

Digital transformation in GxP environments is key to maintaining competitiveness and ensuring quality in the production of pharmaceutical and biotech products. At Ambit BST, we design end-to-end solutions covering everything from validation and qualification of IT systems to auditing and consulting in GMP, GCP, GLP, GDP, and GVP standards—including the implementation of data integrity strategies (ALCOA+).

Our approach focuses on tailoring emerging technologies to the sector’s specific needs—validating all types of systems (ERPs, LIMS, MES, SCADA, and more) and ensuring that each process meets the most demanding regulatory requirements. This way, we help clients optimize their operations and reinforce a culture of quality and efficiency.

With our Products and Consulting Services, we’ll accompany you on your journey toward operational excellence. Explore the solutions we’ve prepared for you.

We accompany you during all stages of your pharmaceutical and biotechnological work process.

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Our integrated approach to digital transformation and risk management turns every challenge into an opportunityto achieve operational excellence in the Pharma & Biotech sector.

Products

PRODUCTS

ManVa

Validation status maintenance for SaaS systems—essential for managing the pharmaceutical supply chain.

CalCroma

Digital automation of calculation configuration for chromatographic systems—enhancing analytical method accuracy.

TraceDesk

Serialization and traceability optimization in supply chain management, facilitating the transition to Pharma 4.0.

Digital Validation

100% paperless digital system validation, ensuring traceability and efficiency in every process.

PRaaS

Specialized periodic review service to ensure ongoing quality and regulatory compliance of your computerized systems.

CONSULTING SERVICES

CONSULTING SERVICES

Comprehensive service for implementation, project management, and ongoing maintenance of validated computerized systems.

We ensure the proper functioning and regulatory compliance of your equipment and facilities, resolving deviations and securing optimal maintenance.

Internal audits, vendor audits, and targeted assessments of regulatory requirements (Data Integrity, Annex 11, 21 CFR Part 11, etc.), supporting quality operations.

Through our DIRA methodology, we standardize ALCOA+ data integrity principles and ensure full compliance with critical regulations.

Our Partners

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