The QMS Foundation Pack: Essential Templates for Document Control & GMP Systems

For an early-stage startup, where do you even begin with GMP compliance? Before you can even think about manufacturing, you need a compliant system to create, approve, and control your documents. Without this foundational framework, every procedure you write exists in a state of non-compliance, creating significant risk for future audits and investor diligence.

The QMS Foundation Pack is the essential first step in building your Quality Management System. This targeted bundle provides the complete, expert-authored framework for your document control and overarching quality systems. It gives you everything you need to start authoring your own SOPs in a controlled, logical, and audit-ready manner, establishing a solid foundation upon which the rest of your QMS can be built.

Key Benefits:

• Establish Control from Day One: Implement the most critical procedures for document control, GDP (ALCOA+), and records management, ensuring your documentation is compliant from the very beginning.
• Build a Solid Foundation: Use the Quality Manual and core QMS procedures to establish the high-level framework that will govern your entire quality system.
• Accelerate All Future Documentation: By having a compliant "SOP on SOPs" in place, you can confidently and efficiently develop all your other process-specific procedures.
• Demonstrate Credibility: Show auditors and investors that you have a professional and compliant system for managing your quality documentation, even at an early stage.

What's Included in the 12 Document Pack?

This bundle provides the complete set of SOPs, Policies, and Forms for the two most foundational parts of any QMS:

• Part 1: Quality Management System (QMS): Includes the Quality Policy, Data Integrity Policy, Quality System Manual, and procedures for Management Review and Risk Management.
• Part 2: Documentation and Records Management (DOC): Includes all SOPs for document creation, approval, control, distribution, GDP, records retention, and logbook management.

Who is this for?

This package is the perfect starting point for very early-stage biotech and pharmaceutical startups that need to establish their foundational quality system. It is ideal for founders, consultants, and the first quality hire at a company that is just beginning its journey toward GMP compliance.

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 that your final, implemented procedures comply with all applicable regulations. We do not guarantee that these templates are "audit-proof" as-is.