Relying on vendor-supplied data could compromise the intended use of the software, and therefore, compromise the validation.
In addition, quality management of electronic signatures and electronic records (1) (i.e., data generated by computer systems) is also part of the overall quality management system.
Computer systems must comply with c GMP requirements, when used in these regulated environments.
Furthermore, all final articles intended to be in contact with food and raw materials utilized to make these products that are placed on the market should be in compliance with US FDA requirements.
Food contact materials are described in the Code of Federal Legislation (CFR) - 21 CFR 174 - 21 CFR 190.
The company’s products for computer validation, auditing and FDA submissions ensure that their clients meet all requirements for electronic records and electronic signatures.
Ofni Systems provides live desktop support for superior customer support and training.From an internal-external perspective, verification practices (e.g., validation strategy, proper risk assessment, establishment of design, user requirements, and subsequent verification of requirements) must be processed and reported internally to verify the intended use of the software.The software’s intended use must be implemented, and personnel training in everyday operations must be conducted.As continuous technology advancements, cloud computing, virtualized process control systems and manufacturing networks, including security, converge into a technology-driven, ever-adapting industry, so does the potential risk of non-compliance with both internal instructions as well as regulatory governance.Users responsible for computer systems in pharmaceutical environments have raised legitimate questions con-cerning perspectives, validation strategy, scope, and methods when validating these systems.The FDA publishes an internal Laboratory Investigation Bulletin (LIB) each month that is distributed to all FDA employees.