Pharmaceutical
With one of the most challenging and stringent regulatory environments of any industry, pharmaceutical manufacturing requires meticulous adherence to quality standards and process controls.
You need more than an IT solution. You need a partner with industry experience; one who understands the specific requirements of your business and can help you comply with the ever-changing FDA and international regulations while becoming more efficient. Hyla Soft can help.
From basic data collection and quality control systems to full blown 21 CFR Part 11 compliant MES systems with Electronic Batch Records, we have the industry experience and technological expertise to help you improve your business. Some key benefits of our services include:
- Reduced cost and increased efficiency through the ability to create, approve, manage, execute, and review Batch Records electronically with fully 21 CFR Part 11 compliant Electronic Batch Record (eBR) Systems
- Improved quality and fewer deviations by reducing/eliminating inherent human errors such as calculation errors, illegible entries, incorrect dates, and missing signatures
- Improved transparency and data tracking throughout the entire production process allowing for easier exposure of critical process information including batch-to-batch comparisons, real-time reporting, and genealogy information
- Improved process safety and reliability with automated label and safety placard generation
- Increased efficiency through rapid access to real-time data allowing for process monitoring and planning that can reduce the number of lost batches
Hyla Soft is dedicated to creating lasting partnerships with our clients. By working together, we can identify the most effective ways to apply our technology solutions and industry know-how to your specific requirements. Let us put our experience to work to help your business succeed and thrive in the challenging Pharmaceutical Manufacturing Industry.
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