The Core Quality Systems Pack: Audit-Ready Templates for Deviation, CAPA, Change Control & Audits

Is your Quality Management System struggling with the most critical feedback loops? In any FDA or regulatory inspection, the systems that manage deviations, CAPAs, change control, and internal audits are the first to be scrutinized. A weakness in these areas can lead to significant audit findings, demonstrating a lack of control over your processes and an inability to drive meaningful improvement.

The Core Quality Systems Pack is your targeted solution to build a robust and defensible compliance framework. Stop patching together inconsistent procedures and implement a proven, interconnected system for managing quality events.

Key Benefits:

• Strengthen Compliance: Implement the foundational procedures that FDA investigators and auditors expect to see, demonstrating a mature and proactive approach to quality management.
• Drive Improvement: Establish a powerful engine for continuous improvement by effectively investigating deviations, identifying true root causes, and implementing meaningful Corrective and Preventive Actions (CAPAs).
• Manage Change Effectively: Implement a robust change control system to ensure that all planned changes are properly assessed, documented, and executed without introducing unintended risks to your product or processes.
• Enhance Oversight: Use the internal audit templates to proactively identify gaps in your QMS before they become major compliance issues.

What's Included in the 9 Document Pack?

This bundle provides all the necessary SOPs and Forms to establish the most critical feedback systems required by 21 CFR Part 211, including:

• SOP-QS-001: Deviation Management and Investigation
• SOP-QS-002: Change Control Management
• SOP-QS-003: Corrective and Preventive Action (CAPA) System
• SOP-QS-004: Internal Audit (Self-Inspection) Program
• SOP-QS-005: Product Complaint Handling
• SOP-QS-006: Product Recall Procedure
• FORM-QS-001: Deviation Report Form
• FORM-QS-002: Change Control Request Form
• FORM-QS-003: CAPA Plan Form
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Who is this for?

This package is ideal for biotech and pharmaceutical companies that already have a basic QMS but need to urgently implement or significantly improve their core quality systems. It is the perfect solution for Quality Managers and Compliance leaders tasked with preparing for an upcoming audit or addressing existing gaps in their deviation, CAPA, or change control processes.

Important Disclaimer: Your Role in Implementation

This documentation pack provides a comprehensive set of templates designed to serve as a strong foundation. It is not a ready-to-use, off-the-shelf system. Each template must be reviewed and updated by your organization to accurately reflect your specific processes and personnel.

While these documents are authored based on deep industry experience and cGMP principles, you are ultimately responsible for ensuring your final, implemented procedures are compliant with all applicable regulations. We do not guarantee that these templates are "audit-proof" as-is. We strongly recommend a final review by your internal Quality Unit or a qualified consultant before implementation.