OUTSOURCED QUALITY ASSURANCE
For companies in the traditional Food and Beverage or Dietary Supplement industries, REJIMUS can help improve your overall quality operations, increase QA capacity part-time, support seasonal trends and better ensure daily cGMP compliance. For small or virtual companies with no qualified compliance officer, we can provide that coverage.
Outsourcing routine quality assurance functions on a part-time or full-time basis to our dedicated team of compliance experts has never been more reliable or affordable. Literally you can not make an excuse not to have competent personnel in place. Outsourced Quality Assurance with REJIMUS helps to ensure budgets are maintained without risking non-compliance issues as required by 21 CFR Part 110 (21 CFR Part 117), 21 CFR Part 111.12, 21 Part 111.103, Part 111.105 and other applicable regulations.
We provide companies with part-time dedicated Outsourced QA services that remotely support the day-to-day routine Quality Assurance and/or Quality Control functions of clients’ businesses. Services can be an add on to compliment in-house resources for overflow support or seasonal planning, or established as a fixed resource to help control quality department costs.
Benefits of Outsourcing QA to REJIMUS:
• Minimal learning curve for all assigned quality/regulatory specialists w/ routine training
• Highly cost-effective flat low monthly rate with back-up qualified personnel assigned (6-month minimum term)
• Detailed Activity Reports across all assignees, projects and tasks to ensure ROI
• Remote and secure client-side web-based access to Project Management system with embedded documentation controls
• Flexible to meet increasing or changing quality operational demands and rapid response times to compliance matters
• Optimized quality system, documentation practices, and application of Best Compliance Practices that is 100% resistant to personnel turnover
Outsourced Quality job functions covered:
• SOP Writing/Reviews/Optimization
• Specification Writing and Reviews – for ingredients & finished products
• Documentation review and approval signatures – Training, Use logs, Cleaning logs, etc.
• Documentation review – for Certificates of Analysis, Batch Records, Manufacturing Records, etc.
• Management, qualification and investigation of Product Compliant and AER’s only (SAER’s excluded)
• Documentation and close out of Deviations or Out Of Specification (OOS) investigations (Phase 1 only)
• Coordination of adulteration and contamination investigations and troubleshooting with identified experts
• Vendor & Supplier Paper Qualification(s) – for manufacturing, co-packaging, distribution, storage, etc. (facility audits and/or physical inspections excluded)
• Remote support for FDA Inspections of Customer Audits of clients’ operations
• Writing and Management of QualityAgreements with assigned Vendors
REJIMUS’s Outsourced Part-time Equivalent (PTE) QA Solution is available for 3-month terms only, with a minimum 40 hour/month allocation. Contracts for Outsourced QA services begin on either the 1st or the 15th of each calendar month pending availability. All Outsourced QA programs typically have a one month lead time before initiation due to resource scheduling and program setup. Please contact us today to learn if outsourcing your Quality Assurance functions to REJIMUS is right for your business.