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DOCUMENT NO.: REV.: DCO NO.: Rev. Date:

TITLE: SAMPLE - MISys Manufacturing Software Qualification

1.0 PURPOSE
The purpose of this Operational Qualification (OQ) Protocol is to define and execute a process that
will validate the capabilities of the MISys software to satisfy the requirements of Good Automated
Manufacturing Practices fifth edition (GAMP 5) published by the International Society for
Pharmaceutical Engineering (ISPE). More specifically this application will be tested in conjunction
with the relevant procedures SOP’s (Standard Operating Procedures) and WI’s (Work Instructions)
that are or will be used by the Company in its operating environment.

2.0 SCOPE

This protocol will be used to qualify elements of the MISys manufacturing software that will be used to
support the company’s manufacturing and quality processes. Within the MISys application and the
related business processes, the focus will include:

2.1 MISys Components

2.1.1 Loading and maintenance of product information
2.1.2 Loading and maintenance of supplier information
2.1.3 Processing purchase orders for production-related materials
2.1.4 Processing inventory movement and physical inventory and transactions
2.1.5 Processing manufacturing orders
2.1.6 Transferring finished products to the sales management system (Quickbooks)
2.1.7 Tracing Lot and Serial # data (including expiration dating) to support requirements of a
product recall
2.1.8 Management reporting

Other business software - Note: list here any other “relevant” software applications; e.g. Quickbooks,
which may integrate or interface with MISys and indicate whether or not they will be included in this
validation protocol.)

3.0 REFERENCES

4.1 References - (NOTE: Here it is suggested that you list the applicable SOP’s or Work
Instructions that will be referenced during the Validation process such as “Adding and
Maintaining Bills of Material”, “Processing Purchase Orders”, etc.

DOCUMENT NUMBER TITLE

GAMP 5 A Risk-Based Approach to Compliant GxP Computerized Systems –
Fifth Edition
SOP
SOP
WI
WI
WI
WI

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4.2 Definitions: (Note: Here you should list and define the various terms that will be used
repeatedly throughout the document. Some examples are provided below)

TERM DEFINITION
Computer software that automate a specific business process or
Application
processes.
Computer equipment including servers, printers, disk drives, tape
Hardware drives, I/O equipment, communication equipment, workstations, and
other devices as required to host and interface with software.
Shared boundary across which information is passed between
Interface
systems.

Standard Operating
Instructions for executing a process.
Procedure (SOP)
Work Instruction (WI)
Document that links user requirements and/or functional specifications
contained in the SRS to the tests conducted in the IQ, OQ, PQ test
Traceability Matrix (TM)
protocols, in order to verify that all requirements and specifications
have been verified.
Documented evidence that provides a high degree of assurance that a
Validation
system performs its intended functions accurately and reliably.
Risk The possibility of incurring harm.

4.0 SYSTEM DESCRIPTION

4.1 MISys Application Software - MISys Small Business Manufacturing Software (MISys modular
software application that is designed to set up and maintain master files of component items,
bills of material for its products, and supplier information. In addition it will be used to process
transactions for all purchasing and manufacturing activities, including recording and tracking all
required lot and serial # activity. Note: here describe any applicable interfaces to other
relevant software applications. .
4.1.1 Software Design - the MISys software application is modular in nature and does not
allow for any modification or customization of the underlying software code by the user
organization. It does, however, enable the user organization to select from a number of
pre-defined configuration variables, so the company can adapt the software to more
closely match its unique business requirements.
4.1.2 Software Version and Modules – Note: here describe the release of the basic (BMS)
MISys software and any additional modules that will be installed. Additional MISys
modules may include:
4.1.2.1 Advanced Purchasing
4.1.2.2 Advanced Production
4.1.2.3
4.1.3 Implementation Process – Note: provide a brief description of the implementation
process including training, changes to current procedures, etc.

4.2 Primary documents to be released or updated: Note: here you s list the primary documents
(SOP’s, etc) that will be either updated or newly released during the implementation
process.

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4.2.1 .
4.2.2 .
4.2.3

4.3 Hardware Environment - Provide a detailed description of the computer environment

(hardware and network) that the application will be processed on.
4.3.1 .
4.3.2

4.4 Software Environment – Provide a description of the network operating system and all
related software applications
4.4.1 Operating Systems – Microsoft Windows Server ….
4.4.2 Software Packages
4.4.2.1 Intuit QuickBooks ….
4.4.2.2 MISys Manufacturing Version….
4.4.2.3 Microsoft SQL ….
4.4.2.4

4.5 Security - the server is housed (Describe where it is housed and who has physical access)
System administration - is currently provided by: Provide a description of the IT organization
or outside provider. The specific components of the security environment include:
4.5.1 Operating system –
4.5.2 Database – Stored on:
4.5.3 Server console – Access limited to:
4.5.4 MISys Manufacturing – Defined security roles are established within the application.
Users are assigned to security roles based on their job responsibilities

4.6 Operational Support – Describe responsibilities for:

4.6.1 Daily operational support-
4.6.2 Installation and maintenance manuals for vendor-supplied equipment - Maintained by:
4.6.3 Equipment operating procedures – Maintained by:
4.6.4 Equipment maintenance procedures – Maintained by:
4.6.5 Application source code – Maintained by commercial software providers

4.7 Disaster Recovery Plan - the disaster recovery plan includes the computerized systems and
associated equipment. The plan defines the business procedures in order to continue business
operations (including possible interim manual operations). The resources for the disaster
recovery plan include the following:
4.7.1 Hardware inventories – Maintained by:
4.7.2 Software inventories - Maintained by:
4.7.3 System recovery includes:
4.7.3.1 Full back up including system state of all servers to local and offsite storage
medium – Describe frequency and provider including audits, etc.
4.7.3.2 Email is maintained by:
4.7.3.3 All other servers (file, application, etc.) are hosted at:
4.7.3.3.1 Server Disasters – Describe how they will be handled
4.7.3.3.2 Site Disasters or Regional Disasters – (flooding, earthquake, etc.) that
impacts more than one single hardware server will be treated on a case by case
basis as follows:
4.7.3.3.2.1 Assess damage – An inventory and assessment of functional
equipment will be performed to determine proper course of action.

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4.7.3.3.2.2 Service restoration – Depending on the severity of damage to

equipment, service may be restored using the following methods:
4.7.3.3.2.3 Use existing undamaged hardware. If restoration is possible using
the existing hardware, service will be brought back on line.
4.7.3.3.2.4 Acquiring new hardware (in case of regional disaster), the process
will require new hardware to be purchased as soon as practical after
service has been restored.

5.0 TEST ENVIRONMENT

5.1 MISys Software - the MISys test system will:
5.1.1 Define the release of MISys that will be installed:
5.1.2 be performed on the latest copy of the database that has been configured and prepared
to meet the requirements for subsequent use in the production environment,
5.1.3 have all of the configuration parameters set to be identical to those that will be used in
the subsequent production environment,
5.1.4 contain the Company’s most current item master and bill of material data,
5.1.5 contain the current set of “Approved Suppliers” and the associated items for which they
are approved,
5.1.6 have “zero” inventory balances for all items to be utilized in the protocol, and
5.1.7 contain the same user security settings as will be used in the production environment

6.0 Note: nothing defined here – should renumber

7.0 RESPONSIBILITIES

Role Responsibilities
 Project management and planning
 Control of project activities, resources and costs
 Monitor progress and initiate corrective actions where
necessary
 Ensure issues and project objectives are addressed and
resolved
Project Manager  Setting-up and monitoring the test database environment
and validation process
 Report to sponsor and/or senior management
 Work with quality to ensure compliance by submitting a
summary report describing the results of this OQ exercise,
which shall then be approved by Operations,
Manufacturing and QA/RA
 Ensure compliance with appropriate regulatory and quality
requirements as well as company policies and procedures
Quality
 Review and approve deliverables
 Approve system release for production use
 Implement and manage the system for the user
System Owner/Business
community
Owner
 Review and approve deliverables
 Executing protocol, collecting test data, and signing off
Functional Business Users
test cases they perform
 Author deliverables
Validation  Review and approve deliverables
 Assist with execution of protocols

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Role Responsibilities
 Establish and maintain computer infrastructure equipment
Information Technology
per corporate policies and procedures

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8.0 DATA MIGRATION

8.1 Pre-Qualification - The initial migration phase of critical data into the MISys database shall be
done as described below. This phase will be completed prior to execution of this validation
protocol.
8.1 Item Master data – the controlled list of components, assemblies and their associated
data values shall be transferred to pre-formatted Excel spreadsheets. After initial review
and verification, the data from these spreadsheets shall be electronically imported into
the MISys database using standard data import functionality contained in the application
software. Subsequent to the initial data loading, MISys-generated standard reports shall
be used to verify the accuracy of the data loading process and results of the Item Master
data load shall be documented in the trace matrix in Section 9.0.
Item Master Data
Source Data Target Data
Part Number Itemid
Description Descry
Revision Ref
Unit of Measure uOfM
Purchasing Unit of Measure poUOfM
Conversion Factor uConvFact
Account Set Glld
Part Type Type
Lot/Serial Track Track
Standard Cost cStd
Lot/Serial Method lotMeth

8.1 Product Structure data (bills of material) –the controlled source of product structure
data, including both prior and current revisions, shall be transferred to pre-formatted
Excel spreadsheets and imported into the MISys database in a manner similar to 8.1.
Again, MISys-generated standard reports have been used to verify the accuracy of the
data loaded into the MISys database and results of the Bill of Material data load shall be
documented in the trace matrix in Section 9.0.
Bill of Material Header
Source Data Target Data
Bill of Material Item bomItem
Bill of Material Rev bomRev
Rollup Rollup
Multiples Mult
Yield Yield
Auto Build autoBuild
Last Maintenance Date lstMainDate
ECO Number ecoNum
Overide Ovride
Assembly Lead Time assyLead
Quantity Per Lead Time ‘qPerLead
Revision Date revDate
Effective Start Date effStartDate

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Bill of Material Detail

Source Data Target Data
Bill of Material Item bomItem
Bill of Material Rev bomRev
Bill of Material Entry bomEntry
Bill of Material Number lineNbr
Part ID partId
Quantity Qty
Source Location scrLoc

8.1 Supplier Master – The Company’s principal source of supplier information is contained
in the QuickBooks accounting software application. The MISys software functionality will
have been used to import supplier data into the MISys database. Subsequent to the data
loading, MISys-generated standard reports will have been used to verify the accuracy of
the data loading process and results of the Supplier data load shall be documented in the
trace matrix in Section 9.0.

8.2 Post Qualification - following the successful conclusion of this protocol, the following additional
critical data will be migrated into the MISys database just prior to “going live”:
8.2 Inventory data – a complete physical inventory will be taken of all items used in the
Company’s production environment including their lot # and serial # identification data.
This will be done for all stocking locations. After management audit and acceptance, this
data will be loaded into the MISys database using the MISys software’s standard physical
inventory functionality.
8.2 Supplier commitments – all relevant data pertaining to outstanding purchase order
commitments for production-related materials will be manually loaded into the MISys
database. Again, standard MISys reports will be printed and user shall verify the
accuracy of this data.
8.2 Production orders – at the onset of using MISys in the production environment, the
users shall begin loading entirely new manufacturing orders into the MISys database
following the established procedures.

9.0 TRACE MATRIX - FUNCTIONAL REQUIREMENTS, TEST CASES, ACCEPTANCE CRITERIA

The trace matrix lists the business requirements, test case summaries, and acceptance criteria. The
detailed test cases are included in Appendix A.

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Requirement Test Case Acceptance Criteria Verification

A. Loading and maintenance of product information
A1. The system shall TC-A1: Import an entire list of existing TC-A1: All imported
import item master items (part numbers) from Excel. Run item data must
detail data from Excel. MISys Item Master Detail report and match Excel data
compare each item’s data to the data in with zero (0) errors.
Excel.
A2. The system shall TC-A2: Add the following new items TC-A2: All item data
allow production items manually – 1 component specification, 1 must match source
to be entered DHR with 2 existing items and new item, data with zero (0)
manually. 1 manufacturing material on it. Run errors.
MISys report and compare each item’s
data to the source data.
A3. The system shall TC-A3: Add the following new items TC-A3: All item data
allow R&D items to be manually – 1 component specification must match source
entered manually. and 1 parent assembly item. Run MISys data with zero (0)
report and compare each item’s data to errors.
the source data.
A4. The system shall TC-A4: Import a list of existing BOM’s TC-A4: All imported
import bills of material from Excel. Run MISys Bill of Material Bill of Material data
(BOM’s) data from Detail report and compare each BOM’s must match Excel
Excel. data to the data in Excel. data with zero (0)
errors.
A5. The system shall TC-A5: Add a new BOM which also TC-A5: All updated
allow BOM’s to be contains an assembled item as a Bill of Material data
entered manually. component. Run MISys Indented Bill of must match source
Material Detail report and compare the data with zero (0)
data on the report to the source data. errors.
Confirm also that the component data
for the assembled item from the source
BOM are also displayed.
A6. The system shall TC-A6: Change the following existing TC-A6: All updated
allow items (both items – 1 component specification, 1 item data must
production and R&D) to DHR, 1 manufacturing material, and 1 match source data
be changed. R&D. Run the MISys report and with zero (0) errors.
compare each item’s data to the source
data.

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B. Loading and maintenance of supplier information

B1. The system shall TC-B1: Import (5) existing suppliers from TC-B1: All imported
import suppliers from QuickBooks and confirm the accuracy of supplier data must
QuickBooks. the data between the two databases. match source data
with zero (0) errors.
B2. The system shall TC-B2: Add additional data fields TC-B2: All newly
allow supplier data, (required by MISys) to the newly enter entered
including status, to be imported supplier records and change supplier is accepted
updated and changed. status for one of the suppliers. and updated with
zero (0) errors
B3. The system shall TC-B3: Link (5) existing item #’s to each TC-B3: All newly
allow items to be linked of the newly imported suppliers linked supplier and
to suppliers. (including their product codes) and also manufacturer
link each of these items to a product code
manufacturer and their product code. values are updated
and linked with (0)
errors.
C. Processing purchase orders for production-related materials
C1. The system shall TC-C1: Enter separate purchase orders TC-C1: All entered
allow purchase orders for an existing component specification PO’s print
to be entered and item, a new component specification accurately including
printed. Note: that the item, a manufacturing material item and displaying the
item’s revision # should an R&D component item. item’s revision # on
display on the printed the documents.
PO Document.
C2. The system shall TC-C2: Make changes to purchase orders TC-C2: All entered
allow purchase orders for quantity, unit price and scheduled changes are
to be changed. delivery date. updated correctly
on the newly
printed PO’s.
C3. The system shall TC-C3: Enter purchase order receipts for TC:C3: All types of
allow purchase orders a complete quantity as well as a partial receiving activity
to be received quantity and a quantity in excess of the (complete, partial
complete, partial as order quantity. Record the Lot #’s being and overfill) are
well as overfilled. received using same “existing” format processed correctly
that is currently in use. and the existing lot
# formats are
accepted.

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C4. The system shall TC-C4: Process a vendor invoice and TC-C4: The invoice
perform a 3-way match apply it to the purchase order receipt matching is
between the purchase insuring that there is a 3-way match performed
order, receipt, and between the PO receipt transaction, the accurately resulting
invoice. vendor’s packing slip and the vendor in the correct
invoice. updating of the
Order Invoice
Value report and
the invoice is
updated correctly
in QuickBooks.
C5. The system shall TC-C5: Process transactions returning TC-C5: Both types
allow previously material to vendors. The first transaction of return
received materials to is for a return against a purchase order transactions are
be subsequently which is still open. The second is done processed
returned to the after the originating PO is closed. successfully and
supplier the appropriate
data are updated
correctly.
C6. The system shall TC-C6: Produce reports for all purchasing TC-C6: The reports
provide PO information and Inventory-related transactions for correctly display all
to R&D to aid in the R&D location only thereby aiding PO and Inventory-
disposition decisions. R&D in its disposition decisions. The related transaction
reports should be able to be filtered by with appropriate
both data and transaction type. filtering.
C7. The system shall be TC-C7: Produce detailed reports covering TC-C7: The system
able to report on all purchase order receiving activities correctly displays
purchase order receipts showing quantities, dollars, scheduled the transaction
showing quantities, delivery and actual PO receipt date. detail for all PO
dollars, scheduled receiving activities.
delivery and PO receipt
date.
C8. The system shall TC-C8: Produce detailed reports TC-C8: The system
report on purchasing displaying variances in quantity and cost reports the
quantity and cost for all closed purchase orders. purchasing quantity
variances. and cost variances.
C9. The system shall be TC-C9: Produce a report summarizing a TC-C7: The report
able to report on supplier’s on-time delivery performance. provides the ability
supplier on-time to report on a
delivery performance. supplier’s on-time
delivery
performance.

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D. Processing Inventory Movement and Physical Inventory

transactions and Standard Cost maintenance
D1. The system shall TC-D1: Move specific lot quantities of a TC-D1: The
allow for moving stock raw material item and an assembled reported lot
between locations item from their original location to a quantity balances
new location. are updated in the
new location.
D2. The system shall TC-D2: Use the Dispense and Recover TC-D2: The
allow for dispensing transactions to issue or adjust the reported balances
(issuing) inventory as balances of a specific item. of the two items
well as returning are adjusted
(recovering) inventory accordingly.
and other adjustment
transactions.
D3. The system shall TC-D3: Use the Physical Inventory TC-D3: The new or
allow for inventory process to record new or adjust existing adjusted quantities
adjustments due to quantities of an item lot or serial are reported
physical inventories or quantity. correctly on the
cycle counts. updated report.
D4. The system shall TC-D4:Transfer (dispense) a quantity of a TC-D4: The
allow for the transfer raw material item from a manufacturing inventory quantity
(dispense) of inventory inventory location (STOCK) and is removed from
from raw material to “expense” it to R&D. the manufacturing
R&D for build purposes. location and is
physically available
to R&D.
D5. The system shall TC-D5: Produce reports that display the TC-D5: The reports
allow for maintaining inventory balances available for R&D use display the R&D
separate production as well as the status of Purchase Orders inventory balances
and R&D environments for R&D purposes. available only to
for materials and R&D as well as the
assemblies. open PO’s for that
are for R&D
purposes.
D6. The system shall TC-D6: Produce a report that shows item TC-D6: The report
provide the ability to lots or serial number quantities that are displays the
notify of lots expiring scheduled to expire within a given time expiration dates for
within a given period. period. lots due for
expiration within a
given time period.

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D7. The system shall TC-D7: Change a Lot’s status from TC-D7: The lot #’s
allow a lot to be placed “Active” to “On-Hold.” The lot is now status is changed to
on hold. longer able to be transacted while in this “On-Hold”
status.
D8. The system shall TC-D8: Produce a report showing the TC-D8: The report
provide inventory inventory quantity and resulting dollar displays a complete
quantity and dollar valuation for all items in the database. listing of all
valuation reports by quantities and
item. dollar valuation in
the database.
D9. The system shall TC-D9: Change the standard cost of a TC-D9: All updated
allow for roll-up of component item. Then roll-up the costs cost data must
standard costs for of its parent assembly. Run the MISys agree with source
items & BOM’s on a report and compare the cost data for data and the
controlled basis. each item (parent and component) to assembled item
the previous data on the previous report cost must
run in Step (1) above. accurately reflect
the rolled cost of its
component items.
D10. The system shall TC-D10: Run the accounting report of TC-D10: The
report the cost impact Unposted Transaction detail and identify accounting entries
of changes to standard the accounting entries generated by the on the report must
costs. cost change and cost roll-up activities agree with the
from [D9] above. Review and confirm accounting entries
the accuracy of these entries. displayed on the
source data.
E. Processing manufacturing orders
E1. The system shall TC-E1: Open and release (2) TC-E1: The
allow manufacturing manufacturing orders. The first one component
orders to be entered should be for an assembly that is also a requirements for
and printed. The component of the assembly of the each order must
manufactured item’s second manufacturing order. The agree with the list
must Revision # be component material requirements listed of component
printed on the for each manufacturing order must be requirements on
document compared to the bill of materials (BOM) their current BOM
listing for each of the parent assembly file.
items. The revision must print for both
the parent and component items.

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E2. The system shall TC-E2: Print the “Picklist” for the order TC-E2: The Picklist
allow for issue of and confirm that “unreleased” lots (Lots displays and allows
component materials still in the Quarantine location) are not issue of only
to a Manufacturing displayed as “available” for issue on the “released” lots in
Order but prevent use document or accessible on the screen on the manufacturing
of unreleased lots. which components are transferred area to WIP.
(issued) to WIP. Issue the required Released
quantities of each component to WIP. components are
The revision must print for both the correctly issued to
parent and component items on the WIP. The revision
Picklist document. data prints
correctly.
E3. The system shall TC-E3: Complete and close the TC-E3: The order is
allow for the manufacturing order for the first completed and all
completion of assembly including assignment of serial parent and
assemblies to stock numbers and linking of component lots component
from Manufacturing to the parent serial #’s. The Serial #’s requirements are
Orders being received is consistent with the transacted
“existing” format that is currently in use. correctly. In
addition, the Serial
# format is the
same as the current
format in use.

E4. The system shall TC-E4: Complete and close the TC-E4: The order is
allow for additional manufacturing order for the second completed and the
component issues to assembly after adding an incremental additional
manufacturing orders. requirement for a component item to component
account for scrapping or other requirement is
unplanned requirement. processed
correctly.
E5. The system shall TC-E5: Print a report showing the TC-E5: The
report manufacturing quantity and cost variances for the (2) reported variances
order quantity and cost closed manufacturing orders. Review are correct and
variances. and confirm the accuracy of the consistent with the
reported variances. report printed in
TC-E3.

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F. Transferring finished products to sales management system

(Quickbooks)
F1. The system shall TC-F1: Complete the transfer TC-F1: The
allow finished goods to (dispensing) of a finished goods item transferred
be transferred to into Quickbooks so that they can quantity and
Quickbooks. subsequently be shipped against related serial #’s
customer orders in Quickbooks. are updated and
able to be
transacted in
Quickbooks.
G. Tracing lot and serial # data to support quality system
requirements
G1. The system shall TC-G1: Trace and print the reports TC-G1: The lot and
be able to perform lot showing the use of (1) Lot # and (1) serial tracking data
tracking from item Serial # into the manufacturing order on per the reports
receipt to subsequent which they are consumed. Confirm the agree with the
update in Quickbooks. data agrees with that shown on the Input Document.
Input Document.
G2. The system shall TC-G2: Trace the source of component TC-G2: The lot and
be able to perform lot Lots & Serial #’s used on a serialized serial # data
tracking from a finished assembly. In addition, perform a multi- reported are
goods item to the level trace for a parent assembly which consistent with the
lowest component part has a lower level assembly and data shown on the
level. component parts on it. Confirm the Input Document.
accuracy of the lot/serial #’s reported.
H. System Administration – Security
H1. The system shall be TC-H1: Set up a Security Group which TC-H1: A unique
able to create security will provide for controlled access to Security Group is
groups which control specific menus, screens and update vs. able to be setup.
access to menus, view only functionality.
specific functions and
ability to update vs.
view certain data.
H2. Users must be TC-H2: Set up a new User ID and assign TC-H2: New User is
assigned a specific User the User ID to a Security Group. able to be setup
ID, assigned to a and assigned to an
Security Group and existing Security
required to have a Group.
secure sign-on
password.

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H3. A user can only see TC-H3: Sign on by testing the new User TC-H3: User is only
and access the menus ID and Password. Confirm that sign-on is able to sign-on
and screens and not able to be done with an incorrect using a valid User
perform the functions password. Then confirm that the user is ID and Password. In
for which they are able to see the menus and screens set addition, the User
authorized. up for the User’s Security Group as well can only see the
as experience controls over view vs. menus and screens
update capabilities. for the Security
Group and

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11.0 ACCEPTANCE CRITERIA

Test Cases will verify that the Business Requirements are met by the MISys Manufacturing
system. Each Test case will be assigned a unique number, document the Business Requirement
being tested by referring back to the Business Process Requirement and document the Pass/Fail
result of the Test Case. All the Test Cases will be Pre and Post Approved by the Project
Management team.

Test Cases which have failed will be evaluated for the cause of failure, including inadequate
procedures, inadequate test data, misunderstood Test Case execution and/or a Risk Mitigation
proposed. Failed Test Cases can have the following activities performed:
 Revise the Business Procedure to correct the failure
 Revise the test data to correct the failure
 Re-execute the revised Test Case using a new Test Case number and referencing the
old Test Case number

The test cases are included in Appendix A.

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