Pharmaceutical

The pharmaceutical industry encompasses a diverse group of markets, including research-based, generic, parenterals, and over-the-counter drugs. While mostly dominated by large, Fortune 500 companies, the pharmaceutical industry also includes smaller start-up and specialty organizations.

Calibration, maintenance, and validation play a part in all aspects of the drug-making process, including:

• Analytical instrumentation in drug development
• Process instrumentation in pilot plants
• Process and laboratory instrumentation in drug manufacturing
• Equipment and systems in drug manufacturing
• Quality control in virtually every department

Pharmaceutical companies must constantly be cognizant of the increasingly rigorous requirements imposed by the FDA and other international regulatory agencies, as well as respond to constant pressures to reduce costs and improve productivity. Ultimately, the software for managing assets that pharmaceutical organizations implement must be compliant and flexible.

As the Quality Systems Inspection Technique becomes the standard for FDA audits, pharmaceutical companies are strongly encouraged to take a good look at the systems they have in place throughout the organizations, particularly in areas that would impact product quality. The results of this exploration are one of the driving forces for the harmonization of calibration, maintenance and validation management within the pharmaceutical industry.

Blue Mountain Regulatory Asset Manager was designed with the needs of pharmaceutical companies in mind. Offering a single comprehensive solution for calibration, maintenance and validation, the software is the solution for companies looking to address the Facilities & Equipment subcategory of QSIT with a strong systems-based approach. Another significant benefit of Blue Mountain Regulatory Asset Manager to pharmaceutical companies is its collaborative features, allowing calibration, maintenance and quality personnel to work together to efficiently manage the validated state of assets and processes.

With Blue Mountain Regulatory Asset Manager, this harmonization and consolidation of systems is achieved without requiring any department to compromise on how they work with assets. Each department has the features they need to work efficiently and meet regulatory requirements, derived from our 15+ years of experience in developing asset management software for pharmaceutical companies and feedback received directly from users at all levels of these organizations.

Calibration Manager is the industry standard stand-alone Computerized Calibration Management System (CCMS), for pharmaceutical companies for whom a single consolidated system for calibration, maintenance and validation does not make sense. With over 1000 validated implementations, Calibration Manager was designed for calibration professional to meet the strict regulatory requirements in the pharmaceutical industry.

Both Blue Mountain Regulatory Asset Manager and Calibration Manager can be implemented across multiple sites for significant cost savings, including validation costs, while still allowing the unique sites and groups within sites set up the application to meet their specific requirements.