Computer System Validation (CSV) Audit Support Services
Are you applying critical thinking to your CSV audit programme?
We provide a pragmatic, risk-based approach to help you align with regulatory requirements, and define and execute a CSV audit strategy across your audit universe
Let us manage your internal and external CSV audit and assessment program by supporting the planning, execution, reporting and CAPA planning. Our audit team has extensive experience of process, project, internal system, SaaS, AI System, and vendor audits. Our global footprint means we can supply auditors from various locations to minimize the cost of travel for on-site audits. We apply a risk-based approach to ensure an appropriate assessment, whether that be remote assessment or on-site audits.
Why Choose Our Company for Your CSV Audit Services?
Experienced Lead Auditors: Extensive experience with both CSV Auditing, as well as practical CSV and Data Integrity application
GxP CSV Audit Specialist: Our auditors can cover all types of GxP CSV Audits
Risk Based Approach: We understand the value of auditing and help our customers mitigate risk and protect their businesses
Global Footprint: As a proud member of ProductLife Group's global Consulting & Digital Team, our auditors cover North America, Asia, and Europe
Remote or On-Site Audit Flexibility: We have experience with both remote and on-site audits
Do you need to audit a vendor or internal Computerized System?
Core CSV Audit Service Offerings
Complete end-to-end management of your Audit Program for both internal and external audit candidates, including the creation and maintenance of the CSV audit universe, audit planning, audit execution, and CAPA Management.
Follows industry best practice covering both internal and external audit candidates (ie Audit Universe). We’ll work with you to design & implement an Audit Strategy that is based on risk factors. This includes reviewing and providing recommendations to your existing Audit Strategy.
Each entry of the audit universe (audit candidate) is assessed for risk factors applicable according to your Audit Strategy. Based on this risk assessment, we help you identify High, Medium & Low risk audit candidates. We’ll develop an audit plan that ensures High risk candidates are audited annually.
Based on the capabilities of the existing client audit team we can either manage the whole audit plan or supplement this with our audit team. Our audit team can be trained on your procedures & templates or we can offer PLG Audit templates to allow deployment in a standardised way.
Effective Corrective and Preventive Action (CAPA) support ensures continuous improvement. We can provide CAPA management and re-run of the risk factors on a frequency determined in the Audit Strategy.
Looking for help with something not listed above? Don’t hesitate to reach out.
Our team can also provide cross-functional support across other departments
Looking for help with something not listed above? Don’t hesitate to reach out.
Our team can also provide cross-functional support across other departments
Managing CSV Audits doesn't have to be overwhelming
“Our team has performed over 300 audits to date. We can help you fill resource and expertise gaps, and take the stress out of the CSV audit process. With our risk-based audit approach and extensive global footprint, we can streamline your audit processes, reducing costs and ensuring high-quality assessments. Whether your audits are remote or on-site, our team ensures consistency and thoroughness every step of the way.”
Søren Winkel
Global Head of PLG Consulting & Digital Business Unit
Co-Founder at Pharma IT
Managing CSV Audits doesn't have to be overwhelming
“Our team has performed over 300 audits to date. We can help you fill resource and expertise gaps, and take the stress out of the CSV audit process. With our risk-based audit approach and extensive global footprint, we can streamline your audit processes, reducing costs and ensuring high-quality assessments. Whether your audits are remote or on-site, our team ensures consistency and thoroughness every step of the way.”
Søren Winkel
Global Head of PLG Consulting & Digital Business Unit
Co-Founder at Pharma IT