QMS Packages

Gold

The Gold Package includes our entire suite of QMS documents customized for your company to meet FDA and other regulatory requirements.

14 Documents Included: Quality Manual, Document Control Procedure, Records Control Procedure, Corrective and Preventive Action (CAPA) Procedure, Change Control, Deviations Management Procedure, Nonconforming Material Procedure, Recall/Return Procedure, Complaints Procedure, Internal Audit Procedure, Personnel Qualifications Procedure, Risk Management Procedure, Supplier Qualification, and Master Validation Plan procedure.

8 Forms Included: Document Change Request Form, Equipment/Process Change Request Form, CAPA Form, Deviation Form, Nonconforming Material Form, Recall Initiation and Plan Form, Supplier Qualification Form/Questionnaire, and Complaint Form.

Consultation: Continued for 6 months, including document changes to versions.

E-mail or Call for Pricing: info@fdaqms.com or (707) 301-7411

Silver

14 Documents Included: Quality Manual, Document Control Procedure, Records Control Procedure, Corrective and Preventive Action (CAPA) Procedure, Change Control, Deviations Management Procedure, Nonconforming Material Procedure, Recall/Return Procedure, Complaints Procedure, Internal Audit Procedure, Personnel Qualifications Procedure, Risk Management Procedure, Supplier Qualification, and Master Validation Plan procedure.

Forms: Not Included

Consultation: Continued for 3 months, includes document changes to versions.

Email or Call for Pricing: info@fdaqms.com or (707) 301-7411

Bronze

Number of Documents provided based upon need/request. Choose from 1-14 of the QMS documents and/or Forms listed in the Gold or Silver packages.

E-mail or Call for Pricing: info@fdaqms.com or (707) 301-7411

Audit

The audit package consists of the documents needed to implement an internal or supplier audit program. The package includes:

  • Internal or Supplier Audit Procedure

  • Internal or Supplier Audit Schedule Template

  • Internal or Supplier Audit Plan Template

  • Risk Assessment Template

  • Audit Report Template

  • Audit Schedule Template

E-mail or Call for Pricing: info@fdaqms.com or (707) 301-7411