Student Login |


Sunday, June 20, 2021
Home » GDocP: How to Write an Effective Equipment User Requirement Specification (URS)

GDocP: How to Write an Effective Equipment User Requirement Specification (URS) (ELM-127)

Certification Training
Method of Training: Online / Self-paced eLearning.
Credits: 0.1 CPD Credits.
Duration: ~60 minutes.
Self-paced Training: 24/7 access to course.
Enrollment Period: 3 months.
CPD Accredited TrainingCatalog: Good Documentation Practices.
Demonstration: Try one of our FREE courses.
Certificate: View sample certificate.

PRICE: USD $199.00

Document a dedication to your career and job performance by earning a training certification from Biopharma Institute.

Biopharma Institute LogoTraining Program: GDocP: How to Write an Effective Equipment User Requirement Specification (URS)
Training Provided By: Biopharma Institute
Website: https://www.biopharmainstitute.com

Schedule: Self-paced. Immediate access to training materials upon ordering.

Description: Online training with immediate access upon enrollment. Biopharma Institute ReviewsUser requirements should be the starting point of any project you are working on. Time well-spent developing solid user requirements will help you enormously further down the line when you need to test your new equipment and associated software. A poorly written URS can result in miscommunication between the end-user and the equipment or system manufacturers which in turn can lead to wasted time, money and also project delays. In this course, we will learn how to write an effective Equipment URS.
Certification Requirements: Students must view the entire program and successfully pass an online, multiple-choice final assessment with passing score within a 90-day period of time (180 days for Professional Certification Programs). Certificate is accessible in PDF format immediately after satisfying requirements.


GDocP: How to Write an Effective Equipment User Requirement Specification (URS) course is included in the following Professional Certification Programs:



Good Documentation Practices (GDocP) Professional Certification: Review the individual courses included in this program (see below) for program descriptions and outlines. This online training program includes immediate access after enrollment. Username, password, and instru ... Learn more

COURSE OUTLINE:


Introduction
Overview
Learning Objectives
Who Should Take This Course?
Course Modules

URS Basics
What is a URS?
Benefits of a URS
Regulatory requirements
URS preparation process
Step 1: Identification of the URS team
Step 2: Outlining the scope
Step 3: Information gathering
Step 4: Data analysis & draft URS document
Step 5: URS reviewed by designated reviewers
Step 6: URS reviewed by designated reviewers
Equipment URS document structure
Knowledge check

How to Write User Requirements
Key considerations
Writing the specification and project cost
Legal action
A typical example
Contract fundamentals
The requirement specification template
Requirement specification template - tips
Citing regulatory standards
Citing regulatory standards - example
Citing regulatory standards - basic format
Performance Vs design objectives
Performance Vs design objectives - specification example
HPLC/GC example
Quantities
A quantities example
Verification of requirements
Verification of requirements - examples
Tolerances
Tolerances - examples
Acceptance criteria
Acceptance criteria - examples
Warranty
Warranty continued
Knowledge check

How to Create a Bullet Proof URS
The starting point
Get SMART
Clear & concise
One requirement at a time
Change control
Testable
Avoid duplication
Prioritize requirements
Design review & traceability
Not fully defined
Clear communication
Business and process knowledge
Ownership
Typical equipment URS
Requirement planning pitfalls

Suppler / Vendor Management
Audit your vendors and suppliers
Compare your vendors and suppliers
Functional or design specifications
User documentation and training
Requirement planning pitfalls

Conclusion


Final Assessment


Certification

COURSE OBJECTIVES:


Skill Level:
Intermediate

This training program has been developed to train employees with Intermediate Knowledge of Good Documentation Practices (GDocP).

Online Training: The Benefits of Remote Learning & eLearning

  • Immediate access to training: Instructions, username, password, and receipt of payment are emailed instantly upon online enrollment.
  • Optimized for learning: Courses include voice-overs, easy navigation, progress checks, and high-quality animations to increase retention of subject matter.
  • Self-paced courses: 24/7 access to individual courses for 90 days, and for professional certification programs for 180 days.
  • Flexible final assessments: Assessment testing include multiple-choice questions and can be taken repeatedly until a passing score is achieved.
  • Direct access to certificates: Certificate of completion is instantly available once course requirements have been fulfilled.
  • Verification of training: Certificates can be verified online, and digital badges are issued for all Professional Certification programs.
  • Tuition reimbursement: Some employers may reimburse for training expenses; check on your company's training reimbursement policy.
  • Financial assistance: Payment plans are available to those who qualify. These are offered when paying electronic invoices, online. You must first request an invoice to be considered. Alternatively, purchasing individual courses one at a time is also an option.
  • Purchase orders (POs) accepted: If a PO is required by your company, request an invoice to start the procurement process.
  • Corporate LMS compatibility: All courses are SCORM compliant and can be delivered from most corporate Learning Management Systems.
  • Secure and safe access: Website and LMS provide an encrypted connection with firewall protection and daily scans for optimal level of security and performance.
  • Career advancement: Professional certifications help demonstrate your interest and dedication to job performance, and may be helpful for those seeking a new career or transitioning to different positions within their organization.

Contact Us:

For more information on the Biopharma Institute's training programs, or to suggest a course, please complete the form located below. Alternatively, you may call toll free in the US: (888) 4-BIO-LRN, international callers can dial (201) 301-8370.

Information Request / Suggest a Course Form:

NAME:
COMPANY:
ADDRESS:
CITY:
STATE:
ZIP CODE:
COUNTRY:
PHONE:
EMAIL:
 
Enter the number from the image above
COMMENTS or Suggest a course:
(For pricing information, please provide us with as much detail as possible about your training project):