Validation & Qualification
Validation and Qualification Areas of Expertise
From validating software and processes to commissioning and qualifying equipment and utilities, MEDVACON experts can help safeguard your facilities and systems to ensure that they remain compliant.
Commissioning & Qualification
Facilities and utilities commissioning and qualification are essential processes within regulated industries, such as pharmaceuticals, biotechnology, medical devices, and food manufacturing. These processes involve a series of systematic activities that ensure the proper design, installation, operation, and performance of critical infrastructure, equipment, and systems used in the production and distribution of products.
Computer System Validation
Computer Software Validation is a formalized, documented process for testing computer software and systems, required by 21 CFR 11.10(a) and Annex 11, Section 4. The FDA and other regulatory bodies require validation to demonstrate that computer systems are in compliance with all regulations for electronic data management systems.
Equipment Qualification
Equipment Qualification comprises a series of qualifications defining designs, installation, operational, and performance qualification assuring consistent and anticipated equipment functionality. Operating parameters and environment, documented routine maintenance, and continuous performance checks contribute to a life-cycle approach to maintaining equipment in a validation state.
Cleaning Validation
Cleaning Validation is equally important to manufacturing safety and continued compliance. MEDVACON provides our clients with manufacturing equipment cleaning validation process development and verification expertise to ensue uncontaminated equipment conditions during each manufacturing run.
Process Validation
Process Validation strengthens the production of pharmaceuticals. intermediate products, and manufacture of medical device manufacturing.
Aseptic Operations
MEDVACON will perform a targeted assessment or an overall end-to-end assessment of the aseptic manufacturing operation identified in the bullets below. For end-to-end assessments, MEDVACON Senior Consultants will observe manufacturing operations on all shifts over a multi-week period.