Process, Design, and Equipment Validation

Leaders in 21 CFR 11 Compliance and Software Validation Projects, Assessments and Training

Need Validation Help?

Process, Design, and Equipment Validation are the formal processes for establishing objective evidence that systems consistently produce results or products meeting predetermined specifications, as required by the Federal FD&C Act and cGMP. Validation is an excellent tool to understand and maximize value from your business processes. Validation is also a compliance issue; the FDA requires validation to demonstrate that processes, designs and systems are in compliance with all regulations for Quality Systems. Failure to validate systems is one of the leading reasons a business is issued a 483.

Process Validation

Process Validation applies to the production of pharmaceuticals and intermediate products. Per the FDA Process Validation Guidance, “process validation is defined as the collection and evaluation of data, from the process design stage through commercial production, which establishes scientific evidence that a process is capable of consistently delivering quality product.” This entails on-going documentation and assessment of all constituent elements of the process, such as materials, equipment, operations, and environmental conditions. The primary goal is to gain understanding and control of process variation and its effect on process outcome.

Design Validation

Design Validation is the establishment by objective evidence that device or equipment specifications conform with user needs and intended use. This can apply to manufactured medical devices as well as equipment used in the production of pharmaceuticals. Design validation may include actual- or simulated-use testing and requires software validation and risk analysis, where appropriate.

Equipment Validation

Equipment Validation comprises a series of qualifications, such as Design, Installation, Operational, and Performance Qualification, that provide a high degree of assurance of the consistent, expected functioning of a piece equipment. Operating parameters and environment, as well as documented routine maintenance and on-going performance checks, contribute to a life-cycle approach to maintaining equipment in a validated state.

Process, Design, and Equipment Validation can interrelate and overlap, e.g., with a process validation requiring the use of validated equipment which, in-turn, requires design validation. Such relationships between the various modes of validation are the basis of Quality Systems and reinforce the purpose of regulatory oversight: to ensure safe and effective products to promote and protect public health.

Ofni Systems Validation Services

Ofni Systems validation specialists have experience working within the compliance requirements of established regulated companies. Our specialists are experts in industry validation standards and will produce validation documents which will meet or exceed your exacting standards. We can help you design Quality into all of your processes.

Ofni Systems uses FastVal to write validation documentation and execute Testing Protocols, which allows us to complete validation projects in 70% less time than traditional validation methods, with more time spent testing your software and less time preparing documentation. Our goal in all validation projects is to improve the quality and value of your computer system.

Ofni Systems can validate all of your systems and processes. We can provide any level of service required, from executing test scripts generated from your existing specifications to writing the entire validation package. Ofni Systems will perform risk assessments to focus the validation effort on the most appropriate sections of your system.

Ofni Systems Validation Methodology

Our validation experts will plan the validation approach and define the requirements. This includes identifying and describing the process or system, specifying parameters, and assessing the desired inputs and outputs. These requirements are documented as Functional and Design Requirements.

Once requirements have been outlined and documented, test plans are developed to demonstrate that all functional system requirements are met and the system is properly secured. Our validation professionals will document a testing protocol, designed to demonstrate that your system meets all of your business requirements, plus regulatory requirements outlined in 21 CFR Parts 210, 211, and 820. As appropriate, this includes installation qualifications (IQ), operational qualifications (OQ), and performance qualifications (PQ). Deviations, if they exist, will be reported and resolved.

Throughout the validation process, a Requirements Traceability Matrix is updated to ensure that all system requirements are addressed. If necessary, a formal risk assessment can be created to document decisions to focus validation testing. A Summary Report is also created at the end of the process to summarize any issues found during the validation project.

Additional Resources

Additional information is available on specific types of validation: