With decades of industry & technical expertise combined with a forward-thinking approach, we bridge the gap between compliance and innovation.
We partner with leading life sciences companies to transform their Quality Management Systems, maximize their technology ROI, and empower them to thrive in the digital age.
Digital Quality Management for Life Sciences
Evaluation, gap analysis, strategy, implementation, and support of digital QMS platforms tailored to life sciences regulations and workflows
AI Agents for Quality Operations
Design and deployment of AI agents to automate manual and time-consuming work
Conducts internal mock audits to prepare for official inspections.
Creation, review, and editing of technical documents and Standard Operating Procedures (SOPs).
Analyzes quality records to identify trends, predict risks, and recommend proactive actions.
Generates training materials and quizzes to ensure employee understanding of procedures and compliance.
Guides technicians on procedures, ensures GLP/GMP compliance, and flags deviations in real time.
An agent that assists with Computer System Validation (CSV) and Computer Software Assurance (CSA) documentation and processes.
Automates and assists with the review of manufacturing batch records for accuracy and completeness.
Monitors regulatory websites and industry news to interpret new guidance and its impact on the company's QMS.
A bespoke solution designed to address your unique and specific use-case not covered by the other agents.
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