idsTrust

ENG
Contact Us

CSV Consulting

CSV Consulting that guarantees accurate inspection of IT systems

Service

idsTrust CSV Consulting

We will strengthen the quality level of the IT system
through the implementation of CSV in an international standard method

Computer System Validation (CSV) is the process of establishing documented evidence at a high level of proving that a computerized system operates consistently according to predefined specifications.
The compliance industry has recently developed many processes that depended on manual work into automated systems (Computerized Systems) as part of ensuring process integrity.

In this process, many computer systems (H/W, S/W) are used, CSV allows you to prove that these systems are operating consistently and as planned.

Process

We provide services for the operation of computer systems with defined standards

We manage cost and period efficiently by carrying out customized
CSV considering the customer's situation.

  • Plan
    Write URS
    Conduct risk assessment
    Preparation of validation protocol
  • Write
    Write a functional requirement specification
    Create design specifications
    Design qualification and
    summary report creation
    Create a requirements tracking table
  • Development
    Creation of installation/operation/
    performance qualification scenarios
    Writing SOPs
  • Evaluation
    Installation qualification
    Performance qualification

Why idsTrust?

Why do you need CSV Consulting services?

In accordance with GMP (Good Manufacturing Practice) regulations,
It is mandatory to do CSV for the system you use.
Also, CSV is an essential factor for securing the quality and stability of the computer system that customers will use.

  • U.S. FDA CSV Mandatory
    U.S. FDA CSV Mandatory
    CSV mandatory application to systems used for pharmaceutical
    products produced and distributed under cGMP
  • Domestic MFDS CSV Strengthening Trend
    Domestic MFDS CSV Strengthening Trend
    Domestic cGMP regulations are strengthened to strengthen regulatory cooperationRelevant regulations: ‘Regulations on safety of pharmaceuticals, etc.’, ‘Regulations on pharmaceutical manufacturing and quality control’
  • Reflecting international audit trends for overseas expansion
    Reflecting international audit trends for overseas expansion
    Demonstrate data forgery and minimization of human errorDemonstrating the science of performing validation
  • Ensuring system quality and safety
    Ensuring system quality and safety
    Securing the quality and safety of the system by supporting CSV, which is difficult to respond to in the field of QA, QC, and production

Why idsTrust's CSV Consulting service?

 

  • High-level CSV manpower
    We have a group of experts with experience
    in pharmaceutical QA/QC. We also perform user-friendly
    CSV in consideration of the needs of the field.
  • CSV methodology that can be properly verified
    A proper CSV is required. We have a proven
    methodology of Risk Based Approach
    based on ISPE's GAMP5.
  • Compliance at the US FDA level
    Supports regulatory compliance at the level required
    by the US FDA and domestic MFDS.
    Performs specialized inspections based on the PIC/S guide.
  • Linkage with ERP operating system
    Organize a CSV management system linked to ERP operation.
    We provide continuous service even after
    제공합니다.

Expected effects

Expected effects of CSV consulting service

idsTrust's CSV consulting is executed according to high-quality implementation know-how that meets cGMP, EU GMP and PIC/S standards.
Through the professional CSV methodology, your computer system satisfies the validation regulations of international standards.
A work environment is created where you can focus more on your main job rather than systemic factors.

  • Reduced project execution period
    Reduced project execution period
  • Reduce project and validation costs
    Reduce project and validation costs
  • Satisfies the requirements of international standards
    Satisfies the requirements of international standards
  • Implementation of real-time validation proof system
    Implementation of real-time validation proof system
  • Focus more on the main job rather than systemic factors
    Focus more on the main job rather than systemic factors
CSV Success Stories