Audit Services
Blackfield Associates provides international Audit Service solutions to regulated industries, primarily the Life Sciences industry including Pharmaceutical, Biologics and Medical Devices.
Our service is tailored to customer needs and addresses bottlenecks of delivery timelines. We support and provide several different solutions for the clients we partner with;
- Remediation Audit/Consultancy
- Vendor/Supplier Assurance
- Inspection Readiness
We support customers to achieve the highest level of quality by ensuring the end-to-end experience is best in class for both auditor and customer.
Lifecycle
At Blackfield Associates, we support the full project lifecycle of both client and auditor in partnership. To ensure we deliver the best experience, we provide a fully tailored, fit for purpose solution. These solutions include:
- Onboarding
- Consultation
- Qualification
- SharePoint
- Reporting
- Delivery
- Review
Industry SME
We operate as an inch wide and mile deep solutions business. As such our auditors are industry SMEs, ranging from Senior to Principal level, auditing to the following standards:
- GxP – GMP, GDP, GCP, GVP
- ISO 9001
- ISO 13485
- MDD/MDR
- IVD/IVDR
If you would like to discuss our Audit Service solutions further with a consultant, please email audit@blackfieldassociates.com
