Validation Services
Benchmark Quality Systems has the capability to deliver Validation/Qualification support across a diverse range of quality intensive industry sectors,
Pharmaceutical Operations
Medical Device Manufacturing
Hospital Facilities
Laboratories
Health Science Facilities
Blood and Tissue Bank operations
Quality Critical Industrial Operations
Defence System Manufactures
In today's highly regulated industries, the importance of robust validation and qualification services cannot be overstated. Our comprehensive suite of services ensures that your equipment, processes, and software meet the stringent standards of regulatory bodies. With a proven track record in pharmaceuticals, biotechnology, and medical devices, we offer tailored solutions that encompass commissioning, qualification, and validation, guaranteeing that your operations are efficient, compliant, and ready for any audit. Trust in our expertise to maintain the integrity of your quality management system and safeguard the success of your products.
The Basics of Validation
What is Validation
Validation is the establishment of documented evidence that a system/processes is consistently delivering the required outcomes as intended.
Fundamentally, it is a systematic program that can withstand competent technical scrutiny. The outcome being a high degree of assurance that specific processes, methodologies, systems, or individual equipment will produce results that meet a pre-determined set of acceptance criteria.
Effective validation relies on determination of the Critical Quality Attributes (CQAs) and Critical Process Parameters (CPPs) that are inherent in the system. Consistent process control requires tight regulation of these aspects. Secondly, and just as critical, is the data integrity that documents the system of compliance.
Why Validate ?
To demonstrate that the required quality standards are met.
To demonstrate compliance standards are met.
To demonstrate product efficacy standards are met.
To demonstrate safety standards are met.
To deliver economic assurance that processes will deliver the required efficiency.
Types of Validation
Process Validation.
Equipment Validation.
Validation of Cleaning Methods.
Method Validation – Project Systems and Execution.
Computer and Data System Validation.
Periodic Reviews.
The Core Elements and Steps of Validation
Define the Validation Strategy via a documented Validation Project Plans (VPPs).
Define the Verification Quality Strategies (VQS) by identifying and documenting the Critical Quality Attributes (CQAs) and Critical Process Parameters (CPPs) – The basis of validation testing.
Protocols – Installation/Operational or Performance protocoal are drafted/reviewed to define the testing methodologies.
Establish the acceptance criteria that demonstrate that the CQAs and CPPs are regulated/controlled. This is based on science, technology and regulatory requirements for the equipment/process.
Responsibilities/accountabilities are defined and documented.
Data integrity compliance is assessed– inspection readiness.
Applicable Procedures that define standard operating methodologies are reviewed.
Deviation procedure to define corrective actions is applied.
Conclusions are documented.
Review and Reporting - Protocols are reviewed and the outcomes are documented in a concise report.
What is Verification
Verification is the application of test methods/procedures that evaluate, monitor, or if possible, quantify the control measure that demonstrate that operating systems are delivering outcomes that are in accordance with pre-defined criteria.
What is Qualification
Qualification is action or a set of tests that establish that equipment or ancillary systems are installed and operate as intended. Qualification must also establish that effective control measures are in place to ensure that continued operation will consistently deliver the expected results.
Qualification is part of validation, but the individual qualification steps alone do not constitute process validation.