All Countries
Compliance
SOP Compliance Audit

SOP Compliance Audit Template for India

Create a bespoke document in minutes,  or upload and review your own.

4.6 / 5
4.8 / 5

Let's create your SOP Compliance Audit

Thank you! Your submission has been received!
Oops! Something went wrong while submitting the form.

Get your first 2 documents free

Your data doesn't train Genie's AI

You keep IP ownership of your information

Key Requirements PROMPT example:

SOP Compliance Audit

"I need an SOP Compliance Audit document for our pharmaceutical manufacturing facility in Mumbai, focusing on GMP compliance and including specific sections for laboratory operations and sterile manufacturing areas, to be implemented by March 2025."

Celebrated by
Collaborations with
Investors
Document background
The SOP Compliance Audit document is essential for organizations operating in India that need to verify and maintain compliance with their established standard operating procedures. This document type is specifically designed to conduct thorough assessments of SOP implementation and effectiveness while ensuring adherence to Indian regulatory requirements. It is typically used when organizations need to perform internal or external audits, during regulatory inspections, or as part of regular compliance monitoring programs. The document includes comprehensive audit protocols, compliance checklists, and evaluation criteria tailored to Indian legislative requirements and international best practices. It serves as a crucial tool for maintaining operational excellence and regulatory compliance, particularly in regulated industries where strict adherence to SOPs is mandatory under Indian law.
Suggested Sections

1. Executive Summary: High-level overview of the audit scope, major findings, and key recommendations

2. Introduction: Purpose of the audit, scope, and objectives

3. Definitions: Key terms and abbreviations used throughout the document

4. Audit Methodology: Description of audit approach, sampling methods, and evaluation criteria

5. Scope of Review: Detailed description of departments, processes, and SOPs covered in the audit

6. Compliance Assessment: Detailed evaluation of SOP compliance across different operational areas

7. Findings and Observations: Detailed presentation of audit findings, including both conformities and non-conformities

8. Risk Assessment: Evaluation of risks associated with identified non-conformities

9. Recommendations: Specific corrective actions and improvements suggested

10. Conclusion: Summary of overall compliance status and critical areas requiring attention

Optional Sections

1. Industry-Specific Compliance: Include when the organization operates in regulated industries like pharmaceuticals or food processing

2. Digital Systems Compliance: Include when evaluating SOPs related to digital systems and IT processes

3. Environmental Compliance: Include when assessing SOPs related to environmental management

4. Training Assessment: Include when evaluating SOP training programs and their effectiveness

5. Change Management Review: Include when assessing SOP revision and update processes

6. Quality Control Measures: Include for manufacturing or laboratory facilities

7. Remote Operations Assessment: Include when evaluating SOPs for remote work or distributed operations

Suggested Schedules

1. Appendix A: Audit Checklist: Detailed checklist used during the audit process

2. Appendix B: Non-Compliance Log: Detailed list of all non-compliance instances with severity ratings

3. Appendix C: Document Review List: List of all SOPs and related documents reviewed during the audit

4. Appendix D: Interview Log: Summary of interviews conducted during the audit

5. Appendix E: Photo Documentation: Visual evidence of findings where applicable

6. Schedule 1: Corrective Action Plan Template: Template for documenting corrective actions for identified non-conformities

7. Schedule 2: Risk Assessment Matrix: Detailed risk evaluation criteria and findings

8. Schedule 3: Compliance Statistics: Statistical analysis of compliance rates across different areas

9. Schedule 4: Follow-up Timeline: Proposed timeline for implementing recommendations and follow-up audits

Authors

Alex Denne

Head of Growth (Open Source Law) @ Genie AI | 3 x UCL-Certified in Contract Law & Drafting | 4+ Years Managing 1M+ Legal Documents | Serial Founder & Legal AI Author

Linkedin in social icon imageX social icon image
alex.den.21@genieai.co
Relevant legal definitions
Audit
Standard Operating Procedure (SOP)
Compliance
Non-conformity
Major Non-conformity
Minor Non-conformity
Observation
Corrective Action
Preventive Action
CAPA (Corrective and Preventive Action)
Quality Management System
Audit Evidence
Audit Criteria
Audit Scope
Audit Finding
Risk Assessment
Document Control
Version Control
Process Owner
Deviation
Root Cause Analysis
Audit Trail
Quality Records
Compliance Matrix
Control Measures
Effectiveness
Implementation Date
Internal Audit
Management Review
Objective Evidence
Quality Policy
Record Retention
Risk Level
Sampling Plan
Training Record
Verification
Work Instruction
Applicable Regulations
Authorized Personnel
Competent Authority
Documentation System
External Audit
Good Documentation Practices
Quality Metrics
Regulatory Requirements
Review Period
Validation
Clauses
Scope of Audit
Audit Methodology
Documentation Requirements
Confidentiality
Quality Management
Risk Assessment
Regulatory Compliance
Non-Conformity Management
Corrective Actions
Record Keeping
Training and Competency
Document Control
Change Management
Emergency Procedures
Health and Safety
Environmental Compliance
Data Protection
Reporting Requirements
Responsibility and Authority
Process Control
Equipment and Calibration
Internal Controls
Quality Metrics
Continuous Improvement
Dispute Resolution
Liability and Indemnification
Force Majeure
Intellectual Property
Termination
Governing Law
Relevant Industries

Pharmaceuticals

Manufacturing

Healthcare

Food and Beverage

Chemical Processing

Information Technology

Automotive

Aerospace

Banking and Financial Services

Biotechnology

Electronics Manufacturing

Research and Development

Logistics and Supply Chain

Relevant Teams

Quality Assurance

Compliance

Internal Audit

Operations

Production

Regulatory Affairs

Risk Management

Quality Control

Manufacturing

Process Excellence

Documentation Control

Health and Safety

Research and Development

Relevant Roles

Quality Assurance Manager

Compliance Officer

Internal Auditor

Quality Control Supervisor

Operations Manager

Regulatory Affairs Director

Process Excellence Manager

Plant Manager

Department Head

Quality Management System Coordinator

Risk Management Officer

Production Manager

Laboratory Manager

Chief Operating Officer

Manufacturing Director

Industries
Factories Act, 1948: Governs manufacturing processes and workplace safety procedures, which are crucial for SOPs in manufacturing facilities
ISO 9001:2015 Standards: Though not legislation, these standards are essential for SOP compliance audits as they provide the framework for quality management systems in India
Companies Act, 2013: Contains provisions for internal controls, audit requirements, and corporate governance which affect SOP documentation and compliance
Drugs and Cosmetics Act, 1940: If applicable to the industry, provides guidelines for SOPs in pharmaceutical manufacturing and quality control
Food Safety and Standards Act, 2006: If applicable to the industry, governs SOPs related to food safety and quality management systems
Information Technology Act, 2000: Relevant for digital documentation and electronic records maintenance in SOP systems
Quality Management System Guidelines IS/ISO 17025: Specifically relevant for testing and calibration laboratories' SOPs and their audit procedures
Environmental Protection Act, 1986: Relevant for SOPs related to environmental management and compliance procedures
The Standards of Weights and Measures Act, 1976: Important for SOPs involving measurement and calibration procedures
Labour Laws (various): Various labor laws that affect operational procedures and workplace safety SOPs
Teams

Employer, Employee, Start Date, Job Title, Department, Location, Probationary Period, Notice Period, Salary, Overtime, Vacation Pay, Statutory Holidays, Benefits, Bonus, Expenses, Working Hours, Rest Breaks,  Leaves of Absence, Confidentiality, Intellectual Property, Non-Solicitation, Non-Competition, Code of Conduct, Termination,  Severance Pay, Governing Law, Entire Agreemen

Find the exact document you need

Audit SOP

Standard Operating Procedure for conducting audits in compliance with Indian regulatory requirements and professional standards.

find out more

Procurement Internal Audit

An internal audit document for evaluating procurement processes and controls in organizations operating under Indian jurisdiction and regulatory framework.

find out more

Audit Program For Accounts Payable

A structured audit program for examining accounts payable processes and controls, designed in compliance with Indian regulatory requirements and accounting standards.

find out more

Supplier Audit SOP

A comprehensive SOP for conducting supplier audits in accordance with Indian regulations and international best practices.

find out more

Planning Analytics Audit

An Indian law-governed agreement for conducting professional audits of planning analytics systems and processes, aligned with ICAI standards and IT regulations.

find out more

Audit Program And Audit Plan

A structured audit planning document compliant with Indian regulatory requirements that outlines the strategy, methodology, and procedures for conducting an audit engagement.

find out more

Surprise Cash Count Audit Report

An Indian regulatory-compliant document recording the results of an unannounced cash verification process, including findings and recommendations.

find out more

Substantive Audit

An Indian law-governed agreement for conducting substantive audit services, outlining audit scope, methodology, and compliance requirements under Indian regulatory frameworks.

find out more

Substantive Analytics Audit

An Indian law-compliant agreement for conducting substantive analytics audits, covering audit methodology, data handling, and compliance requirements.

find out more

SOP Compliance Audit

A formal document for conducting SOP compliance audits under Indian regulatory framework, ensuring adherence to local legislation and industry standards.

find out more

Revenue Audit Manual

A comprehensive guide for conducting revenue audits in India, aligned with CAG regulations and national financial legislation.

find out more

Internal Audit Test Of Controls

A comprehensive internal audit control testing framework compliant with Indian regulatory requirements and international audit standards.

find out more

Internal Audit Substantive Testing

An internal audit substantive testing framework aligned with Indian regulatory requirements and ICAI guidelines, providing structured testing procedures for comprehensive internal audits.

find out more

Internal Audit Policy Manual

A comprehensive internal audit policy manual aligned with Indian regulatory requirements and professional standards, establishing guidelines for internal audit functions.

find out more

Financial Analytical Review

A comprehensive financial analysis document prepared under Indian jurisdiction, providing detailed assessment of company finances and strategic recommendations in compliance with local regulations.

find out more

External Confirmation Audit

A standardized audit document used in India for obtaining third-party verification of client information, following SA 505 and ICAI guidelines.

find out more

External Audit Manual

A comprehensive manual for conducting external audits in compliance with Indian regulatory requirements and professional standards.

find out more

Compliance Audit Manual

A comprehensive manual for conducting compliance audits under Indian regulatory framework, providing detailed procedures and guidelines for audit execution and reporting.

find out more

Checking Vouching And Audit Report

A comprehensive audit report documenting the examination of financial records and internal controls under Indian regulatory requirements.

find out more

Audit Test Plan

A structured plan detailing audit methodology and procedures in compliance with Indian regulatory requirements and ICAI standards.

find out more

Audit Test Of Details

An Indian-compliant audit testing template for documenting detailed examination of financial statement assertions under ICAI standards.

find out more

Audit Of Petty Cash

An audit document for evaluating petty cash management systems and controls in organizations under Indian jurisdiction, ensuring compliance with local regulations and accounting standards.

find out more

Audit Of Inventory And Warehousing Cycle

An Indian law-governed agreement for professional audit services covering inventory and warehousing operations, including verification procedures and compliance requirements.

find out more

Audit Of Cash And Bank Balances

An Indian-compliant audit document for verifying and reporting on an organization's cash and bank balances, following ICAI standards and RBI guidelines.

find out more

Audit Assertions For Payroll

A framework document for payroll audit assertions and compliance requirements under Indian jurisdiction, ensuring comprehensive payroll process verification.

find out more

Audit Assertions For Cash

A standardized audit document for verifying cash-related assertions and procedures under Indian accounting and regulatory framework.

find out more

Analytical Test Audit

An Indian law-governed agreement for analytical testing and auditing services, establishing testing procedures and quality control requirements.

find out more

Cash Verification In Bank Audit

A formal audit document for verifying physical cash holdings in Indian banks, governed by RBI guidelines and Banking Regulation Act, ensuring regulatory compliance and operational integrity.

find out more

Cash Count Audit Report

An Indian regulatory-compliant document that verifies and records physical cash holdings against recorded balances, including detailed count results and certifications.

find out more

Download our whitepaper on the future of AI in Legal

By providing your email address you are consenting to our Privacy Notice.
Thank you for downloading our whitepaper. This should arrive in your inbox shortly. In the meantime, why not jump straight to a section that interests you here: https://www.genieai.co/our-research
Oops! Something went wrong while submitting the form.

Genie’s Security Promise

Genie is the safest place to draft. Here’s how we prioritise your privacy and security.

Your documents are private:

We do not train on your data; Genie’s AI improves independently

All data stored on Genie is private to your organisation

Your documents are protected:

Your documents are protected by ultra-secure 256-bit encryption

Our bank-grade security infrastructure undergoes regular external audits

We are ISO27001 certified, so your data is secure

Organizational security

You retain IP ownership of your documents

You have full control over your data and who gets to see it

Innovation in privacy:

Genie partnered with the Computational Privacy Department at Imperial College London

Together, we ran a £1 million research project on privacy and anonymity in legal contracts

Want to know more?

Visit our Trust Centre for more details and real-time security updates.

Read our Privacy Policy.