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Validation: The Life Cycle of a Software Validation Protocol (ELM-111)

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: Validation for BioPharma Companies.
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: Validation: The Life Cycle of a Software Validation Protocol
Training Provided By: Biopharma Institute

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

Description: Online training with immediate access upon enrollment. Biopharma Institute ReviewsIn many regulated environments both product software and software that could impact product quality are expected to be validated. The scope of this course is intended to focus on the development and execution of test protocols. While this approach and these techniques apply to regulated environments, they are intended to be practical enough for any environment.
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.

Validation: The Life Cycle of a Software Validation Protocol course is included in the following Professional Certification Programs:

Computer System Validation for Beginning Professionals: 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


Learning objectives
Who should take this course?
Module overview

Introduction to Software Validation
Best practices
Introduction to software validation
Types of software

Documentation Infrastructure
The validation master plan (VMP)
Ensure a solid foundation
Ambiguous words
Run-on requirements
Requirement traps
Product software requirements
Organize requirements
Review activity

Protocol Development
Protocol development
Define test objectives
Test development considerations
Considering precision
Trace requirements to test objectives
Organize the protocols
Formal protocols

Installation qualification
Operational qualification
Performance qualification
Static analysis
Unit-level testing
Dynamic analysis
Ad-hoc or exploratory testing
Misuse testing
Conceptualize the test
Set up the test
Equipment and software used for testing
Write the test steps
Use of screenshots
A few more details
How much is enough?

Preparing for and Executing Protocols
Protocol execution preparation
Identifying test personnel
Gathering test equipment
Executing the protocols in a controlled environment
Recording test results
Deviant behavior
Procedural errors in the expected results
Handling attachments


Final Assessment



Skill Level:

This training program has been developed to train employees with Intermediate Knowledge of Computer System Validation.

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.

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