Business Areas

Introduction to Validation

Expertise in manufacturing industries such as life sciences (pharmaceuticals/bio), biopharmaceuticals, food and chemical plants, and semiconductors, It is a company that provides services, develops new IT technologies, and leads smart factory technology through convergence.
regulation Authorities Key contents
Finished Drug Manufacturing and Quality Control Standard Guidance Ministry of Food and Drug Safety, Republic of Korea, 2018 Exhibit 2. 'Computerized system'
- For all computerized systems used in pharmaceutical manufacturing and quality control standards Computerized System Target
- Applications must be validated and qualified
- Computerized work that is not computerized should not reduce product quality, process control, and quality assurance.
Data Integrity PIC/S Guide Line, 2016 Attributable
- Be able to identify individuals for work on records and alterations/deletions.

Legible
- The entire record must be legible to the naked eye. (Electron and non-electronic)

Contemporaneous
- All records must be recorded at the time of the event, decision.

Original
- Both electronic and written documents must retain the information in the dynamic state that was initially captured.

Accurate
- Quality-related results must be ensured to be accurate.
Annex 11 EU GMP, 2008 Vendor Audit
- Ensure that the software is manufactured in accordance with the quality system.

Access control
- Management using a user or password is required.

Change History of Data
- The history of the change and the reason for the change are requested (audit trail)

Security of Data
- Equipment data must be secure against intentional or accidental hazards.

Backup of Data
- Regular backups of data are required.
21 CFR Part 11 FDA, 1997년 Electronic Record
- If you create, transform, maintain, or transmit electronic records, you must maintain the confidentiality of the authenticity and
completeness of the electronic records. Must be guaranteed and signed by the signer

Response strategies

  • STEP 01Validation Plan
    • Initial Impact Assessment

      By defining the "Determination of System Impact" according to the Initial Risk Assessment item presented in the ISPE Guideline, we prepare the basis for the validation of the relevant system.

  • STEP 02 Specification
    • URS Risk Assessment

      Through the risk assessment of the generated URS, it confirms the compliance with the validation and data integrity (electronic record) at the project stage required by the current regulatory agency, supplements the required items, and defines the scope of verification in the later validation phase.

    • Functional Risk Assessment

      Derive Risk Scenarios for Each Component of the Vendor's Design Document, Rank the Risks, And Suggest Risk Reduction Measures Based on the Ranking.

  • STEP 03 Test
    • URS Risk Assessment

      Derive test scenarios based on data integrity and completeness criteria for system functionality to prove that they meet the standards required by regulatory agencies

  • STEP 04 Test
    • Validation Report

      After the completion of IQ/OQ, the Risks and rankings are validated to ensure that those risks are Eliminate and ensure that it is mitigated to an acceptable level.

Validation Life Cycle