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Templates for Regulated Systems

Structured documentation aligned to real-world validation and QMS implementation—supporting everything from individual components to complete system frameworks.

Documents are maintained and updated to reflect changes in regulatory expectations, industry standards, and continuous improvement of structure and content.

 

All purchases include access to updated versions for 12 months from the date of purchase.

Updates may include structural enhancements, additional guidance, and alignment improvements across template sets.

User Requirements Specification (URS)

Defines structured user requirements aligned to real system use and regulatory expectations

AUD $39

Traceability Matrix (TM)

Establishes linkage between requirements, risk, and verification activities

AUD $39

Starter Templates

Focused templates designed to support initial implementation of key validation components. These documents provide structure but require alignment with broader system elements.

Computer System Validation (CSV) Plan 

Provides a high-level validation planning framework aligned to system complexity and risk

AUD $29

QMS Sampler Pack

Includes essential documents to support basic governance, control, and compliance activities.

AUD $349

QMS & CSV Template Packs

Each pack represents a complete governance framework for a specific quality system area. Packs can be implemented independently or alongside existing systems, depending on organisational needs.

Core Quality Systems
Change Control Pack

Structured, risk-based framework for managing changes within quality management systems, supporting controlled evaluation, approval, implementation, and closure of change activities.

Includes:

  • Change Control Procedure 
  • Change Request Form
  • Change Control Register

These documents collectively support consistent, traceable, and audit-defensible change control practices across quality-critical activities.

AUD $999

Specialist & Expansion Systems

Additional governance frameworks for organisations with increased operational complexity, regulatory exposure, or specialised functions.

Data Integrity Pack

Structured framework for managing data integrity controls, including data mapping, control assessment, audit trail review, and backup and recovery practices.

Includes:

  • Data Integrity & Compliance Procedure
  • Data Integrity Risk Assessment
  • Data Integrity Control Assessment
  • User Access & Privilege Review Record
  • Backup, Retention & Recovery Assessment Record

AUD $1,399

Internal Audit Pack

Framework for governing audits and self-inspection activities aligned with objective regulatory review.

Includes:

  • Audit Procedure
  • Annual Audit Schedule
  • Audit Plan
  • Reporting Template
  • Deficiency Tracking

AUD $1,099

QC & Laboratory Pack

Governance framework for QC and laboratory oversight, including risk-based control and review processes.

Includes:

  • Governance Procedure
  • Risk Assessment
  • Control Assessment
  • OOS / OOT Record
  • Analytical Method Record
  • Data Review Record

AUD $1,299

If we don't have what you need, let us know & we'll create it for you ...

CAPA / Deviation Pack

Framework for systematic investigation, root cause analysis, and resolution of quality events.

Includes:

  • Deviation & CAPA Procedure
  • Deviation / Non-Conformance Report
  • CAPA Action Plan & Effectiveness Record
  • CAPA Register

AUD $1,499

Production & Cleaning Pack

Framework for overseeing production controls, cleaning validation, and full manufacturing traceability.

Includes:

  • Production Procedure
  • Cleaning Validation Plan
  • Protocol Template
  • Sampling Plan
  • Summary Report

AUD $1,199

Designed for organisations that need structured systems—not just documents.

Supplier Management Pack

Governance for formal supplier approval, risk-based evaluation, and ongoing performance oversight.

Includes:

  • Supplier Management Procedure
  • Supplier Risk Assessment
  • Supplier Evaluation Form
  • Supplier Audit Template
  • Supplier Performance Log
  • Approved Supplier List (Register)
  • Work Instruction – Using Supplier Scorecards
  • Example Supplier Evaluation Criteria
  • Sample Supplier Scoring Model

AUD $999

Training & Competency Pack

Governance for personnel training, skill matrix management, and competency verification aligned to regulatory compliance.

Includes:

  • Training & Competency Procedure
  • Training Record
  • Training Matrix / Register
  • Competency Assessment Record

AUD $1,199

Validation Master Pack

High-level governance framework for validation activities across computerised systems and facilities.

Includes:

  • Validation Master Procedure
  • Validation Master Plan (VMP)
  • System / Equipment Risk Assessment
  • Validation Plan
  • Validation Summary Report

AUD $1,099

Bonus !

 

Our documents are actively maintained to reflect changes in regulatory expectations, industry standards, and ongoing improvement of structure and content.

 

All purchases include access to updated versions for a period of 12 months from the date of purchase.

Templates provide structure, but effective implementation depends on system context, risk, and regulatory expectations.

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