Clients that have directly benefited from working with our team:
Life Sciences and Healthcare
Meeting the challenges of FDA-regulated facilities
The Life Sciences Industry continues to struggle with increasingly complex challenges ranging from regulatory and compliance pressures from FDA and Sarbanes-Oxley, global competition, as well as mergers an acquisitions. With shorter periods of drug exclusivity, the increase of generic competition and the cost of research and development (R&D), it is more important than ever to deliver sustainable and enhanced shareholder value against higher market expectations. Mitigating risks and delivering products based on the ultimate quality standards is essential. Validation of all information and business processes are key and therefore it is important to manage all critical assets and services according to all these requirements.
How Aquitas Solutions can help:
- Our Maximo consultants can help you navigate through strict operational, legal, and regulatory guidelines such as FDA 21CFR part 11 and ISO 9001 that must be adhered to for environmental, safety, and health issues.
- Aquitas consultants can provide extensive configuration and process management capabilities that will enable your organization to effectively manage real time changes to business processes, applications, data models, reports, and integration.
- Improve operational excellence and performance of critical production (line) assets through advanced maintenance and calibration
- Implement Maximo to reduce costs and achieve faster Return on Asset (ROA) by consolidation of software applications relevant for managing all assets and their usage, performance and availability. This includes Maximo Mobile, Calibration, HS&E, Scheduler, Spatial, etc.
- Create and implement data governance solutions to maintain accurate, actionable information
