Micro Control Solutions

Stability System II rev. 6.5

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Interactive Modular Design
• displayed alert for sample pull
• displayed alert for testing initiation
• displayed alert for testing completion
• click on an alert to see the samples
in the category

• use the “Quick Call” function for

instant study access

• scan a bar code or enter the study ID #

to initiate the function

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Admin. Level Application Settings
21CFR Part 11

• application lockout timing

• separate setting for data
• application logoff timing
• password confirmation request for edits
• define access attempts
• define login display
• define password aging cycle
• define inventory pull alert and email
• define test initiation alert and email
• define test completion alert and email
• define approval levels for specifications,
study login, and data review.

• email alerts for seamless notifications for

processes to be completed.

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Admin. Level User Access Settings
21CFR Part 11

• individually assign a user’s application access

or...
• assign them to one of 5 custom designed user
groups
• add e-signature for signing summary reports or
C of A reports

• define applications and default locations for

documents that can be “attached” to individual
studies for instant recall. PDF, Word and Excel auto
located.

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Admin. Level Application Settings
Multi-level audit logs
• application event logs

• application access logs

• study and specification library

edit logs

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Library and Dictionary Templates
• product templates
• tests
• limits
• precision
• # of entries
• laboratory preference
• alert & variance limits
• test library selection option

• define multiple testing matrixes

• define default inventory requests
by interval

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System Dictionaries
“point and click entry”
• packaging components
• fills
• containers
• closures
• liners
• seals
• resins
• manufacturers
• more...

• study conditions

• reason for study

• storage location

• mfg. and packaging sites

as typical examples...

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Initiate a Study
“point and click entry”
• select your product template

• enter study information using “point and click” dictionary

options or type in required information
• company unique information can be added using “user defined”
database fields

• track the manufacturer and lot # for the

API or any other ingredients

• enter study environment

information using dictionary
options or type in required
information
• standard or user defined interval
options, both auto-calculated

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Initiate a Study
Inventory and labels

• set inventory by selecting default

option or manually enter
• make controlled label requests per interval
• max equal to requested inventory
• all labels numbered x of y by interval
• label field content is user defined
• bar code enabled
• select the label size
• define up to 4 default label formats
• label color option available

• use the label manager to generate all

requested labels

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Initiate a Study
Document Attachment

• attach external documents to the study

• study protocol
• methods
• OOS or OOT documentation
• investigation reports
• chromatography reports
• PDF, Word®, or Excel® documents
among others

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 Schedule Samples
• schedule samples
• “quick month” option
• entered time frame

• schedule options
• print/preview
• print forms
• filter by criteria
• add to laboratory pending
list

• pending list options

• print/preview
• filter by criteria
• un-pulled samples
• testing cycle
• products
• advanced query

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Bar Code Inventory Functions
• update inventory
• scanner can be detached and taken to the
chamber
• scan sample labels or entry on “inventory
bar code” report

• open inventory options

• options for bar code or manual reduction
• update by date
• take “extra”
• restore inventory

• bar code step 1

• date of the pull
• pulled by

• bar code step 2

• reattach the scanner and all scanned samples
will be downloaded and automatically updated
• or you can scan each bar code individually
while attached to the computer

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Bar Code Testing Cycle Functions
• update testing initiation/completion
• scanner can be detached and taken to the
laboratory
• scan sample labels or reporting forms

• open testing cycle options

• select initiation or completion
• options for bar code or manual entry

• test initiation/completion
• reattach the scanner and all scanned
samples will be downloaded and
automatically updated
• you can scan each bar code individually
while attached to the computer
• or manually update

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Bar Code Integration
• bar codes contain the study ID and test interval
• based on the function requested the
requisite section of the bar code is
activated
• use the “Quick Call” function to
activate a study from the main menu

• scan the bar code on a bottle or reporting form

to enter results for a study at the designated test
interval listed in the bar code

• scan the bar code on a bottle, reporting form,

or other report to:
• generate a summary report
• recall a study to edit
• generate charts and evaluations
• initiate any function that requests the entry
of the study ID

• scan the bar code on a summary report to:

• recall the study in edit mode
• generate charts and evaluations
• generate a C of A for a test interval
• initiate any function that requests the entry
of the study ID

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Data Handling and Review
• scan the bar code on a bottle or reporting form
to enter results

• enter results for each required test

• out of spec results highlighted in red
• out of alert results highlighted in blue
• compare to previously approved results
• add interval comments

• multi-level configurable approval process

• view interval summary
• data approval locks all editing functions
• compare the current results to previously
approved results

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Reporting Functions
• multiple reporting options
• summary reports
• E-Signatures (up to 3 per
report)
•define the report content
• “data
“data only” for each test
• “data/dates”
“data/dates” for each test
• “data/dates/references”
“data/dates/references” for
each test
• define the report layout
• list tests for “individual results”
• define print order
• add/remove tests from the
report
• use the bar code to activate
any functionality for the study
• highlight out of spec data if
desired
• print:
• forms
• tables
• logs
• labels
• graphics reports
• single study
• sample to sample
• shelf-life single study
• shelf-life multiple studies
• arrhenius plot
• data export function

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 Micro Control Solutions
Stability System II rev. 6.5

• Our stability software is a Part 11 compliant package

• Capable of monitoring a full scale stability operation

• Validation services available

• On site training

• Visit us at: www.microcontrolsolutions.com

• Contact us at: newCustomerInformation@microcontrolsolutions.com

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presentation
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