CSV Support during System Implementation and Operation

CAC Croit supports computerized system validation (CSV) for both our and our competitors’ products, making full use of our extensive experience. We have provided a variety of systems for clinical trials, regulatory applications, postmarketing, and pharmacovigilance.

 

Are you facing any of these issues?

  • You need a CSV draft in accordance with your company’s CSV SOPs and policies.
  • You are struggling to manage the whole project while juggling CSV implementation and modification.
  • You need to ensure that the CSV can be implemented correctly during system operation.
  • You need to know how far the CSV should be implemented.

Croit’s solutions:

  • To reduce your workload, we support your CSV activities during system implementation and operation, including CSV document creation during system implementation, change control during operation, and project management.
  • We prepare a customized plan for you from a third-party perspective.

Service

  • We also cover other companies’ packages.
  • Our support includes change/fault management.
  • We handle accompanying tasks such as account management and data extraction of a target system.

*PQ: Performance Qualification, IQ: Installation Qualification

 

Support Description
Validation document creation
  • Creation of the following documents in accordance with your CSV SOPs and document templates:
    • Validation plan
    • User requirement specification
    • Functional risk assessment report
    • Design qualification (DQ) plan and report
    • PQ plan and scripts
    • Traceability matrix
    • Data migration and acceptance test plans, scripts, and reports
    • Operation management standards
    • Training plan
    • Retirement plan and report
    • Validation report
  • Support for review of validation documents created by a package vendor
Manual creation
  • User manual in accordance with your operational procedures
  • Administrator manual including master data management
Project management
  • Management of progress, issues, risks, and documents
  • Overall project management including your tasks, ours and the vendor’s
Operation
  • Change/fault management
  • CSV during operation of multiple systems
    • Proposal of common operational rules
    • Establishment of procedures
  • Tasks accompanying CSV
    • Account management for target systems
    • Data migration

CSV document support includes creation of documents, including templates and drafts, in accordance with your specifications. The documents submitted can be revised where necessary after your review.
*The services above are examples. We also help you to select a package system taking into consideration CSV, regardless of whether or not the system is on an on-premise/cloud basis.

Benefits

  • Consistent CSV documents as we create them in accordance with your CSV SOPs and document templates.
  • Secure time for your regular operations as we take care of the CSV and coordination between you and the vendor.
  • Reduce your workload with our CSV and project management support.
  • Standardization of operational rules reduces operational mistakes and shortens training and learning periods for new staff.
  • Our CSV consultants suggest suitable plans tailored to your system scale, risks, and needs.

Experiences

We have worked with 250 cases across 20 companies

We have experience in CSV support for numerous different types of package systems, not limited to our own.

Examples of our support

  • Electronic data capture (EDC) system
  • Document management system
  • CDISC-related system
  • eCTD-related system
  • Pharmacovigilance system
  • Electronic Data Interchange (EDI) system

* CSV support for other systems and scratch systems is also available.

 


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