What Computer System / PLC Validation
The purpose of the validation process is to provide a high level of assurance that a given process (or computer system) will consistently produce control information or data that meets predetermined specifications and quality standards. This process ensures that the output is reliable and of the highest quality
Why Validation is required
Food and Drug Administration (FDA) regulations require companies to perform Computer System Validation, and these regulations are legally binding. If a company fails an FDA audit, they may face FDA inspectional observations (“483s”) and warning letters. If they do not take corrective action in a timely manner, the consequences can be severe, including the closure of manufacturing facilities, consent decrees, and hefty financial penalties. Ultimately, this could lead to job losses, the indictment of responsible parties (usually the officers of a company), and economic instability, resulting in downsizing and, in some cases, bankruptcy.
Validation objective to secure-
- Safety of Patient
- Product Quality
- Data integrity
Validation is an essential practice for
Reducing risk and legal liability in many industries and businesses, particularly those in the healthcare and other regulated sectors.
Validation provides documented evidence that computer systems are fit for purpose and operating correctly, which is a key component of good business practice. As software continues to evolve to meet the ever-growing demands of users, validation must be an ongoing process.
Validation applies to a variety of areas, such as services, equipment, computer systems, and processes. The goal of validation is to ensure that all parts of the facility will function correctly and consistently when put into use. Computer systems validation covers both new and existing systems.
Before you can validate a system, you need to identify the systems that require validation. To do this, you must analyze the following areas: 21 CFR Part 11 – electronic records and signatures; manufacturing processes; product release or stability information; regulatory information; and support of GxP activities. All users must be trained on current SOPs related to computer system development and validation.
- Project Plan
- Installation Qualification
- Operational Qualification
- Performance Qualification
VMP (Validation Master Plan)
A VMP, or Validation Master Plan, is an important document that outlines the strategies, procedures and documentation requirements used to ensure satisfactory performance of computerized systems in pharmaceutical production and other regulatory areas. It serves as a point-of-reference for all validation projects associated with the production activities and includes details on design qualifications, initial calibrations, operational requirements and a plan for system maintenance. A VMP must also provide clear definitions of key terms and responsibilities in order to identify each person associated with any related tasks. Pharmaceutical companies must adhere to all applicable regulations while producing safe products–a well-developed VMP helps ensure that this is achieved.
Validation Process Step
Establishment of Team for Validation, Teams will be responsible for the validation process
- Determine Validation Activities
- Validation activities are the exact details or activities that will be required for each of the steps in the validation process
- The output from this activity will be the Validation Plan
- Write the Validation Protocol
- Describes the procedure and the steps within the procedure that will be followed in order to validate the system
- The Validation Protocol must also provide a high level description of the overall philosophy, intention and approach
- Perform Qualification Activities
- Design, IQ, OQ, PQ
- Review Controls and Procedures
- SOPs (Standard Operating Procedures)
- Training procedures and Training records
- Certify the System
- This step is where you certify that the validation deliverables have met the
- acceptance criteria that were described in the Validation Protocol
- When you certify the system you should prepare a Validation Report
- The validation report should outline the details of the validation process
- What is CSV?
- What is PLC validation
- Validation Master Plan