This session will demonstrate a new approach to LIMS implementations eliminates the complexities, excessive customization and lengthy associated validation requirements inherent with legacy LIMS—offering fast, “out-of-the-box” deployment capabilities, no custom coding, easy integration into existing software platforms and enterprise-wide data management capabilities. Each Accelrys LIMS application comes with Workflow Editors that eliminate traditional software custom-coding processes, enabling your own internal system administrator to deploy needed applications, workflows and procedures using a simple drag-and-drop process and dialog interface. When finished with the workflow editing, a single mouse click generates a complete validation document for the application, workflow or procedure created. Built-in compliance at the “core technology” level turns qualification/validation into a simple, fast document review with no need for external validation consultants, even in regulated environments.

1. (ATS6-APP08) ADQM Solution
Deployment
Bill Buote
CTO ADQM
ADQM Business Unit
Bill.Buote@accelrys.com

2. The information on the roadmap and future software development efforts are
intended to outline general product direction and should not be relied on in making
a purchasing decision.

3. ADQM Deployment
• Objective is to provide a fast time to benefit for you
– IT installation
– IQ/OQ/PQ
– Content development: methods / process
– Qualification and Validation
• Long term objective is “Cloud” deployment
– Both public and private cloud
• Standard best practice content is being made available
now based on 15 years of deployment experience

4. ADQM Deployment
Rapid Deployment of ADQM Applications
• Environmental Monitoring (Microbiological)
• Immediate Release Solid Dosage Forms
Standard Content
• Preconfigured Entities
• Automatic Qualification Documents

5. Open Virtualization Format Package
Traditional IT installation with Best
Practice Content
OR
Pre-Configured Virtual
Machine Appliance

6. Import the Appliance

7. ADQM Application Packs
• Environmental
Monitoring
Incorporating:
• Accelrys LIMS (EM)

8. Preconfigured Application

9. DemoConfiguring Standard Content
• Edit an entity
• Run Qualification Report

10. Sample Type

11. Qualification Report

12. What is a Sample Type?
• Sample Types describe the workflow, data
capture and chain of custody for individual
EM samples.
• The package contain N pre-configured
Sample Types:
• Contact Plates
• Settle Plates
• Non-viable Air

13. What is a Location/Location Type?
• Location Types define both the information that is recorded and specific to that
type of location and the Sample Type to be collected.
• Individual Sampling Locations are then assigned the Location Type and the
property values are entered.
Property Value
Location Type Floor Settle Plate
Location Name 001 Vessel 1
Room Micro Products
Alert Limit 1 CFU
Action Limit 5 CFU
Property Value
Location Type Viable Air
Location Name 002 Hood 1
Room Aseptic Fill
Alert Limit 0 CFU
Action Limit 1 CFU

14. DemoConfiguring Standard Content
• Update a workflow
• Run Qualification Report

15. Workflow

16. What is a Sampling Plan?
• A Sampling Plan defines both the frequency of
sampling and the locations to be sampled.
• Planned sampling dates are the represented in
an interactive calendar view that facilitates rapid
workflow processing.

17. Dissolution Example Content
Dissolution
Parameters
Process
Product
/Material
Training
Supporting Content
Method
Procedure
Method
Procedures ReportsReports
Instruments
Instruments
ProtocolsProtocols
Types and
TemplatesReferenced
Modules

18. ADQM Application Packs
• Immediate Release
• Solid Dosage
• Single API
Incorporating:
• Accelrys LIMS (SSM & IM)
• Accelrys LES

19. Customers
20
1 - Routine SM Workflow
Sample is
received in the
Lab
Sample is
booked into
SM
Product
Specification is
assigned
LES Tests are
requested and
assigned
Tests are
executed in LES
Results are
posted back to
the Sample
Sample Tests
are approved
Sample
Disposition is
made

20. 1 - Routine SM Workflow Detail
Sample is
received in the
Lab
A Sample is received against a Work Request and created
as a record in the SM Module of Accelrys LIMS. Pertinent
sample information is collected as part of the record; Lot,
Market, Product, etc.
Sample is
booked into
SM
Product
Specification is
assigned
A Product Specification is a managed entity within SM which
contains all of the Test and Component records required by
the Sample. A component is a combination of result entry
field and an optional specification limit.
LES Tests are
requested and
assigned
Procedure Sessions are created in the LES directly from SM
and can be assigned to an Analyst or Group.

21. 1 - Routine SM Workflow Detail
eMethods requested by SM are executed in the LES by the
Analyst. This is detailed in Story 2.
Test results are automatically posted back to the Test
Components belonging to the Product Specification assigned
to the Sample. Any limits are checked, in real-time, as the
results are posted.
Sample and Test approvals are made in SM. A sample
disposition is made. The Work Request may then be
completed, or remain open for further related samples to
be appended.
Tests are
executed in LES
Results are
posted back to
the Sample
Sample Tests
are approved
Sample
Disposition is
made

22. Customers
23
2 – eMethod Execution
eMethod is
opened in LES
for execution
eMethod
Parameters are
collected
Inventory Data
is collected
from IM
Test Data is
manually
recorded
Test Data is
collected from
Instruments
Test Data is
collected from
Reports
Final Results
are determined
eMethod
execution is
reviewed

23. 2 – eMethod Execution Detail
An eMethod, executed in the Accelrys LES, is a generic
and reusable analytical method skeleton which can be
used many times by externalizing product specific
parameters and gathering them at execution time. See
following slide for more detail.
Consumables and Inventory, e.g. reagents, are tracked in the
eMethod using the Accelrys LIMS IM Module.
As required by the eMethod data may be entered manually
through context specific data entry fields. E.g. calendar
controls, drop downs and format specific fields.
eMethod is
opened in LES
for executioneMethod
Parameters are
collected
Inventory Data
is collected
from IM
Test Data is
manually
recorded

24. 2 – eMethod Execution Detail
Data can be gathered electronically from most RS232 capable
instruments, e.g balances and pH meters.
The eMethod will also verify the suitability of use for the
specific instrument via the LIMS Metrology Module.
Data can be gathered electronically directly from PC
generated reports, e.g. PDF, CSV, XLS. Also, direct to database
communication is standard for Empower CDS
Results may be calculated and limits applied in real time,
flagging potential issues to both Analyst and Manager. The
eMethod is then reviewed and the record completed ready
for posting back to SM.
Test Data is
collected from
Instruments
Test Data is
collected from
Reports
Final Results
are determined
eMethod
execution is
reviewed

25. Story 2 – What is an eMethod?
Parameter Name Parameter Value
Product Pseudozone
Sample Weight 1.0000g
Sample Volume 100mL
Sample Diluent Methanol
Detection Wavelength 254nm
Path Length 1cm
Parameter Name Parameter Value
Product Cureall
Sample Weight 0.500
Sample Volume 200
Sample Diluent Water
Detection Wavelength 214
Path Length 1
Parameter Name Parameter Value
Product Cureall
Sample Weight 0.500
Sample Volume 200
Sample Diluent Water
Detection Wavelength 214
Path Length 1
Parameter Name Parameter Value
Product Cureall
Sample Weight 0.500
Sample Volume 200
Sample Diluent Water
Detection Wavelength 214
Path Length 1
Parameter Name Parameter Value
Product Cureall
Sample Weight 0.500
Sample Volume 200
Sample Diluent Water
Detection Wavelength 214
Path Length 1
Sample Weight [g] 0.9998
Methanol ID 1423209
UV Equipment ID UV01
Absorbance [AU] 0.613
Potency [%w/w] 98.7
Potency eMethod [UV]
Sample Preparation
Weigh 1.0000g of Pseudozone into a
100mL volumetric flask. Dilute to
volume with Methanol.
Measurements
Measure the absorbance of the
solution at 254nm using a 1cm path
length (cuvette).
Many
interchangeable
eMethod parameter
sets

26. 2 – What is an eMethod?
• An eMethod is an analytical technique focused generic and reusable method.
• Product specific parameters such as API name or sample preparation requirements
are merged with the eMethod at time of execution.
• eMethod parameter sets are defined and managed within Accelrys LIMS.
• An eMethod is not intended to be used in the absence of the official controlled
analytical method.
• During execution procedural clarity is provided as a combination of the embedded
generic procedure text and data collection instructions, the context provided by
data collection field names and through the display of product specific parameters
are key points of the eMethod workflow.

27. 2 – What eMethods are included?
Potency (& impurities) Thickness
Dissolution Friability
Content Uniformity Water Content
CU by Weight Variation Identification
Average Weight
Appearance Generic Solutions Prep
Hardness Generic Standards Prep

28. Customers
29
Story 3 – Creating a Product Specification
Test Templates
are created in
LIMS
Product
Specification is
created
Tests are
appended to
Spec. from
Templates
Tests are
assigned
specification
Limits
Spec is routed
through
Approvals
process
Effective date is
assigned to
Spec.
Spec becomes
‘live’ on
Effective date
Spec is
available to be
assigned to
samples

29. 3 – Creating a Product Specification
A template Test is created in LIMS. This may be defined
once and used in many Product Specifications.
A Product Specification is created in LIMS and
Tests assigned from templates. It is at this stage
that specification limits are assigned.
Once defined the Product Specification is routed through an
electronic Qualification process defined by an internal
workflow.
Test Templates
are created in
LIMS
Product
Specification is
created
Tests are
assigned
specification
Limits
Spec is routed
through
Approvals
processEffective date is
assigned to
Spec.
Spec becomes
‘live’ on
Effective date
Spec is
available to be
assigned to
samples
Once approved an effective date is assigned to the Product
Specification. Once this date has been reached the
Specification becomes ‘Active’ and assignable to future
incoming samples.

30. • Standard Best Practice Content is the key to rapid deployment
• Access to this content can be provided in a number of ways
– Traditional Server Installation
– VM Appliance
– Cloud
• http://accelrys.com/products/process-management-and-
compliance
Summary

31. 32
Thank you.
Accelrys, Inc.
9 Industrial Road
Milford, MA 01757