Implementing new EAM software is an excellent opportunity to improve processes and reduce costs.
We all know this type of project involves far more than implementing new software. It impacts just about every aspect of your organization. In fact, we’ve built our entire suite of services to support that concept.
To that end, our Professional Services team takes a holistic approach to every project. This helps you:
- Reduce implementation cycles
- Streamline processes for higher productivity
- Generate faster returns on investment
- Lower overall cost of ownership
- Build out of deeper application functionality
We work with you each step of the way from building your project team to configuration to validation. Of course, when we configure the software, it will meet your exact needs. What’s unique about Blue Mountain is that you’ll also benefit from decades of experience in GMP calibration, maintenance and software system compliance.
When you start the enterprise asset management selection process, Life Sciences companies like yours often ask, “Is the software I am about to implement really going to provide the benefits and ROI I hope it will?”.
Too many managers buy features and pay less attention to the business solutions software can provide. It should not be the number of boxes checked on a list of features but rather the productivity gains, cost efficiencies and product quality improvements that result which influences your software choice. The following short presentation outlines the ins and outs of a Project Assessment.
The on-site Project Assessment service is designed to guide you toward the EAM software solution that provides the best business case. A summary report provided by Blue Mountain Software Implementation Analysts describing areas of greatest efficiency gains contributing to improved productivity, product quality, and ROI will be the deliverable. The result is a software solution you know, even before the project begins, will provide productivity gains and efficiencies for your department and make a significant contribution to the bottom line of your company.
Project Assessment will evaluate:
- Program Objectives and Expectations
- Current System Documentation
- Existing and Desired Business Practices
- Assessment of Compliance Risks
- Organizational Business Structure
- Legacy Data and Data Migration Planning
- High Level Validation Plan
Project Assessment will provide a Summary Report that outlines:
- Productivity Gains
- Streamlined Processes
- Resource Requirements
- Software Configuration
- Accurate Cost Aligned to Plan
The result is a solution you know will meet your goals before you start that is delivered on time and on budget.
We know that implementing an enterprise asset management solution on your own can be a daunting and overwhelming task.
First, there is the unfamiliarity with the software. Second, an implementation takes time and many Life Sciences companies don’t have that time. Ultimately, this may delay the proper calibration and maintenance management of your assets, which could decrease productivity and possibly even jeopardize compliance.
We can help you with the implementation of Blue Mountain Regulatory Asset Manager. We know the software and we can help you optimize it specific to your organization. Our Software Implementation Analysts can supplement your existing internal resources by performing or assisting with any step in the implementation process. Additionally, if you are on a short timeline, the depth of our resources significantly compresses the time required to complete implementation by performing certain steps in the process in parallel.
Implementation may include:
- Site assessment: a structured review of current procedures and expectations, establishes the framework for the rest of the project
- Project management: Coordination of activity and timeline, including people and resources provided by us and interaction and resources required from your sites to minimize bottlenecks and maximize efficiency. We establish the framework for the project, including pilot site (if multi-site), validation plan, data migration plan, event timeline, goals and evaluation plans.
- System SOP generation: We work with you, using existing calibration procedures as a starting point, to develop procedures on how and when interaction with Blue Mountain Regulatory Asset Manager takes place, to create the greatest fit between new procedures with your existing best practices.
Installation: The installation of the software on local and server computers, including in the test and production environments.
- Configuration: Before implementation, we help you configure your system to more closely match your current and ideal procedures. The decisions made here will directly affect how much you get out of the software, which is then easily customized.
- System blue printing: If you are implementing a calibration management system across multiple sites or diverse groups, we help synchronize and standardize procedures across those sites as necessary. The amount of standardization required will depend on the type of data sharing you want between sites. The user group blueprint is the output of these standardization discussions.
- Training: Bringing users and managers up to speed quickly on the software can be done on site or through our regional training. In some cases it may make more sense to have one or two people trained who can then train the rest of your people and in other cases, it makes more sense to have an on-site training for all the users at once.
- Report writing: While each software package does allow a great deal of flexibility in your own ability to develop new and custom reports, there are generally some reports that either are needed immediately upon implementation or are sophisticated enough to justify expert development. The number of reports developed at time of implementation naturally varies depending on your immediate needs.
- Post assessment: We stay with you through the first day of actual use of the software and then have additional checkpoints weeks and months after the implementation. That way you continue to have extra resources available to respond to the unexpected and make sure that the final results meet or exceed expectations.
The result is an implementation solution that combines just the services you need so you can manage the calibration and maintenance of your assets as soon as possible.
We understand the time and resources a validation of an enterprise asset management system takes on your organization.
It is a major consideration when beginning the process of reviewing and purchasing a calibration and maintenance solution. You want the entire process to be completed quickly and properly so you can begin reaping the benefits of the new system.
Blue Mountain’s validation service can help your company get through the Blue Mountain Regulatory Asset Manager validation process quickly and meet compliance requirements. Our Software Implementation Analysts work under the supervision of your validation and/or IT departments to ensure best practices are being followed, as well as fulfilling internal requirements. With validation assistance, you can eliminate the time required to develop internal test scripts, free personnel to validate other essential systems and implement Blue Mountain RAM quickly.
Our Validation Assistance can include:
- Installation qualification (IQ) and operational qualification (OQ): Make sure that the installation is completed according to written and pre-approved specifications and document the system’s actual operational functioning versus specification.
- Performance qualification (PQ) script generation and execution: We work with you to develop the scripts or testing procedures to document that the system performs as required in actual working environments and conditions.
- User Requirement Specification (URS) Generation: If you haven’t developed one already, we can help you write this document that describes the required functionality from the system. It should establish what the product needs to do.
- Gap analysis between URS and Functional Requirement (FR): Examination of the gap between what you need (URS) and what the current software can provide (the Functional Requirement). We help you determine how to use the software to satisfy your needs in the most efficient manner.
- Server Qualification: The server components are qualified versus validation protocols to document that the server too is in full compliance.
The result is a well-defined, documented and organized validation that meets compliance requirements.
We know that one of the biggest concerns when purchasing a new asset management system is “What will happen with my current data?”.
It is not only about being able to access and view it, but also, and more importantly, about being able to fully integrate current and legacy data into the live system. In addition, the entire process has to follow a quality program for FDA compliance.
With our data migration service, your concerns can be put to ease. We can import your information into Blue Mountain Regulatory Asset Manager from a variety of sources, including legacy CCMS and CMMS systems, address books and Excel spreadsheets. We document and test the data integrity every step of the way to ensure a quality migration for FDA compliance. Our service reduces errors by eliminating data re-entry, improves productivity by maintaining access to legacy data and ultimately maximizes your return on investment.
Data Migration process includes:
- An initial meeting with your team and ours to discuss needs and goals
- A review of the data by our specialists
- A report by Blue Mountain with options of the best approaches
- Your team sends data sources and we prepare the final data migration plan
Data Migration service provides:
- Migrated data
- Data import report
- Access to our data services specialist and Software Field Engineers
The result is access to your existing and legacy data that you can continue to use moving forward with Blue Mountain RAM.
In GMP environments, your data is not only important to you, but to others in your organization. Asset management information is valuable to equipment and process owners, laboratory instrumentation, quality assurance and senior management.
Blue Mountain RAM has an Application Programming Interface (API), as well as utilities for providing database table views to share the most common data. With implementation activities focused on regulated life science organizations, the solutions are 21 CFR Part 11 compliant.
Now your senior management can see cost data rolled up, your instrument and equipment owners can check on status and your data can be incorporated into Electronic Batch Records (EBR). Our integration staff has experience integrating our products with the most common systems found in your facilities including:
- SAP Plant Maintenance (PM)
- Laboratory Information Systems (LIMS)
- Electronic Laboratory Notebooks (ELN)
- Manufacturing Execution Systems (MES)
- Enterprise Resource Planning (ERP)
Integration can provide significant ROI and we can work with you and your staff to define, develop and implement a solution with a quick return. From simple one way data transfer to sophisticated two-way real time exchange, Blue Mountain integration can enable you to:
- Eliminate unsynchronized redundant information
- Reduce data entry work and errors
- Strengthen compliance programs
- Foster better decision making
- See synchronized data in multiple systems
MES & LIMS Integration with Blue Mountain RAM
We understand the importance of product training in the implementation process. After all the time spent customizing and validating the software for your facility, you want your users to have the greatest productivity gains from it.
Our on-site training for Blue Mountain Regulatory Asset Manager provides users a hands-on experience with the software. In addition, you will meet the FDA regulations that require employees to be trained on systems that track critical equipment data.
On-site Training will provide:
- Our Software Implementation Analysts at your facility
- Training designed specifically for your configuration of the software
- An understanding of how to use and administer the application
- A training manual and training certificate
With today’s reduced staffing to support internal applications, you demand the highest level of technical product support from Blue Mountain Quality Resources.
You also want to ensure the investment you make today will continue to pay back for years to come. Blue Mountain offers software maintenance and support programs to fit these needs. Blue Mountain routinely gets high marks for our highly trained and experienced support technicians. Whether contacted by phone, email or the web, our techs are ready to assist.
Our software maintenance releases are planned and conducted to our Software Quality Assurance program, assuring that they are fully documented, tested and ready for use. We understand operating in a GMP environment and the importance of controlled software maintenance. Each year our Software Quality Assurance program is audited onsite by many of our customers and we look to continuous improvement to further refine it. Please consult with one of our Regional Sales Managers to learn more about our maintenance and support program.
Whether you are looking to set up new calibration, maintenance or validation programs or want to reengineer how your departments operate, Blue Mountain Quality Resources has the experience to help.
With years of experience in the Life Sciences industry, Blue Mountain can offer a broad range of consulting services in the area of GMP asset management. Through our unique position in the industry, we have accumulated many years of best practices in GMP calibration and maintenance management that can be put to work in your organization.
Current consulting engagements include driving productivity gains with paperless solutions, site standardization and driving down validation costs with GAMP 5.
Blue Mountain can work with you to develop engagement that increase productivity, have fast ROI and can be simple or complex. Our consulting services include:
- Calibration and Maintenance Management Program Design
- Calibration Master Plan Development
- Standard Operating Procedure Writing
- Instrument Data Engineering and Measurement Data Templates
- Computer System Validation Programs and GAMP 5 Approaches
Call us today to explore our capabilities and how they can best meet your scope and requirements.