Validation of Computer Systems and Workbooks
Validate computer systems according to US FDA, EU Annex 11, ISO/IEC 17025 and equivalent guidelines. Focus on validation of computer system is increasing in local and international regulatory inspections. The computer system includes all the devices, the network components and the all software (including bespoke software) used to handle the GxP data need to be validated. Similarly; spreadsheets used to store data which is processed to get results also require validation
Computer System Validation
Although Computer systems include all the complementary equipment that supports the system as well as its users as a whole but softwares, specially customized softwares which are developed according to end-user’s need are responsibility of the organizations where these are deployed and used.
Therefore software part of a computerized system need to be validated that its managers have control over user operations and their security, results produced are traceable, consistent, reliable and will produce information meets regulatory requirements and complies the regulatory requirements.
Focus on validation of computer system is increasing in regulatory inspections both local and international. The computer system include all the devices, the network components and the software used to collect, process, record, report, store or retrieve the GxP data need to be validated. Besides this bespoke and non-standard software also require separate validations. Similarly; spreadsheets used to store data which is processed to get results also require validation. Our experts will validate according to US FDA and EU Annex 11 or equivalent guidelines.
Validation of elctronic spreadsheets
Spreadsheets (Microsoft Excel workbooks or others) are commonly used in production, quality assurance and quality control. Such spreadsheets are required to be validated. Our experts can document and validate the spreadsheets used within your organization.