Audits

Audits, inspections and site visits

We perform audits for the IT system Part 11 and annex 11 compliance / GAMP5 compliance, as well as overall security and functionality assessments to ensure your IT system serves with best possible manner. Depending on your needs we can focus on computers systems, personnel or documentation and benchmark your status to comparable systems.

An external GXP-IT audit may be required before clinical inspection to see that data management and storage are in sufficient level - following gap-analysis may reveal additional needs for further development or training. In addition we can perform pre-contract and vendor audits.

We provide you with auditing services in Finland, within EU or overseas

All audits start with detailed planning

• Before audit we will draft audit plan with the customer, including detailed cost and time estimations.

• We'll identify the key personnel that should be present and prepare adequate time with them for the audit.

• During the audit we focus on the essential aspects of the assigment, still keeping eye for improvements
• After audit we prepare detailed report, have a draft review and final report soon available in paper and electronical format
• Based on our findings on audit, we will recommended corrections and additional tips and guides how to develop and improve the system to perform with maximal efficiency to ensure lower maintenance costs
  Corrected actions can be reviewed with a shorter post-audit inspection with a supplementary notes to the previous audit

IT Network Security
Compliance to GAMP5 / CFR part 11
Pre-contract audits
Vendor audits
IT Policies and documents
Process efficiency
Data management and storage
Biomanufacturing GMP environment