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.
Catalog: 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.Training Program: GDocP: How to Write an Effective Equipment User Requirement Specification (URS)
Training Provided By: Biopharma Institute
Schedule: Self-paced. Immediate access to training materials upon ordering.
Description: Online training with immediate access upon enrollment. User 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:
Who Should Take This Course?
What is a URS?
Benefits of a URS
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
How to Write User Requirements
Writing the specification and project cost
A typical example
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
A quantities example
Verification of requirements
Verification of requirements - examples
Tolerances - examples
Acceptance criteria - examples
How to Create a Bullet Proof URS
The starting point
Clear & concise
One requirement at a time
Design review & traceability
Not fully defined
Business and process knowledge
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
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.