Quality Assurance
Our quality assurance services encompass comprehensive program development, the creation of robust policies and procedures, and thorough audits and assessments. We develop tailored programs that meet industry standards, design policies and procedures to ensure consistent quality and regulatory compliance, and conduct detailed audits and assessments to identify areas for improvement and ensure ongoing excellence in operations. Through these services, we help companies maintain high standards of quality and operational efficiency.
Smartsheet Development
We offer simple, compliant, and cost-effective data
solutions for regulated industries.
Fresh Approach
Managing historical quality records in regulated industries poses significant challenges. Records must be searchable for at least two years, yet importing old data into new systems can be complex and counterproductive. Traditional data warehouses are often expensive and excessive, while Excel flat files lack compliance and usability. To address these issues, we introduce the Smart GMP Archive.
Lightweight GxP Data Solutions
Simple, searchable, and reportable solutions that bridge the gap between cumbersome spreadsheets and expensive commercial software. 21 CFR Part 11 compliant.
IT Strategy and Computer Systems Validation
Offering IT Systems and Validation services, we encompass a comprehensive approach to system selection, implementation, validation, and data migration. We guide companies through selecting the most suitable systems tailored to their specific needs, ensuring seamless integration and compliance. Our meticulous implementation and validation processes guarantee that systems operate efficiently and meet regulatory standards. Additionally, our expertise in data migration ensures that vital information is accurately and securely transferred, minimizing disruption and maximizing operational continuity.
Vendor Management
With 20+ years in the Life Sciences industry, we have established relationships with numerous GxP vendors. We help clients select, qualify and manage critical service providers.
Vendor Management
With 20+ years in the Life Sciences industry, we have established relationships with numerous GxP vendors. We help clients select, qualify and manage critical service providers.