COMPLIANCE COLABERATIVE INSOURCING FOR LIFE SCIENCES
Pilothouse Advisors RCG practice offers highly skilled and experienced Senior Consultants who can help you become complaint with the FDA. We can provide assessments, audits, computer system validation, remediation and training in this highly complex environment of FDA compliance. We are very experienced in FDA Compliance in the Product, Manufacturing and Information Technology sectors.
Using our project teaming methodology of Collaborative Insourcing, our team works with your team in a project initiative deliverable format, organized by our team leads.
Let our consultants help you get complaint with the FDA.
Quality Management and Compliance Support
Quality System Development
FDA Electronic Records and
Electronic Signatures Regulation
Audits
Assessments
Remediation
Validations both internal and suppliers
Computer System Validation
Compliance Training
GxP
21 CFR 11
IQ/OQ/PQ/SOP
Remediation
Compliance Training
Ensure a robust CAPA process
Standardize templates created, reviewed and approved Computer System Validation (CSV)
GxP
Audits
Assessments
Validation , internal and suppliers
We would welcome an opportunity to discuss how the cadre of experience, skills, and tools we bring to the table can best serve your needs. Contact an Advisor for your complementary no-obligation discovery session.