Du All Controls, LLC


Your Partners in Compliance


Our Mission

It is our mission to provide the very best of service to our clients by following a Risk Based compliance approach.  Providing our clients with a compliant process without breaking the bank.  We strive to be the very best in our industry by staying up to date with the FDA rulings, industry best practices and ongoing training.   Our clients are our partners in compliance.

Our systems experience spans IT, Lab and Process Automation

Background

We have 30+ years experience in the pharmaceutical and medical device industry. Our Expertise includes auditing, FDA compliance, Computer System Validation, 21 CFR Part 11, IT Security, investigations, customer product complaints, SOP development and assessment, PDMA, cGMP, and document control, following GAMP 5 procedures.

Main Service Items

For Complete Listing see our Services page

  • Oracle and SAP Enterprise Resource Planning (ERP) Systems.

  • Quality Systems FDA Reg. 820

  • Q7A & cGMP FDA Reg. 211

  • Electronic Records Electronic Signatures FDA Reg. 11

  • Prescription Drug Marketing Act FDA Reg. 203 & 205

  • QSIT Qualified Auditor's

    • Internal Audits (Pre FDA) or Other

    • External Audits (Vendor) or Other

  • CSV Validation

  • Cleaning Validation

  • Equipment Validation

  • Process Validation

  • SOP Creation & Guidance

  • Corrective And Preventative Actions (CAPA)