Blue Mountain RAM
Features Guide
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Add Similar – When adding a new record (for most record types), the user can create the new record
based on an existing record. A user can configure which fields to copy over from the original for each
record type.
Administration – A designated administrator can set-up the software to appear and behave
according to an organization’s business processes for each department and/or site. Settings include,
but are not limited to, label configuration, user access, work processes and electronic signature usage.
Application Hyperlinks – A user can select one or more records from a query result, right click and
send the hyperlink(s) for each record via email. The email recipient can simply click on the
hyperlink(s) to access each record. The number of hyperlinks that can be sent in one email is limited
only by the number of query results per page. If the system is configured for HTML emails, these
hyperlinks are automatically included within schedule notification emails. Hyperlinks can also be
included for workflow-based notifications via a macro.
Archive and Delete Records – Records throughout the application can be archived and deleted to
eliminate from active use assets and related records that are no longer available or applicable. Rights
to archive, delete, un-archive, undelete and view archived and deleted items are all controlled and can
be provided to limited groups and individuals.
As Found / As Left – An instrument record can indicate the as found and as left calibration
measurement data. This is beneficial for highlighting where remediation is required, provides concrete
documentation on current condition and provides valuable information for further analysis.
Asset Records – All data pertinent to an asset is recorded in the asset master record, including
manufacturer, department, serial number, and contact person. Information on work performed is
accessible from the master asset record. The asset record is completely configurable, including field
labels, tabs, pick lists, and associated documents and reports in order to track information important to
an organization’s facility.
Audit Trail – The audit trail provides a permanent record of all changes made to the data. Each time
a record is saved and changed, the audit trail tracks the date, time, old value(s), new value(s), and the
user who made the changes. Data from a specific point in time can then be easily retrieved and
reviewed, with highlighting of the changed or signed fields. The audit viewer allows users to compare
the differences between any two versions of a record. Audit reasons can be configured to be entered
in a freeform textbox or from a pre-defined picklist. Different approaches and different picklists can be
used for different record types.
Barcode search – Use the quick search field to pull up any record automatically from the input from a
barcode reader.
Batch advance – Users with the appropriate rights can advance multiple records to the next state or
even move them into an entirely different business process rule. Select records to advance from the
query results. The user will be advised if any of the selected records have not met prerequisites to be
advanced.
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Batch assign – Through the Batch Update functionality, multiple work items can be assigned or
reassigned to an individual at once.
Batch assign schedules – This feature streamlines the assignment of events to multiple assets.
Batch sign – In cases where the review process can be completed from the query results and where
consistent with corporate policies, users can sign off on multiple records at once.
Batch update – Replace values on multiple fields across multiple records at once. The software will
confirm that the user has the right and the current state permits the update of each field to be updated
before proceeding, clearly indicating any cases where the update cannot be completed as requested.
Business Rules – Ability to incorporate the customer’s business processes into the application to
control how activity is managed by the application including the “states” of records, i.e., draft, active,
closed and when electronic signatures are applied and by whom. They also drive when and which
notifications are sent and to whom. These rules can be specific to the type of records and type of
work. Blue Mountain RAM’s Business Rules give users detailed options for tight control over their
processes.
Calibration Failure Flags – A visual indication in a list of assets to highlight calibration failures.
Change Control – The software tracks Change Control for many different aspects of an asset’s life
cycle. This includes but is not limited to the current status of an asset, changes to the maintenance
and calibration events for an asset, and like-for-like substitutions for an asset’s replacement parts.
Configurable Labels – Users can rename most of the labels for fields and tabs within the software to
match the specific terminology used at their facility. Different departments can have different labels,
giving users the utmost flexibility to collect unique data for each group.
Craft Codes – Individuals can be associated with specific crafts or disciplines (electricians, plumbers,
carpenters, machinists, welders, masons, mechanics, etc.) and then called up for work designated as
requiring that particular craft.
Data Export – Use the integrated reporting tools to export specific data from Blue Mountain
Regulatory Asset Manager or export the data to a spreadsheet from most on-screen query results.
Datasets – Datasets allow sites to separate their asset records into functional groupings to account
for variations in procedures and access rights. Datasets can be set-up by department, facility, or
however an organization wants to best manage records. Users can be set-up with different rights per
dataset.
Due Date Calculation – The application automatically calculates due dates for activity based on a
predetermined interval. These calculations can exclude non-business hours, weekends and holidays.
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Dynamic Queries – Dynamic information taken from the active session used in a saved query. For
example, there is a macro to include the active user’s display name within a notification or as part of
query. Other macros provide such information as the current day and time, business process rule and
other user information.
Document Embedding – Users have the ability to capture a document or file directly in a database as
part of the Blue Mountain RAM application rather than link to it, making the file directly accessible from
within the application. This provides greater control over the long term security of the file. Some
examples include calibration certificates, Documenting Calibrator results, equipment photographs,
Condition Based Monitoring results (temperature maps and vibration analysis) and other work data
collected outside of the application.
Electronic Signature – The Electronic Signature functionality meets 21 CFR Part 11 requirements
while offering extreme flexibility to fit a company’s business processes. A user ID, password and
reason must be specified when signing a record. Signatures can be required at various work states
with precedence enforced. The order and number of signatures can be specified. Different signature
rules can be created for different circumstances. All signatures are recorded in the audit trail and
become a permanent part of the record.
Failure Codes – Failure Codes classify the cause and remedy of maintenance failures for later
analysis to discover trends and larger issues. Failure class, problem code, cause code and remedy
codes are all configurable to provide the best representative classification for a particular situation.
Failure Escalation – A failed calibration or a problem occurring during maintenance can trigger a
notification to the appropriate users to alert them to the instrument’s status. This can be customized to
fit an organization’s business processes.
Family Tree – The family tree window provides a quick view of all records associated with the active
asset, including scheduled and past activity. The family tree not only provides a summary of activity,
but also allows for easy navigation through the different records associated with an asset.
Field Counters – Counters automatically enter a number in a field whenever a user adds a record; for
example, system IDs BMQ-001, BMQ-002, etc. This capability makes it easy to create an
identification sequence based upon the order in which records are created.
Flags – Flags are visual representations that alert users to various conditions, including past due
events, calibration failure of an instrument, and out of tolerance conditions. Flags highlight particular
information and make it easy to take the appropriate action.
Functions – Fields can be automatically populated with a username, date, time or counter. This
feature reduces data entry. These functions are also available in the query builder, for example to
request work coming due 7 days from today or are assigned to the active user.
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Groups – Individual users can be members of one or multiple groups. A group can then be assigned
specific rights and receive notifications. Any user definable fields within the software can be
configured to select an individual within a certain group.
Hiding Fields – Fields that are not being used can be hidden for a simpler screen display and data
entry experience.
Impact Assessments – On a single screen, users can perform a complete impact assessment for a
given time period to see where the asset was used in production of specific lots / batches, test runs
and work on other assets (including Standards reverse trace), what log book entries were made and
what work was performed on that asset.
Inventory Parts Management – The inventory system maintains a list and count of spare parts.
Parts can be issued, received and easily identified as they reach designated reorder points.
Order unit and order costs can also be established distinct from units and costs applied in a work
record.
Key Performance Indicators – Key Performance Indicators (KPI) are a beneficial tool for optimizing
calibration and maintenance operations. The pre-configured KPI Reports in the software cover asset
base, productivity and quality and can be expanded and configured according to specific needs.
Labor Planning – Labor requirements, either by individual or by craft, can be forecasted within the
application. These forecasts are projected, either by week or by month, based on the number of hours
or number of jobs scheduled.
Labor Tracking – Keep track of labor information, including time utilized and associated cost.
Like-for-Like Replacements Management – Designate and sign for qualified substitute parts.
Qualified like-for-like replacements can differ by how and where the part is being used. This feature
gives users the flexibility to make decisions easily and respond quickly.
Linked Fields – Administrator can configure linked fields, transferring any information from a wide
variety of records (including events, equipment, system, loop, location, lot and process records) into
the work record.
Localization – As a global solution, the software can be localized to meet the needs of different
locations. Cultural settings can correspond to local date, time and number conventions. Information
displayed in the application can be configured to a native language and all of that information is stored
separately from the main data. The application uses the UTF-8 character set, which supports almost
every language.
Locations Hierarchy – Construct location hierarchy representations of a facility and associate assets
and work within those locations. Therefore, a user can quickly locate assets and subsequent
information through the location hierarchy. Work can also be requested, performed and documented
for a location, for example changing a light bulb in a particular room.
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Log Book –Designed to store all information about an asset’s lifecycle in a single location. Users with
the rights to do so can make a log book entry for an asset. When it comes time to review the logbook
entries, quality personnel can view all logbook activity on a single form, select individual entries to
review, review all selected entries in a single window, choose which of the reviewed items to sign for
immediately and sign for all selected items at once. A complete history of logbook entries, including a
history of revisions to log book entries is maintained and available whenever the information is
needed.
Logs – In addition to the audit trail which tracks changes to the data, the log files keep track of
changes and activity in the system. Examples of such log records include changes to system
configuration and failed login attempts.
Loop Calibrations – Perform a calibration on an entire loop or on individual components. Users can
view loop calibration work at the system level. This makes it easy to analyze the history and data for
an instrument that is part of one or multiple loops over time.
Loop Records – The loop record contains information about the loop and its elements, including all
work performed on the loop. Activity is tied-in with the loop record. Like all records, it is configurable
to collect the information required.
Lot Records – These records store information about specific manufacturing lots or batches.
Typically, these lots would reference the process used and “inherit” the assets specified for that
process. The system can inform the user if all planned assets for use are pass due for PM or
calibration or are scheduled for either during the batch production schedule.
Measurement Data Set Points Calculated from Percent of Operating Range – In a measurement
data template, the set points can be specified as percent of operating range. When the measurement
data template is used for calibration work, the operating range of the asset is then used to calculate
the actual set points.
Measurement Data Templates – Designed for recurring calibration activity, the measurement
collection details (test points, tolerances, etc.) can be pre-configured using measurement data
templates. Templates can be created for individual instruments or groups of instruments. This saves
time by eliminating the need for repetitive entry of the same set points and acceptable tolerances for
each calibration and offers control over the approval process. Measurement Data Templates can be
assigned during work planning or on demand for new calibrations.
Measurement Uncertainty – Measurement uncertainty for a standard can be tracked and referenced
when it is used in an instrument’s calibration.
Measurement Uncertainty Calculator – Users can calculate measurement uncertainty within Blue
Mountain RAM, eliminating the need to use outside programs and tools.
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Meter-Based Scheduling – In addition to time-based scheduling, the application allows schedules to
be driven by meters measuring usage. A single meter can be used to schedule activities for one or
more assets.
Mobile – The application supports mobile devices including the Apple iPad and Windows Tablets.
Data can be entered directly into Blue Mountain RAM while on the floor.
Multiple Reading Data Entry – The measurement data collection table simplifies the collection of
multiple readings per set point to improve productivity. The standard deviation and mean for each set
point are calculated automatically with the ability to designate a tolerance level any reading can be
from the mean before a warning is given.
Multiple Windows – Blue Mountain RAM lets users view multiple records at once by having several
windows open at a time. This is an excellent way to multi-task and to compare and analyze data
quickly.
Multi-site Ready – To reduce validation costs and improve consistency, Blue Mountain Regulatory
Asset Manager can be implemented across multiple sites. The web-based architecture significantly
simplifies implementation and validation across multiple sites and the ability to localize the software by
site within a single implementation accommodates differences in uses and preferences across sites.
When new sites are brought on board an existing implementation, downtime during the migration of
the new site’s data is minimized by staging out the data outside of the live database before the final
import is executed.
Notification System – A notification can be sent to a user’s Blue Mountain Regulatory Asset Manager
inbox or external email address triggered by an incident, such as the need to sign a record, a
calibration or maintenance failure and a record status change. This functionality is configurable and
facilitates collaboration between departments.
Out of Calibration and Failed Calibration Automatic Flagging – Choose to have the out of
calibration and failed calibration fields automatically set based on as found and as left measurement
data respectively based on calibration, adjustment or process tolerances. Based on the configuration,
the user may than have the option to override the status assignments before they are saved.
Parts Planning – Parts requirements can be forecasted within the application, either by week or by
month, based on the number of jobs scheduled. Forecasts can be on parts stored in different inventory
points and can differentiate requirements for parts that may have multiple uses (i.e. GxP and non-GxP
uses).
Personal Queries – User specific queries that are only visible to that user, as opposed to public
queries that are available to all users.
Personnel Fields – Any user-defined field can be designated as a personnel field. This provides the
user a list of names from which to choose from. When used in combination with a notification
condition, this field identifies the recipient of the notification message.
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Personnel Records – Information about personnel are stored in personnel records, configured to
collect all the information about direct personnel, contract personnel and contract companies. Training
can be recorded for personnel to document an employee’s qualifications.
Picklists – Most fields within the software can be designated as a picklist. Lists can be either
appendable or offer a fixed list of choices. Picklists not only save time, but also guarantee the data is
entered consistently.
Planned Work – Includes work that is on a regular schedule or work that is planned but only occurs
as needed. Planned work can be configured to meet a company’s SOPs, business rules, and GxP
requirements and stored as an event to be used as a template when the work is to be performed.
Events can include, but are not limited to maintenance, calibration and validation.
Procedures – A procedure for an event can be referenced within a record. A link to an external
document containing procedure details can be included in any record. The document can reside on
the network or within a document management system.
Process Records – Process records provide a single location for information pertaining to process
lines used at a site, for example production and QC processes. The process records retain
information about the process line and the assets that make up the line. Work, such as validation,
performed on the process is also documented and managed within the application.
Purchasing – The Purchasing system in Blue Mountain RAM provides a thorough way of managing
Purchase Requisitions, Purchase Orders, Receiving, Vendors and Inventory levels. This feature lets
users track vendor information, purchase orders against the parts, purchase history information and
more. The Purchasing system allows users to streamline the process for submission of purchase
requests to order spare parts, as well as enforce purchase order approvals via electronic signatures.
Query – Queries enable users to search the database for specific records. Most fields or combination
of fields in the software can be used to locate records and specify the order in which they are sorted.
Users can apply the quick find to search for a particular record(s). A list of most recently used queries
is presented to users on the home screen for quick access to information used on a regular basis.
Queries can be personal or public.
Quick find – This tool helps users filter query results to a finer level. The query can contain multiple
and/or criteria.
Quick search – Users simply start typing the record ID for any record type in the quick search box
available from any area of the application and a list of matches is displayed. Once the result set is
narrowed to a single item that record opens automatically.
Record Layout – The record forms are highly configurable with the ability to name tabs and field
labels, reposition field locations and select field properties.
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Reporting System – Out of the box, the software utilizes SQL Server Reporting Services. The
software comes with report templates, which can be tailored to an organization’s needs. New reports
can also be created. Reports can be easily accessed from a drop down menu on records.
Reverse Traceability – Quickly and easily view instruments impacted by a specific standard during a
period of time. Configurable Reverse Traceability reports can be run directly within any standard
record.
Security – The software offers two choices for setting up system security; integrating with ADSI
(including NT security) or using the software’s built-in security system. Like NT security, the built-in
security system allows administrators to specify minimum password lengths, password complexity,
and password expiration.
Set Point Calculation – For cases where the standard and instrument units are different, to save
time, a series of set points can automatically be calculated based on range type and number of
readings.
Smart Fields – Smart Fields are a timesaving feature that allows users to auto-populate data on a
form using data from another record. For example, you can transfer failed calibration work order
information into a newly generated out of tolerance record. Smart Fields also allow you to filter
various fields values based on group, department or hierarchical relationship of preceding fields.
Standards Classification – Enhance productivity by filtering standards on a classification that users
define to narrow the list of standards for an asset’s calibration.
Standards Management – When an asset record is designated as a standard, it becomes available
to be used in an instrument’s calibration. These standards have their own calibration schedule with
the ability to provide a warning or even lock down standards that are out of calibration, overdue for
calibration, or do not have sufficient accuracy to calibrate a specific instrument. Global standards can
be shared across multiple sites.
Standards Test Accuracy Ratio (TAR) Specifications – As a standard is referenced for an asset’s
calibration, the standard’s TAR is immediately calculated. If the TAR is outside the asset’s limits, the
information is highlighted to ensure the standard applied has sufficient accuracy to calibrate that
instrument.
Storeroom Management – Users can manage and track inventory transactions to help minimize
waste and unnecessary expenses. It is integrated with Blue Mountain RAM’s purchasing, asset
management and work order systems. Key inventory template reports are provided, as well as
streamlined forms for common inventory transactions.
System Information Display – This feature allows customers to display a customizable caption so
that users are able to easily identify environments. Additionally, the color of the display is customizable
for further identification.
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System Records – Users can define systems with subcomponents. Subcomponents can include
individual assets, loops and even other systems. Like all assets, work can be scheduled and
performed against system records.
Technology – Blue Mountain Regulatory Asset Manager is a browser-based, zero-client application
utilizing the most recent proven technologies including Microsoft.NET, XML, AJAX, and WebDAV.
Built with Service Oriented Architecture in mind, integration with other systems, such as accounting
systems or LIMS, becomes more practical.
Test Events and Test Records – Tests performed can be planned through test events and managed
through test work records. These tests would generally be performed against a lot, either one
manufactured internally or one brought in from another vendor. Assets used during a test can
naturally be referenced within this record as well.
Tolerance Limits – Establish a process, adjustment, or calibration tolerance limit for each set point
with flags and configurable notifications when a point falls outside the limit. This way a problem does
not go unnoticed and can receive the appropriate response.
Training Records – These records apply to personnel, to plan, schedule and record training activity
for maintaining an employee’s qualifications and certification.
Unplanned Work – Unplanned work includes activities that are not anticipated, such as emergency
repairs and recalibrations. Unplanned work can be initiated via the work request system and carried
out using on-demand work. Unplanned work can follow a unique approval route so appropriate
procedures are being followed.
User Defined Fields – These fields throughout the application can be configured to track information
specific to your needs. These fields can be configured by dataset and site. They can be designated
as pick-lists, dates, personnel fields, document fields, report fields, etc.
User Sessions Management – The software will automatically log a user out of the system after a
period of idleness as determined by an organization. This feature not only frees up licenses for other
users, but meets the regulations of 21 CFR Part 11.
View Linked Documents – Any record can link to documents stored in document management
systems that are WebDav compatible. This allows for easy access for viewing controlled documents.
Web farms - Create high availability and network load balancing inside of Blue Mountain RAM
Where Assets Used – On a single screen, users can bring up a complete history on an asset for a
given time period to see where the asset was used in production of specific lots / batches, test runs
and work on other assets (including Standards reverse trace).
Where Parts Used – Quickly bring up a list of work that references a specific part, useful for
determining the usage of critical spares, remediating issues and responding to recalls.
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Work Order System – This system encompasses all the information required to do the work as
defined by a company’s processes. It includes the work request, the status of the work order and any
specific work associated with it. Users can easily access the appropriate information to perform a
particular activity.
Work Plans – Detailed step-by-step tasks for performing work on work records. Includes the ability to
record acceptance criteria when needed. If desired, each individual task can be signed and the work
may “fail” based on the inability to fulfill/complete a required task.
Work Request System – Now up to seven customer defined request types can be accessed and
submitted from anyone having access to the application by using the requestor licenses, available at
no cost. The form and follow-up activity is set-up by your organization based on your business
processes.
Workspaces – This feature lets the user focus on the tasks and access information relevant to their
role. For example, user A can have their workspace set-up to see a query with calibrations due and
user B can have their workspace configured to show their to do list. Users can add one or more
reports to a workspace for quick access.
