H&A Scientific, Inc

H&A Scientific has been creating software solutions for pharmaceutical, medical, and laboratory organizations since 1992. The company specializes in stability study management software, most notably its flagship SLIM (Stability Laboratory Information Management) platform, designed to help organizations streamline compliance with FDA 21 CFR requirements and Good Automated Manufacturing Practice (GAMP) guidelines. H&A Scientific serves hundreds of top pharmaceutical and life sciences companies worldwide, providing turn-key solutions that simplify installation, validation, training, maintenance, and day-to-day laboratory operations.

H&A Scientific's core mission is to deliver stable, simple, and reliable stability study management software backed by best-in-class, US-based customer support. Their team of experienced expert scientists is known for rapid response times and superior technical assistance, ensuring agency-friendly, 21 CFR Part 11 compliant solutions that improve regulatory submission success rates.

Core Products

• SLIM (Stability LIMS): A commercial off-the-shelf solution for complete management of drug stability programs, designed as a fully validated stability laboratory database manager.
• SLIM Stat (Stability Statistical Analysis): Intuitive shelf-life projection software developed specifically to determine the shelf-life of drug products placed on stability studies.
• SLIM Report Generator (Stability Reporting): Validated and customizable report generation software enabling seamless creation of stability reports in a format ready for FDA submission.
• SIM: An additional software module available within the H&A Scientific product suite to support laboratory information management needs.

Key Capabilities and Features

• Full compliance with FDA 21 CFR Part 11 requirements and GAMP guidelines.
• Turn-key solution design that simplifies installation, validation, training, and ongoing maintenance.
• Dedicated to continuous improvement to maintain alignment with evolving FDA and GAMP requirements.
• Accurate results that support successful regulatory submissions for pharmaceutical and medical companies.
• Designed for organizations of any size, from smaller labs to large multinational pharmaceutical companies.

Services

• Custom Development: Specializing in SQL and Oracle database management programs for pharmaceutical, medical, and laboratory companies, with full support from planning and development through testing and validation.
• Validation and Training: Comprehensive validation services and hands-on training to ensure compliant and effective use of laboratory software systems.
• Data Import and Export: Services to facilitate seamless migration and integration of laboratory data.
• Calibration: Calibration services offered as part of the broader laboratory support portfolio.

Compliance, Support, and Deployment

• All products are fully validated and 21 CFR Part 11 compliant, making them suitable for regulated pharmaceutical and life sciences environments.
• US-based support team composed of experienced expert scientists providing rapid response times and superior technical assistance.
• Ongoing software releases and updates to keep customers current with regulatory and technical requirements.
• Free virtual demonstrations available for prospective customers to evaluate the platform before purchase.
• Proven track record working with hundreds of the world's leading pharmaceutical companies.

H&A Scientific combines decades of laboratory software expertise with a strong commitment to regulatory compliance and customer success, making it a trusted partner for pharmaceutical, medical, and laboratory organizations seeking reliable stability LIMS and custom database solutions.