COMPLIANCE COLABERATIVE INSOURCING

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. Huddle group

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.