user specification requirements, factory acceptance test, & design qualification is the part of validation it is doing because the satisfaction of the customer & full filled the user requirement

1. USER SPECIFICATION REQUIREMENTS (URS)
DESIGN QUALIFICATION (DQ)
FACTORY ACCEPTANCE TEST (FAT)
PRESENTED BY
MS. RASHMI NASARE
UNDER THE SUPERVISION OF
DR. SHEELPRIYA WALDE
PROFESSOR
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2. CONTENTS
1)User requirement specification
Characteristics of urs
URS scope
URS do’s
URS don’t
2)Design Qualification
DQ Scope
3)Factory Acceptance Test
Complete protocol
Benefits of fat
4)References 2

3. USER REQUIREMENT SPECIFICATION
• Once the end user requirements specification or URS as it is
commonly called; is documented, agreed and approved they form the
basic URS Level-1 document.
• The engineers (or vendor) can then commence the preliminary
design to establish exactly what functions are required for each of the
items specified in the user requirements specification, the end user
has listed.
• Once this functionality is documented and approved it forms the URS
Level-2 document.
• This is the final level of the URS unless software is used. 3

4. 8 GOOD CHARACTERISTICS OF USER REQUIREMENTS
SPECIFICATION
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5. USER PROFILE REQUIREMENTS SPECIFICATION
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6. •User Requirements Specification (URS) Scope
includes but is not limited to;
• Level-1, full details of end user operability.
• Level-2, full details of functionality.
• Level-3, software functionality interface.
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7. • A full description of the required system performance.
• Performance criteria, critical parameters and operating range.
• Cleaning and maintenance requirements.
• Appropriate regulatory requirements.
• Documentation requirements.
• Training requirements.
• All none industry standard testing that may be required.
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8. • Interview all stakeholders. Who is going to use the equipment?
Who is going to maintain the equipment? Who is going to be
responsible for the product? Each of these people has an interest in
how the equipment is operated. Their needs should be included in the
URS.
• Work with the validation group to establish a validation plan. The
time to plan for validation is at the beginning when you're writing the
URS, rather than at the end when the equipment hits the floor.
• If you wait until the end, you're putting the cart before the horse.
• This can lead to a compromised plan or the need to retest or re-
qualify equipment.
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9. • Include a good overview. This section should describe the machine
and what it's supposed to do. It should also include background
information, such as similar machines and processes currently being
used.
• Pay attention to word choice. Words like "shall" and "will" typically
define requirements. Words like "may" and "ought" define goals that
are desired but not necessarily required. Make sure your word choice
clearly differentiates requirements from desired outcomes.
• Include supporting documentation. If a standard or other
specification is referred to, it should be included as an attachment.
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10. • Don't use time-based metrics. Today, performance metrics are almost
always written as a time-dependent measurement. For example, "100
products per minute." This approach is too vague and does not take into
account product yield and quality.
• Don't use broad, sweeping statements. For example,
"must be 21 CFR Part 11 compliant." Be specific about the elements within
the compliance. What part of 21 CFR Part 11 needs to be compliant? Which
records do you need to comply with? 1
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11. • Don't cover functional requirement specifications (FRS) in the URS.
The overall intention of the URS is to describe what the equipment is
supposed to do. How it performs is not a function of the URS.
• Don't place multiple requirements in a single section. This makes it
hard to test and validate each independent requirement. Each
requirement should be numbered and stand on its own.
• Don't duplicate requirements in multiple sections. You don't want the
same requirements repeated in five different sections of the
document. This causes unnecessary work. Rather, collect the
requirements in a general section and test them once.
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12. DESIGN QUALIFICATION
• Design Qualification is used at the stage where a design that has been
developed from the URS, is reviewed and documented by competent
persons to ensure that the designed equipment, if built, will satisfy all
the detailed specified requirements.
• The Design Qualification is the only document that is going to
confirm that the design will work.
• It must be carried out by qualified people who can challenge the
design performance.
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13. THE SCOPE OF THE DQ MUST INCLUDE BUT IS NOT LIMITED TO:
• Verification that the design will achieve the URS requirements.
• Verification that the design is cGMP, and where software is used ,
conforms to the life cycle model requested in the VP and detailed in
GAMP 4.
• Verification that the design complies with the VMP.
• Verification that the utility services required are available and
validated.
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14. • Verification that the system will be calibratable.
• Verification that the system will be maintainable.
• Verification of operation staff training requirements.
• Verification that the system will operate in a manner safe to both
product and staff.
• Verification that the system conforms to all applicable national
standards and guidelines.
• Verification that all the required support documentation is specified.
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15. • DOCUMENT ATTACHED TO URS COPY:
• Proposed and Existing Layout.
• DOCUMENT ATTACHED TO DQ COPY:
• Purchase Order copy.
• Packing List.
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16. FACTORY ACCEPTANCE TEST (FAT):
Establishing documented evidence that the vendor fabrication
process or materials and completed equipment meet vendor and
customer specification.
The objective of FAT is to verify that the main items or system
meets design specification and conforms to agreed performance
intent.
The test will be performed and reported by the supplier.
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17. All test performed during FAT must be performed in accordance with
reviewed and approved protocols and procedures.
The items of equipment and system shall comply with:
- Vendor requirements and specification
- purchase specification
- design drawings
- engineering diagrams
- safety rules 17

18. •COMPLETED FAT PROTOCOL
• Maintenance and users’ manuals
• Easy-to-use training materials (OPLs, videos, etc.)
• Standard work procedures
• Standard maintenance procedures
• Recommended spare parts lists
• Certificates of compliance
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19. • As-built technical drawings (electrical, mechanical, pneumatic, and
process schemes)
• Materials certificates and data sheets
• Main equipment data sheets
• Instruments calibration certificates
• Welding processes qualifications
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20. •BENEFITS OF FACTORY ACCEPTANCE TESTING
• Customers can “touch and feel” the equipment while it is in operational
mode before it ships.
• The manufacturer can provide some initial hands on training to the
customer, giving operating personnel more confidence when running
the machinery for the first time in real-world settings.
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21. • Key project people from both sides are together, making it an ideal
time to review the bill of materials, discuss required and
recommended spare parts (for start-up and first year of operation) and
review maintenance procedures and equipment limitations.
• The thorough FAT documentation can be used as a template for the
Installation Qualification portion of the validated process/installation.
• Based on the results of the FAT, both parties can create a punch list of
additional items that need to be addressed prior to shipment.
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22.  It shall be checked that following documentation is provided:
- User manual
- Maintenance manual
- Piping and installation design
- Electrical schematics
- Process and utility diagram
- Spare part list
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23. •DURING THE FAT THE MANUFACTURER CHECKS:
• The used equipment are mending to the specification eg, compatible
HW and SW versions
• The used equipment are installed according to manufacturer’s
specification
• The input and the outputs are connected according to the drawings
• The calibration of the equipment are correct
• The trip points operate according to the requirements in the SRS.
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24. • The reset functions operate according to the SRS
• The alarms operate according to the SRS
• The operator functions operate according to the SRS
• The bypass functions operate according to the SRS
• The manual shutdown functions operate according to the SRS
• The diagnostic alarm functions operate according to the SRS
• The associated software operate according to the requirements in the
SRS the outputs and their actions behave according to the SRS
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25. PROCESSES DONE AFTER FACTORY ACCEPTANCE TESTING
• Check of documentation
• Confirm vendor’s/dealer’s schedule for completing all
documentation.
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26. REFERENCES
• 1)
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