1. Micro Control Solutions Stability System II rev. 6.4
Move to the next slide when the request appears
“Click” for next slide

2. 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
“Click” for next slide

3. 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
define test initiation alert and
define test completion alert and
define data approval levels
“Click” for next slide

4. 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
define applications and default locations for documents that can be “attached” to individual studies for instant recall.
“Click” for next slide

5. Admin. Level Application Settings Multi-level audit logs
application event logs
application access logs
study and specification library edit logs
“Click” for next slide

6. 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
“Click” for next slide

7. “point and click entry”
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...
“Click” for next slide

8. “point and click entry”
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
“Click” for next slide

9. Initiate a Study Inventory and labels www.microcontrolsolutions.com
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
“Click” for next slide

10. Initiate a Study Document Attachment www.microcontrolsolutions.com
attach external documents to the study
study protocol
methods
OOS or OOT documentation
investigation reports
chromatography reports
PDF, Word®, or Excel® documents among others
“Click” for next slide

11. Schedule Samples www.microcontrolsolutions.com “Click” for next slide
“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
“Click” for next slide

12. 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
“Click” for next slide

13. 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
“Click” for next slide

14. Bar Code Integration www.microcontrolsolutions.com
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
“Click” for next slide

15. 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
“Click” for next slide

16. Reporting Functions www.microcontrolsolutions.com
multiple reporting options
summary reports
define the report content
“data only” for each test
“data/dates” for each test
“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
expiration single study
expiration multiple studies
data export function
“Click” for next slide

17. Micro Control Solutions
Stability System II rev. 6.4
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:
Contact us at:  
Thank you for viewing our presentation
“Click” to close