OUTSOURCED QUALITY ASSURANCE
REJIMUS specializes in improving quality operations for traditional Food & Beverage and Dietary Supplement companies. Our expert services help increase your part-time QA capacity, support seasonal trends, and ensure daily cGMP compliance. For small or virtual businesses without a qualified compliance officer, REJIMUS can provide the essential coverage you need.
Outsource Your Quality Assurance Functions with Confidence
By outsourcing your routine quality assurance functions to our dedicated team of compliance experts, you can access reliable and affordable services on a part-time or full-time basis. With REJIMUS, there’s no excuse for not having competent personnel in place. Our Outsourced Quality Assurance services guarantee that 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.
Flexible Part-Time Dedicated Outsourced QA Services
REJIMUS provides companies with part-time dedicated Outsourced QA services that remotely support the routine Quality Assurance and Quality Control functions of your business. Our services can complement in-house resources for overflow support or seasonal planning, or be established as a fixed resource to help control quality department costs.
Key Benefits of Outsourcing QA to REJIMUS:
• Minimal learning curve for assigned quality/regulatory specialists with regular training
• 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
• Secure remote client-side web-based access to Project Management system with embedded documentation controls
• Flexibility 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 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 (e.g., Training, Use logs, Cleaning logs)
• Documentation review for Certificates of Analysis, Batch Records, Manufacturing Records, etc.
• Management, qualification, and investigation of Product Complaints and AERs (excluding SAERs)
• 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. (excluding facility audits and physical inspections)
• Remote support for FDA Inspections and Customer Audits of clients’ operations
• Writing and Management of Quality Agreements 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. Contact us today to learn if outsourcing your Quality Assurance functions to REJIMUS is the right choice for your business.