Building the Business Case
Blue Mountain Regulatory Asset Manager can have a profound and positive impact on your company's bottom line. Our solutions are proven to add to profitability by reducing costs, increasing throughput and decreasing risk of regulatory citation and penalties.
Building a business case for a new system is critical to the success of your project. Blue Mountain has worked with hundreds of customers to plan, implement and demonstrate the benefits of automating and streamlining your calibration and maintenance processes. Below are just some of the many ways Blue Mountain RAM has generated a fast Return On Investment (ROI).
Increase Productivity Through Streamlined Work Processes
- Paperless process control and documentation with Part 11 electronic signatures
- Reduce time and effort required to plan work
- Notifications and work flow processes streamline planning and approval process
- Sign off on measurement data templates (including process tolerances) before they can be put into use
- Increase efficiency in scheduling work
- Forecast labor requirements by individual or craft to help balance workloads and make staffing decisions easier
- Increase productivity in performing work
- All information required to do work in one place available in the field, including parts, tasks and links to documents such as appropriate SOPs
- Prompting for calibration set points means greater control and less time tracking down requirements
- Automatic flags in calibration data indicate out of tolerance conditions, which allow for immediate investigation and then automatic notifications when additional action is required
- Eliminate the need to revisit records by requiring documentation before progressing to review state
- Expedite and simplify the review process
- Notifications sent immediately when work is ready to review, with a link to the information to review
- All information to review available in one place
- Map your business processes to ensure that required signatures are applied before progressing to the next state, which eliminates back and forth and need for additional checks
- Automatically advance to the next state when all signatures have been applied so no one needs to manage the flow of records
- Use a risk based approach and understanding of asset lifecycles to reduce work frequency
Increase GMP Compliance
- Designed to facilitate compliance to CFRs for asset management
- Systems approach gives control over process to ensure what needs to get done, that it is documented done and that it provides easy answers to audit questions
- Electronic records don't get lost or misplaced like paper records could
- Single store of information means no questions about which record is the official and accurate record
- Functionality designed to facilitate compliance to 21 CFR Part 11 integral to application and therefore reliable and less burdensome
- System designed for validation and regularly validated, including validateable notification system
- Immediate notifications of non-conformances, deviations, observations and OOTs to appropriate parties, solid answer to regulatory requirements
Reduce Equipment Downtime and Increase Capacity
- More preventive maintenance during scheduled downtime, less reactive maintenance during scheduled uptime
- Reduce frequency of failures through better understanding of causes of failure
- Schedule maintenance, calibration and validation in sequence to reduce the number of interruptions to production
- Forecast labor and parts requirements to make better decisions and avoid delays due to backlog work and waiting for parts
Reduce Capital Expenditures for New Assets
- Preventive maintenance reduces failure rate and extends life of assets versus Run-To-Failure approach
- Information on bad actors and total cost of ownership improves decision making on new asset purchases
- Evaluate cost to repair versus replace with real data
- Reduce inventory costs
- Better forecasting of parts requirements reduces amount of parts and capital tied up in inventory
Reduce Scrap and Rework
- Fewer interruptions to batch caused by asset failure means less scrapped product
- Quality systems approach means better control of process and fewer out of tolerance events
Reduce Asset Service Costs
- Warranty tracking to take advantage of covered service instead of paying out of pocket
- Manage Service Contracts
Reduce IT Costs
- Harmonize calibration, maintenance and validation systems so there is just one system to purchase and maintain instead of multiple systems
- Browser-based application simplifies implementation, validation and updates
- Bring additional functions into the software for additional payback, including engineering change control, exception management, IT asset management and logbooks
Reduce Administrative Costs
- Engineers, technicians, mechanics and metrologists enter results directly, eliminating need for paper records and data entry clerks
- Eliminate duplicate data entry and management of asset records in multiple databases
- Eliminate need for fire-proof filing cabinets, paper and filing folders and associated administrative costs