Digital Transformation in Validation Process
GoValidation is a comprehensive Validation Life Cycle Management system (VLMS) software application that can help pharmaceutical industry to fulfil FDA CFR Part 11 and EU Annex GMP guidelines for Computer System Validation (CSV). GMP directives. GoValidation also helps to implement GAMP5 guidelines for the medical device manufacturers.
The system provides risk-based approach to CSV that includes business requirements and technical specifications to go through risk assessment process. The key focus of GoValidation are regulatory compliance, process effectiveness and cost savings from using paperless system.
What is Computer System Validaiton (CSV) ?
Computer System Validation (CSV) is a documented process that is required by regulatory agencies such as FDA to verify that a computer or a data processing system is validated for its intended use as per the established protocol. The validation processes and the results are documented electronically and approved with electronic signatures (e-sign) before the system is put into production usage. Annex 11 from European Medicines Agency (EMA)’s Good Manufacturing Practices (GMP) defines the directives for computerized systems used in pharmaceutical industry.
The following FDA 21 CFR Part 11 regulatory compliance indicates dictates on maintenance of electronic records.
- Persons who use systems to create, modify, maintain, or transmit electronic records shall employ procedures and controls designed to ensure the authenticity, integrity, and, when appropriate, the confidentiality of electronic records. Such procedures and controls shall include validation of systems to ensure accuracy, reliability, consistent intended performance, and the ability to discern invalid or altered records.
- The 21 CFR part 820.70 FDA compliance establishes the need for CSV to validate computer software.
- When computers or automated data processing systems are used as part of production or the quality system, the manufacturer shall validate computer software for its intended use according to an established protocol. All software changes shall be validated before approval and issuance. These validation activities and results shall be documented.
- The regulatory agencies require pharmaceutical manufacturing, clinical trial and medical device manufacturing companies to perform CSV for their production systems that use computers or any data processing equipment
Features
GoValidation provides the options to maintain various stages of Validation Life cycle and provide an option to store electronic records. The application workflow mechanism can be used bring relevant validation artefacts to go through review-approval work flow. The users can electronically sign the validation processes and artefacts as part of review / approval process.
The key artefacts that are the part of GoValidation application suite:
- Change control process
- GxP Impact assessment
- Validation project setup
- Project plan
- User Requirement Specification (URS)
- Functional/Design Specifications
- Risk assessment
- Test case creation and execution with deviation management
- Electronic review and eSignature
- Traceability Matrix
- Validation summary reports
- Periodic review
Adapting to GoValidation
GoValidation provides comprehensive and user-friendly features to handle validation tasks with ease. We help the customers in implementing Validation process using GoValidation in paperless way. Our approach towards to have solid paperless system can be done in the following steps.
Identify the system to be validated: If the system is regulated by organization’s Quality Management (QM), then the system should be validated.
Project Scope / Plan: A high-level plan can define the scope of validation – parts of the system to be validated, deliverables, and process documentation required.
Requirements: The requirements of computer/software/or any data processing system must be documented. The stakeholder requirements and system requirement specifications (functional / non-functional) should also be documented.
Risk Management Perform risk-based approach to identity the risks associated with requirements and specifications. For each risk, the mitigation plans and testing requirements must be identified. The users can create test cases to address / test the mitigation plans.
Test Cases/Scripts: The test cases / scripts to validate the system should be documented / reviewed. The test execution details and results should be documented.
It’s an important for any organization to maintain robust, risk-based Validation system is in place to meet out quality standards and regulatory compliances. The organization can avoid poorly designed systems and various regulatory actions due to non-compliance of validation processes.
If you have additional questions about CSV processes or would like to discuss about our VLMS software application GoValidation, please feel free to contact us for a consultation.