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Computer System Validation (CSV) Services

Life Sciences Organizations engaged in drug development face an increasingly challenging environment: an expanding global footprint for clinical trials, evolving regulatory requirements, dynamic partnership models, and rapidly evolving technology. At the same time, many organizations are also innovating how trials are designed and conducted, adding to the complexity. Managing this complexity could be greatly enhanced by an effective and efficient Computer System Validation (CSV) and Quality Management System (QMS).

Computer systems validation (CSV) is a critical requirement from the regulatory perspective (U.S. FDA, EMA e.t.c). The validation process is designed to provide a high degree of assurance that both new and existing computer systems will consistently fulfill their intended purpose by producing results which meet predetermined specifications and quality attributes – accuracy, reliability, consistent intended performance, and the ability to discern invalid or altered records.

Life Sciences Organizations engaged in drug development face an increasingly challenging environment: an expanding global footprint for clinical trials, evolving regulatory requirements, dynamic partnership models, and rapidly evolving technology. At the same time, many organizations are also innovating how trials are designed and conducted, adding to the complexity. Managing this complexity could be greatly enhanced by an effective and efficient Computer System Validation (CSV) and Quality Management System (QMS).

Computer systems validation (CSV) is a critical requirement from the regulatory perspective (U.S. FDA, EMA e.t.c). The validation process is designed to provide a high degree of assurance that both new and existing computer systems will consistently fulfill their intended purpose by producing results which meet predetermined specifications and quality attributes – accuracy, reliability, consistent intended performance, and the ability to discern invalid or altered records.

Our CSV process

System inventory and assessment

Determination of which systems need to be validated

User requirement specifications

Clearly defines what the system should do, along with operational (regulatory) constraints

Validation plan

Defines objectives of the validation and approach for maintaining validation status

Validation plan

Defines objectives of the validation and approach for maintaining validation status

Risk assessments

Analysis of failure scenarios

Risk assessments

Analysis of failure scenarios

Functional requirement specifications

Clearly defines how the system will look and function for the user to be able to achieve the user requirements.

Network and Infrastructure Qualification

Documentation showing that the network and infrastructure hardware/software supporting the application system being validated has been installed correctly and is functioning as intended

Installation Qualification

Test cases for checking that system has been installed correctly in user environment

Operational Qualification

Test cases for checking that system does what it is intended to do in user environment

Performance Qualification

Test cases for checking that System does what it is intended to do with trained people following SOPs in the production environment even under worst case conditions

Performance Qualification

Test cases for checking that System does what it is intended to do with trained people following SOPs in the production environment even under worst case conditions

Installation Qualification

A review of all activities and documents against the Validation Plan

Installation Qualification

A review of all activities and documents against the Validation Plan

Operational Qualification

Documents that validation activities are complete and the system is available for intended use.

Our Validation Approach

Planning and Implementation of a Validation Project

We follow a risk-centric approach for discovering validation methods with promising cost-effectiveness and productivity while maintaining compliance with existing operations and regulatory precedents.

We focus on the following factors for assessment of client systems

Software category based on ISPE GAMP® 5

GxP specifications and aspects of criticality

Supplier evaluations or audits of complexity in the system scope

21 CFR Part 11 assessment to determine e-signature, e-records and audit trail applicability

You can leverage our services in planning and implementing a CSV project

Master plans for enterprise validation and associated procedures

Accurate reporting on milestone management, expenses, tracking, and project status

Developing and implementation of the validation project plan

Analysis and resolution of regulatory anomalies such as data integrity, GxP or 21 CFR Part 11

Leveraging vendor documentation for reducing validation burden

Assessments of levels of risk in the system

Writing or consultation for Standard Operating Procedure

Supplier or vendor assessments

Specifications for Computer System

Specifications serve as a formidable element for system design, testing, and software solutions’ intended business use. Our experts recognize the requirement for specifications with accuracy, testability, completeness, and scalability on the grounds of system complexity, criticality, and risks.

You can avail the following computer system specifications with us.

  • Specifications of user requirements
  • Functional specifications
  • Requirement traceability matrices
  • Design specifications
  • Specifications of user requirements
  • Functional specifications
  • Requirement traceability matrices
  • Design specifications

CSV Testing

Testing is undoubtedly the most crucial aspect of validation projects. Comprehensive design and implementation of the testing strategy offers many advantages. You can ensure better accuracy in verifying system installation or qualifying system functionality.

Testing also assures the system aligning with its intended use according to system specifications or user requirements. The development and execution of suitable approaches for testing protocols are also done by us.

At the same time, we also utilize supplier/vendor testing alongside implementing risk-based methods for optimization and alignment with the budget and schedule for your validation project.

Our services include:

  • Verification of installed infrastructure
  • Functional testing of the application to find software functioning according to design requirements
  • User Acceptance Testing
  • Identify Accurate and Specific Traceability Matrix to ensure all requirements are traced to the appropriate design elements, verified and tested
  • Verifying the application installation alongside component configurations
  • Use-case testing for verifying alignment between software and user requirements
  • Test execution with flexibility for onsite or remote implementation

CSV Testing

Testing is undoubtedly the most crucial aspect of validation projects. Comprehensive design and implementation of the testing strategy offers many advantages. You can ensure better accuracy in verifying system installation or qualifying system functionality.

Testing also assures the system aligning with its intended use according to system specifications or user requirements. The development and execution of suitable approaches for testing protocols are also done by us.

At the same time, we also utilize supplier/vendor testing alongside implementing risk-based methods for optimization and alignment with the budget and schedule for your validation project.

Our services include:

Verification of installed infrastructure

Verifying the application installation alongside component configurations

Functional testing of the application to find software functioning according to design requirements

Use-case testing for verifying alignment between software and user requirements

User Acceptance Testing

Test execution with flexibility for onsite or remote implementation

Identify Accurate and Specific Traceability Matrix to ensure all requirements are traced to the appropriate design elements are verified and tested showing all requirements have been met.

Validation Reports

Validation reports are comprehensive sources of information for internal or external auditors as well as stakeholders. The reports provide significant information regarding the outcomes of the validation process.

Our services include:

  • Summary reports for Installation & Operational Qualification
  • Validation Summary Reports
  • Qualification testing
  • Final report on the validation results

Change Management in Computer Systems under Validation

We can help you find a reliable structure and trustworthy guidance to maintain a system’s validated state. Maintaining your systems in the validated state is essential in cases that involve the implementation of system enhancements, updates, patches, and bug fixes.

We offer the following services to help you with the maintenance of validated computer systems,

  • Planning for change control
  • Testing services such as examples of stress testing and regression testing
  • Periodic reviews
  • Updates in documentation
  • Verification of data migration
  • Review of data integrity and resolution of any identified issues

Change Management in Computer Systems under Validation

We can help you find a reliable structure and trustworthy guidance to maintain a system’s validated state. Maintaining your systems in the validated state is essential in cases that involve the implementation of system enhancements, updates, patches, and bug fixes.

We offer the following services to help you with the maintenance of validated computer systems

Planning for change control

Updates in documentation

Testing services such as examples of stress testing and regression testing

Verification of data migration

Periodic reviews

Review of data integrity and resolution of any identified issues

Consultation for Computer System Validation Compliance

Our vast-ranging experience in serving different clients alongside training their staff for computer system validation projects serves as our top strength. We provide customized instructions to our clients for computer system validation projects.

The instructions provide an in-depth overview of industry standards and best practices for developing and implementing computer system validation projects. Our experts consult thoroughly with clients to address all the compliance pitfalls that exist or could possibly arise over the course of the project.

Our vast-ranging experience in serving different clients alongside training their staff for computer system validation projects serves as our top strength. We provide customized instructions to our clients for computer system validation projects.

The instructions provide an in-depth overview of industry standards and best practices for developing and implementing computer system validation projects. Our experts consult thoroughly with clients to address all the compliance pitfalls that exist or could possibly arise over the course of the project.

Compliance Audit for Computer Systems

Another top factor that boosts our portfolio of CSV services is compliance auditing. Our team of experts has a niche specialization in reviewing the non-validated, conventional systems of clients. As a result, you can quickly identify the systems which need your attention for a computer system validation project. Our experts’ simple yet comprehensive audit can help you find the best way to achieve compliance for your overall computer system.

Another top factor that boosts our portfolio of CSV services is compliance auditing. Our team of experts has a niche specialization in reviewing the non-validated, conventional systems of clients. As a result, you can quickly identify the systems which need your attention for a computer system validation project. Our experts’ simple yet comprehensive audit can help you find the best way to achieve compliance for your overall computer system.

Validation Lifecycle Management Systems (VLMS) Implementation

Life Sciences Organizations engaged in drug development face an increasingly challenging environment: an expanding global footprint for clinical trials, evolving regulatory requirements, dynamic partnership models, and rapidly evolving technology. At the same time, many organizations are also innovating how trials are designed and conducted, adding to the complexity. Managing this complexity could be greatly enhanced by an effective and efficient Validation Life Cycle Management Solution (VLMS) and Quality Management System (QMS). However, what constitutes an effective and efficient QMS is not well defined for clinical development. Cereblis QMS Consulting Services helps to develop a flexible, holistic, clinical QMS framework to address this gap and helps Quality Management System Design, Gap Analysis, Implementation, and Improvement.
Title 21 CFR Part 11 requires companies to implement controls, including audits, system validations, audit trails, electronic signatures, and documentation for software and systems that are involved in processing many forms of data, as part of their business practices and product development. We will help you to adopt a digital system of record-keeping while being compliant & complete the digital transformation of your QMS. Cereblis will help you identify, advise and implement innovative Validation Life Cycle management (VLMS) solution to address your 21 CFR Part 11, 21 CFR part Annex 11, GAMP 5, Change management, Release Management, Risk Assessment and digitize IQ, OQ, and PQ documentation requirements.

Our VLMS Implementation Approach

We alleviate time, staff, and other resource constraints that prevent compliance and preparedness assurance — allowing your team to focus on their core responsibilities. To simplify and streamline the successful implementation of your company’s VLMS, we leverage the quality management and inspection readiness leading practices, tools, and standards developed and refined by Cereblis Validation Practice.

Our VLMS Implementation Approach

We alleviate time, staff, and other resource constraints that prevent compliance and preparedness assurance — allowing your team to focus on their core responsibilities. To simplify and streamline the successful implementation of your company’s VLMS, we leverage the quality management and inspection readiness leading practices, tools, and standards developed and refined by Cereblis Validation Practice.

1. Strategy & Assessment

  • Current process Assessment
  • Gap Identification and Assessment
  • Defining and planning the future state processes
  • Evaluation of current technology platforms
  • VLMS Solution Evaluation

2. Solution Roadmap

  • Define Capabilities
  • Design Templates and Processes
  • Develop an implementation plan

3. Implementation

  • Configuration & Setup
  • Change Management
  • Integration with Product Development & Support Systems
  • Training

4. Validation

  • Validation plan and scripts
  • Perform validation and documentation

5. Support

  • On-going system support
  • VLMS enhancements and change management
  • Training and user adoption
  • Compliance adoption, monitoring and reporting
  • Validation Operational support & Routine Audit

Let’s Build Something Great Together

Lead Source

With deep industry expertise and a passion for delivering exceptional customer experiences, Cereblis enables companies to take advantage of innovation in tech by onboarding new ways to work and execute projects by advising, implementing, and optimizing digital solutions.

4320 Winfield Road, Suite 200

Warrenville, IL 60555 USA

Phone: +1 (312)-763-8040

Email: info@cereblis.com

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