Solutions for Pharmaceuticals & Medical Devices

Pharmaceutical and medical device manufacturers have been applying software solutions and associated control systems to their processes to reduce costs and waste, improve product quality and consistency, accelerate new product introductions and eliminate process variability. As an extension to these efforts, these manufacturing companies are evaluating specific plant operations to improve safety, address environmental impact, document, verify and track design changes, process modifications and complete product information. In addition, a large number of regulatory and compliance requirements are levied throughout the industry. Because of these mandates and consequences of not complying, companies in this industry will continue to evaluate and implement the latest technologies and solutions. Industry Challenges: · Extensive standards and compliance - 21 CFR Part 11 rule for Electronic Records & Electronic Signatures - ISO9001 / EN46001 and other requirements - and other requirements · New FDA QSR and other quality regulations · High administrative and insurance overhead · Legal threats and impacts Empresa provides answers to these challenges -- and more. · Enabling 21 CFR Part 11 compliance via collaborative document management · Proactive analysis and root-cause isolation of system failures · Compliance tracking for all parts and assemblies · Automatic verification of as-built to engineering specifications · Collaborative communication of failure information with suppliers · Complete traceability reporting for regulatory compliance · Measurement and delivery for Six-Sigma metrics, analyses, and controls