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.
Process Validation for Pharmaceutical Manufacturing
The CGMP regulations require that manufacturing processes be designed and controlled to assure that in-process materials and the finished product meet predetermined quality requirements and do so consistently and reliably. Process validation is required, in both general and specific terms, by the CGMP regulations in parts 210 and 211
Process Validation for Medical Device
Validation of medical devices is mandated within the; FDA 21 CFR part 820. These form part of the Quality System Regulations established by the U.S. Food and Drug Administration (FDA) to direct Medical Device manufacturers and ensure that their products consistently meet applicable requirements and specifications.
Equipment and Instrument Validation
Qualification of analytical instruments and validation of systems is required by many national and international regulations, quality standards such as ISO 17025 and company policies. If executed correctly, it also helps to improve instrument uptime and to avoid out-of-specification situations (OOS) in laboratories.
Computer System Validation
Computer System Validation is the technical discipline that Life Science companies use to ensure that each Information Technology application fulfills its intended purpose. Stringent quality requirements in FDA regulated industries impose the need for specific controls and procedures throughout the Software Development Life Cycle (SDLC). Evidence that these controls and procedures have been followed and that they have resulted in quality software (software that satisfies its requirements) must be documented correctly and completely.