Computer System Validation (CSV)
and 21 CFR Part 11 Compliance 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 as genuine as hand-written signatures.

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, record retention, and problem reporting.

Not sure you need an audit? Maybe you just need some advice. You might like to read about our computer systems consulting services.