A computerized system is composed of hardware, software, network components, controllable functions and related files [1]. Computerized Systems Validation (CSV) is a safeguard measure implemented to ensure the continuous and stable operation of the computerized system’s established functions. It is an important part of quality assurance in the pharmaceutical and related industries.
In a computerized system, whether it is simple Excel spreadsheet data, or IT infrastructure, or even software that controls quality-related processes, these forms or systems or software need to be verified and comply with the requirements of GMP regulations and appendices . for example:
-Compliant with US FDA 21 CFR Part 11;
-China GMP2010 appendix: computerized system, verification and confirmation;
-EU Volume 4 Annex11: Computerized System
1. Overview of computerized system verification activities
According to the requirements/instructions of computerized verification in GAMP5:
Adopt the principles, methods and life cycle activities within the framework of verification plans and reports. Appropriate operation control measures are taken during the entire system life cycle, the purpose is to make the computerized system meet the applicable GxP regulatory requirements and meet the intended use [1].
The so-called life cycle refers to the need to define and implement activities in a systematic way, including the concept of computerized system, project phase, operation, and system decommissioning. The entire verification process of a complete computerized system is also carried out in accordance with the entire life cycle of the system. .
2. Case analysis
The above is an overview process of computerized system activities. In order to better understand the computerized verification services provided, the following three cases are used to make specific interpretations.
Case 1
Computerized system compliance service An innovative biopharmaceutical company
· Purpose & Scope
Compliance service is a regulatory requirement for cGMP in the United States.
Prerequisite: A computerized system management system has been established
Requirements: On the basis of complying with regulatory requirements, the documents need to be integrated and optimized to ensure the guiding significance of the documents to management and operation. At the same time, a good record is designed to encourage the executives to carry out corresponding activities in accordance with the established regulations and serve as the carrier of original data.
·Service implementation
First, according to the whole process of the system life cycle, analysis requirements are in the operating stage of the system life cycle, so as to provide relevant service content. This involves:
-Audit and report (such as difference analysis report)
-Record/form sorting
-Document revisions, etc.
Case 2
Warehouse Management System (WMS) Service A CDMO company for antibody drugs
· Purpose & Scope
Comply with domestic and international mainstream GMP (China, Europe and the United States) requirements for computerized systems.
Requirements: Provide computerized system verification activities for WMS (Warehouse Management System) in two different plant areas.
· Service implementation
First, according to the whole process of the system life cycle, analyze the requirements in the project phase of the system life cycle, and then provide relevant service content. This involves:
-QPP Quality Project Plan
-VP verification plan
-FDS function design description
-HDS hardware design description
-DQ design confirmation
-RA risk assessment
-PAR Part11 compliance assessment and VSR verification summary report.
Case 3
ERP system verification service, an antibody drug CDMO company
· Purpose & Scope
Connect the ERP system (not verified in the early project phase) with the WMS system and use it to carry out GxP activities to realize paperless management of warehousing. And then carry out ERP system verification.
· Service implementation
First of all, according to the whole process of the system life cycle, analysis requirements are in the operating stage of the system life cycle, and then provide relevant service content. This involves:
-URS user requirements description
-VP verification plan
-RTM demand traceability matrix
-DS design description
-RA risk assessment
-IQ installation confirmation plan and report
-PAR Part11 compliance assessment and VSR verification summary report.
In the actual case execution process, it will be based on the actual situation of the enterprise (for example, the analysis system belongs to the first stage of the life cycle, etc.), and the content that meets the actual situation of the enterprise and can be implemented is formulated.
3. Computerized system compliance services
1. Computerized system construction
Establish or review various SOP documents, and propose amendments to the review documents. For example, include:
-Computerized system management procedures
-Computerized system risk assessment procedures
-Computerized system supplier management procedures
-Data risk assessment procedures
-Data reliability
2. Computerized system verification
2.1 VMP (Validation Master Plan)
Create a list of computer-aided systems
For example, the overall project (including multiple factories), independent production workshops, QC laboratories, etc., based on these lists, prepare verification master plans.
Risk classification and identification of GMP key systems
Customize computerized system VMP based on customer document template
2.2 Software verification
It has successively provided software verification services for many domestic pharmaceutical companies and information technology companies to help companies establish a complete computerized system verification system. Services include:
-LIMS (Laboratory Information Management System) laboratory management system
-DMS (document management system) file management system
-MES (manufacturing execution system)
-EMS (Environmental monitoring system) environmental monitoring system
-ERP (Enterprise Resource Planning) enterprise resource planning system
-WMS (Warehouse Management System) warehouse management system
-QMS (Quality Management System) quality management system
2.3 Confirmation of Infrastructure Platform
The IT infrastructure platform system (for example: network, server, data backup system) is the basis for the operation of the application. As an integral part of computerized system verification, the validation of IT infrastructure systems must be validated before using the application system.