We are Data Integrity Expert

Under the name of PT CSV Farma Indobuana cfi pharma consulting is a professional services consulting focusing on Computerized System Validation, qualification and quality issues for pharmaceutical or medical device in Indonesia. We put our consultant as part of your team in conducting a validation process, audit, management, system life-cycle, data integrity assessment and training, everything bespoke to your business requirements. Our team with experienced in validation of several big projects such as ERP system, MES system, LIMS, Serialization and aggregation system, BAS, IT Infrastructure , GMP equipment, machinery and instrument.

Our Team Our Services

Our Services

Validation and Qualification

  • ERP System
  • MES System
  • BAS System
  • Serialization
  • Laboratory Integrated Management System
  • IT Infrastructure
  • Customize System
  • Quality Management System
  • GMP Equipment
  • Instrument Qualification
  • CSV Remediation Life Cycle

Quality and Management

  • Vendor selection
  • Validation and Qualification Process
  • Quality Management
  • Audit and Self Inspection
  • Workshop and Training
  • Data Integrity Issue

Development

  • Build System
  • Modification System
  • Integration System

Manpower

  • Validation Engineer
  • Qualification Engineer
  • Quality Personel
  • IT Engineer
  • IT Compliance
  • Database Engineer

Activities

Saturday, April 23, 2022

How to Design URS for Computerized System - Online CSV Training EP1

 This document is one of simple document in Computer System Validation, but critical as we know the document is fundamental of th project and validation. Sometime problem faced by author, system owner and other personal confuse to :

  1. Create a component of document (template).
  2. Writing the requirement relate to Computerized System.
  3. Adopt regulation point into document.
  4. Ideal method to create URS document.
With online CSV training from us, We hope all of participant get a new knowledge and understand what is function of URS document in Computerized System Validation. Our facilitator have experience as CSV Engineer and Consultant for 9 years more in Pharmaceutical and Medical Device Industries.

Check it out our eFlyer for more details:




Friday, April 15, 2022

Computerized System Validation Training and Workshop

 

INHOUSE TRAINING AND WORKSHOP COMPUTERIZED SYSTEM VALIDATION by CFI



  • Training details :
The training consist of 1 day theory and 2 days practice. Reference of training following GAMP5 ; Computer System Validation, Data Integrity and CSV Regulation (CPOB, 21 CFR Part 11, Anex 11). Demo validation using actual system on customer site.  
  • Duration : 3 days
  • Target Training :
  1. Participant understand basic of CSV, Data Integrity and regulation.
  2. Participant able to create CSV Document.
  • Target Participant from :
    • Quality Assurance
    • Quality Control
    • Information Technology
    • Engineering
    • Production
    • Warehouse
  • Capacity : 20 Seat
  • Free : Module and material, eCertificate, Tempate CSV, CSV consultation and document validation for demo.


Contact Us:
Click for WhatsApp chat 
Fajar  081210452982
Edrick 081382589383
Email: cs@cfi.co.id
Web: www.cfi.co.id











Thursday, October 14, 2021

Webinar CSV - Computerized System Validation in Laboratory

 




Registration Link: https://bit.ly/CSVlab-EMS

More information: 0812-1602-6828 / 0813-4555-6227

Wednesday, October 6, 2021

Webinar CSV - Langkah Implementasi Computerized System Validation

Proudly present our Data Integrity practitioner in Pharmaceutical industry Arnold Edrick. He will transfer knowledge regarding Baby step to implement CSV in Pharmaceutical and Medical Device Company. This event is FREE and you will get an e-certificate. Interested? Just click intip.in/csvwebinar . Thank You!








 

Tuesday, August 31, 2021

Webinar CSV - Data & Sistem Keamanan

 



Our Team

Fajar Sidik
Co-Founder / IT CSV Consultant
Arnold Edrick
Co-Founder / CSV Consultant
Agus Trisno
Validation Engineer
U. Haryadi
System Developer
Mega Permana
Sr. validation Engineer

Contact

Talk to cfi Team

Please get in touch and our expert support team will answer all your questions.

Address:

Jl. Bhineka Permai Blok T No. 4 Cimanggis - Depok, Jawa Barat 16452 Indonesia

Work Time:

Monday - Friday from 9am to 5pm

Phone/ WhatsApp:

0812 1045 2982 | 0813 8258 9383

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