Unlocking Success with User Requirement Specification: Coating Machine URS

Unlocking Success with User Requirement Specification: Coating Machine URS

In any project or system development, understanding and capturing user requirements accurately is crucial for success. User Requirement Specification (URS) is a structured document that serves as a foundation for defining and documenting user needs, expectations, and functional requirements. It forms a critical part of the project initiation and planning phase, providing a clear roadmap for the development team and stakeholders. In this blog post, we will delve into the concept of User Requirement Specification, its importance, components, and best practices for creating an effective URS document with example of Coating Machine URS( User requirement specification).

I. Understanding User Requirement Specification

A. Definition and Purpose:

  1. Definition: Explain User Requirement Specification as a document that outlines the specific needs and expectations of users or stakeholders for a particular project or system.
  2. Purpose of URS: Discuss how URS acts as a communication bridge between users, stakeholders, and the development team, ensuring a shared understanding of project objectives, scope, and requirements.

B. Key Components of URS:

  1. Project Overview: Provide an overview of the project, including its background, purpose, and key stakeholders.
  2. Scope and Objectives: Define the boundaries and goals of the project, outlining what the system or solution aims to achieve.
  3. User Needs and Expectations: Detail the specific requirements and expectations of users, focusing on their functional, operational, and performance needs.
  4. System Functionalities: Describe the desired features and functionalities of the system, including both core functions and any specific requirements.
  5. User Interface and Experience: Discuss the desired user interface design, interaction flow, and user experience expectations.
  6. Performance and Quality Criteria: Specify the performance metrics and quality standards that the system or solution should meet.

C. Importance of User Requirement Specification:

  1. Alignment with User Needs: Highlight how URS ensures that the final product or system aligns with user expectations, leading to higher user satisfaction.
  2. Scope Control and Change Management: Discuss how URS helps control project scope and manage changes by providing a baseline for evaluating proposed modifications.
  3. Risk Identification and Mitigation: Explain how URS aids in identifying potential risks and challenges early in the project, allowing for effective risk mitigation strategies.

II. Best Practices for Creating User Requirement Specification (Approximately 2,000 words)

A. Stakeholder Collaboration:

  1. Stakeholder Identification: Discuss the importance of identifying all relevant stakeholders, including users, sponsors, subject matter experts, and project managers.
  2. Stakeholder Engagement: Emphasize the need for active involvement and collaboration with stakeholders throughout the URS development process.

B. Requirements Elicitation Techniques:

  1. Interviews and Surveys: Explain how conducting interviews and surveys with users and stakeholders can help gather requirements effectively.
  2. Workshops and Focus Groups: Discuss the benefits of facilitating workshops and focus groups to encourage open discussions, brainstorming, and consensus building.
  3. Prototyping and User Feedback: Highlight the value of creating prototypes or mock-ups to gather user feedback and validate requirements.

C. Clear and Concise Documentation:

  1. Structured Format: Discuss the importance of using a structured format to organize and present the URS document, ensuring clarity and ease of understanding.
  2. Use of Visual Aids: Explain how incorporating visual aids, such as diagrams, flowcharts, and wireframes, can enhance the comprehension of requirements.
  3. Well-defined Terminology: Emphasize the need for using clear and consistent terminology throughout the URS document to avoid ambiguity.

D. Traceability and Requirement Management:

  1. Requirement Traceability Matrix (RTM): Discuss the use of an RTM to establish traceability between user requirements and system functionalities, ensuring that each requirement is addressed.
  2. Version Control and Change Management: Explain the importance of maintaining version control and implementing a change management process to manage modifications to the URS.

III. Practical Applications of User Requirement Specification (Approximately 1,500 words)

A. Software Development:

  1. Custom Software Development: Discuss how URS is used in custom software development projects to define user needs, system functionalities, and performance requirements.
  2. Off-the-Shelf Software Evaluation: Explain how URS helps in evaluating off-the-shelf software solutions by comparing their features and functionalities against user requirements.

B. Engineering and Manufacturing:

  1. Product Design and Development: Discuss the role of URS in defining user requirements for new product development, including design specifications, performance criteria, and safety standards.
  2. Process Automation: Explain how URS guides the implementation of automation systems, capturing user needs and process requirements for improved efficiency and productivity.

C. Construction and Infrastructure Projects:

  1. Building Design and Architecture: Discuss how URS is used in architectural projects to capture user requirements for functional spaces, aesthetics, sustainability, and safety.
  2. Infrastructure Development: Explain the application of URS in infrastructure projects, such as road construction, bridges, or transportation systems, to define user requirements and project objectives.

IV. Ensuring Success and Implementation (Approximately 500 words)

A. Collaboration and Communication:

  1. Project Team Collaboration: Emphasize the importance of effective communication and collaboration among project team members, stakeholders, and users throughout the URS development and implementation phases.
  2. Continuous Feedback Loop: Discuss the value of establishing a continuous feedback loop with users to validate requirements, address concerns, and ensure ongoing alignment with user needs.

B. Validation and Verification:

  1. User Acceptance Testing (UAT): Explain how UAT validates whether the developed system meets the defined requirements and user expectations.
  2. Independent Reviews: Discuss the benefits of involving independent reviewers or subject matter experts to evaluate the URS document and provide constructive feedback.

C. Change Management and Adaptability:

  1. Change Control Process: Explain the importance of implementing a change control process to manage changes to the URS, ensuring proper evaluation, documentation, and impact analysis.
  2. Flexibility and Adaptability: Highlight the need for URS to be flexible and adaptable to accommodate evolving user needs and changing project dynamics.

Conclusion (Approximately 500 words)

User Requirement Specification (URS) is a crucial document that serves as a blueprint for project success by capturing user needs, defining system functionalities, and providing a foundation for effective development and implementation. Through stakeholder collaboration, effective requirements elicitation techniques, and clear documentation, organizations can create an impactful URS that aligns with user expectations and guides the project towards success. By ensuring traceability, managing changes, and fostering a culture of collaboration and adaptability, organizations can implement URS effectively and achieve their goals of delivering systems and solutions

One Example of User requirement specification (URS) of Tablets Automatic Coating Machine

User requirement specification (URS) of Tablets Coating Machine is a list of all the requirements from the user, After the preparation of the list, the documents are sent to the manufacturer to get the required materials as per the given criteria.

The user department will raise the indent for his requirement regarding the Coating machine. Will give all the requirements in the format of URS, which include the functional and technical specifications for the Coating machine. All the specification in the written format is defined below.

  • General
  • Salient Features
  • Operational Requirements
  • Utilities
  • Maintenance
  • Inspection and Testing
  • Commissioning and Documentation
  • Training
  • Packaging
  • Deviations
  • Delivery

1. General Information of Coating Machine:

It contains Following Information

Equipment ID – To be embossed /imprinted conspicuously on the equipment

Description – The equipment shall be used for coating of different shape and size of tablet with different coating solutions.

Use of Equipment – The equipment will be used primarily for coating of the tablets of different sizes and shape.

Field Identification –

To be installed in Tablets block.

Allocated floor space for the equipment to be specified by supplier with a clear ceiling height of 3.2 m Approx.

  • Room Temperature NMT 300C and RH less than 60%
  • Non-flame-proof area

2. Salient Features of Coating Machine

General requirement

  • Unit to be compact with ease of operation.
  • A closed system with minimum dust generation
  • Ease of maintenance
  • Easily cleanable with minimum recesses and crevices.
  • All welded joints to be grinded where the product may be in contact to smooth finish and lead-free.
  • All gaskets provided to avoid leakages should be amenable for easy removal and re-fixing,
  • All electrical/pneumatic parts should be pre-wired.
  • Convenient lubrication design
  • Complete safety interlock design
  • All bolts and nuts on the exterior part of the equipment are preferable with a cap head or cap nut.
  • Parts which are required for cleaning should be provided with a quick fixing arrangement

Material of Construction –

All the contact parts should be of SS 316L and non-contact parts preferably of SS 304. SS 304 lining over entire booth base frame including electrical panel.

Finish – Contact Surface Finish Matt./Mirror

Electrical Construction – Non-flameproof.

Operational requirement –

Neocota is a complete system having all the basic sub-systems necessary for Automatic Film and Sugar Coating for Tablets. The basic sub-systems will be required as under

  • Coating PAN and PAN Cabinet.
  • Spray Unit
  • Hot air unit with three-stage filter and dehumidifier unit
  • Exhaust Unit
  • Liquid Feed vessel Unit
  • Control Unit
  • Loading
  • Tablet Unloading Device
  • Clean in-place facility
  • Safety features for Aqueous film coating

There shall be three coating Pans that are interchangeable.

Coating Pan shall be perforated.

  • PAN speed shall be 2 – 12 rpm (supplier to specify).
  • PAN shall be coupled with an AC drive (Variable drive).
  • PAN shall be air-tight and bottomless construction from the outside.
  • PAN edges shall be rounded.

Coating pan requirement:

  • One pan (supplier to specify), specifically for this machine only
  • Pan Dia (supplier to specify)
  • Pan mouth Dia (supplier to specify)


  • Through PLC
  • PLC based with minimum following features :
  • Recipe management (Number of recipes required more than 500)
  • Initial ON/OFF starter with the emergency stop of inching facility
  • Temperature / RH of air.
  • Airflow in CFM
  • Time-based functions.
  • Product screen delta pressure.
  • Filter chamber delta pressure.
  • Solution spray rate.
  • Pan RPM.

Power failure/recovery

In the event of a power failure, the system shall protect the product against damage. The system will stop in a safe mode automatically upon loss of electricity, air, or other major utility and will require operator intervention to re-start

Emergency stop –

The emergency stop mechanism(s) shall be located in easily accessible areas around the equipment as a requirement of safety precautions.

4.Utilities :

To provide utilities at ONE POINT is the user’s responsibility. Supplier to give details and drawings for exact size, location, type, capacity, etc. of the utilities required.

5. Maintenance :

The supplier should provide the following maintenance instructions,

  1. Operation and Maintenance manuals along with as-built drawings
  2. Lubrication instructions
  3. Daily checks on the machine
  4. Cleaning procedures

6. Inspection and Testing:

Equipment shall be inspected and tested by the user at the supplier’s factory with respect to DQ prepared by the Supplier and approved by Company.

In order to verify system performance, the User shall witness the execution of the Factory Acceptance Test procedures. The Supplier shall notify the User two weeks in advance of the start of this test.

The Factory Acceptance Test Specification shall be submitted to the User for review and approval prior to execution. A minimum of two weeks shall be allowed for the User to review and comment and/or approve the Factory Acceptance Test Specification.

7. Commissioning and Documentation :

  • IQ/OQ/PQ to be completed by the supplier along with Company representatives.
  • The Supplier to demonstrate the performance of the machine at the User site as per agreed terms.

The Supplier to submit the following certificates:

  • Calibration certificates of all the instruments used have traceability to NPL / NIST
  • Performance certificates of Tests conducted at manufacturer end for Motors / Gear Box / Fan and other critical bought-out items with Serial nos.


The Supplier shall provide a Project Manager for the project to provide a single communication point with the User.

Also, the following documents shall be supplied in soft (MS Word & AutoCAD) as well as hard copy

  • Functional specifications/requirements
  • Design Specifications
  • Controls tests
  • Operational tests
  • Factory Acceptance test
  • Operator Maintenance and service manuals
  • Process, and instrumentation diagram (P & ID)
  • Instrument listing
  • Control schematics
  • Control panel assembly drawings
  • Equipment Assembly Drawings
  • Spare part list
  • Hydro test reports
  • Filter’s specifications and certificates (Wherever applicable).

8. Training:

Start-up support

Supplier to train the respective technical associates of the Company on operation, maintenance, and cleaning of the equipment wherever applicable.

Post-start-up support

Telephone / Fax / E mail ID / Address

Replacement parts availability list (normal lead times shall be listed)

System improvements (supplier shall notify the user of any improvements)

9. Packaging:

Supplier to specify packaging of machine for safe transportation and delivery at the site.

10. Deviations:

Any deviation from URS shall be highlighted

11. Delivery:

As per the purchase order be delivered

About Abha Maurya

Ms. Abha Maurya is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India having more than 18 years of rich experience in pharmaceutical field. During his career, he work in quality assurance department with multinational company’s i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd, Panacea Biotec Ltd, Nectar life Science Ltd. During his experience, he face may regulatory Audit i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda,Kenya, Tanzania, Zimbabwe. He is currently leading a regulatory pharmaceutical company as a head Quality. You can join him by Email, Facebook, Google+, Twitter and YouTube

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