Computer System Validation (CSV) and Part 11 Auditing

The system of physical devices, software, and IT services you use to conduct your regulated business is complex. You may have bought some software off-the-shelf. Some of it may have been customized or built for you by an external software vendor, and some of it may have been developed internally. Some of your computing may be conducted in-house, performed by cloud applications, or outsourced entirely. Ultimately, you need to ensure that all your systems are secure, recoverable, validated, and properly maintained. You need to make sure your electronic records are trustworthy, and the electronic signatures they carry are genuine.

Polaris can conduct CSV audits of the software, infrastructure, and IT services your company relies on, whether at your premises or off-site at a vendor facility. Your audit can be comprehensive, or focus on a particular functional area, business operation, or computer system. We verify compliance with 21 CFR Part 11 and other FDA regulations and guidelines, Good Automated Manufacturing Practice (GAMP), ICH guidances, and Annex 11, if appropriate. We also assess other quality system elements and supporting processes including staff training, SOPs, document control, corrective and preventative actions, and problem reporting.