Validating pharmaceutical systems
Depending on your specific needs, Pro Pharma Group designs project teams with specific skill-sets to provide an adaptable service. You benefit from the least burdensome, yet most cost-effective and successful validation approach.
We apply best practices to the configuration, design, and implementation of quality management systems (e.g., change control, CAPA, document control, Delta V BAS, and LIMS), as well as to the additional systems used in the manufacturing of the product.
Computer software, as part of the computer system, dictates the hardware on which to be executed.
The software categorization typology in GAMP5 ranges from infrastructure “used-by-millions” software (category 1) such as antivirus software, operating systems (e.g., Windows, Linux, Unix, etc.), and databases (e.g., MS SQL, Oracle), to non-configured software with a large user base (category 3) such as firmware and MS Office applications, to customized software (category 5) (i.e., software characterized as being one of a kind such as most process controllers, scripts, macros, and data interfaces).
Fortunately, top management, quality executives, and engineers are becoming more aware of potential regulatory pitfalls and breaches as the industry becomes familiar with computer systems and generated data. FDA, 21 CFR 11, Electronic Records; Electronic Signatures 2.
As technology increases, so does risk for non-intended use and ultimately non-compliance.
Regulatory focus is primarily on raw data, data integrity, and SOPs (i.e., procedures not compromising the inteded use and, ultimately, the raw data).
Because of this attitude, users may rely too heavily upon vendor-supplied information and validation data to support their system validation.
Relying on vendor-supplied data could compromise the intended use of the software, and therefore, compromise the validation.Guidelines, recommendations, hands-on frameworks and templates, including the extent of validation and the type of documentation required to support validation, are unclear (2-8).