Fortifying Integrity. Protecting Assets. Ensuring Absolute Compliance.

Table of Contents

1. Purpose

To establish a robust, compliant, and proactive framework for Security and Access Control that safeguards personnel, facilities, materials, documents, data, and systems from unauthorized access, theft, tampering, and misuse — while ensuring seamless operational continuity and regulatory compliance.

2. Scope

This SOP applies to:

All employees, contract staff, consultants, and visitors
All physical premises (manufacturing, warehouse, QC, QA, offices, utilities)
All digital systems (servers, databases, ERP, LIMS, EBR, document management systems)
All confidential information, records, and regulated materials

3. Objective

Protect company assets and sensitive information
Prevent unauthorized entry or system access
Maintain regulatory compliance (GMP, Data Integrity, IT Security standards)
Ensure accountability and traceability of access

4. Definitions

Access Control – Controlled authorization to enter physical areas or access digital systems.
Authorized Personnel – Individuals approved based on role and responsibility.
Restricted Area – Areas requiring controlled or limited access (e.g., server rooms, QC labs, warehouse).
Role-Based Access Control (RBAC) – System access granted based on job function.

5. Roles & Responsibilities

🔹 Management

Approve security policies and resource allocation
Ensure compliance with regulatory and legal requirements

🔹 Security Department

Monitor facility access and surveillance systems
Maintain visitor logs and entry records
Conduct regular security audits

🔹 IT Department

Manage system access, passwords, firewalls, and cybersecurity controls
Conduct periodic user access reviews
Immediately disable access for terminated employees

🔹 Department Heads

Approve access requests based on job necessity
Review and justify system access periodically

🔹 Employees

Protect ID badges and login credentials
Report suspicious activity immediately
Follow all access control protocols

6. Procedure

A. Physical Security Control

1. Entry & Exit Control

All personnel must display valid ID badges at all times.
Biometric or card-based access systems shall be used for restricted areas.
Security personnel verify visitor identity before granting entry.

2. Visitor Management

Visitors must:
- Sign the visitor register
- Present valid identification
- Wear visitor badges
- Be accompanied at all times in restricted areas
Visitor access is time-bound and area-specific.

3. Restricted Area Control

Access permitted only to authorized personnel for:

Manufacturing zones
QC/QA laboratories
Warehouses
Server rooms
Document archives

Access logs shall be maintained and periodically reviewed.

4. Surveillance & Monitoring

CCTV cameras installed in critical areas
Footage retained as per record retention policy
Periodic review for suspicious activity

B. Digital / System Access Control

1. User Account Management

Unique User ID for every individual
No shared login credentials permitted
Access granted based on approved access request form

2. Password Policy

Strong password requirements (minimum length, complexity)
Mandatory periodic password change
Automatic lock after failed login attempts

3. Role-Based Access Control (RBAC)

Access strictly aligned with job responsibilities
Least privilege principle applied
Segregation of duties maintained

4. Access Approval Process

Access request initiated by Department Head
Reviewed by IT and QA (if GMP-impacting system)
Documented approval before activation

5. Access Review

Quarterly review of all active users
Immediate revocation for:
- Employee resignation/termination
- Role transfer
- Extended absence

6. Data Protection

Antivirus and firewall protection enabled
Regular system backups
Encryption for sensitive data
Audit trails enabled for GMP-critical systems

C. Incident Handling & Breach Management

All security breaches must be reported immediately.
Incident investigation initiated within 24 hours.
Root cause analysis performed.
Corrective and Preventive Actions (CAPA) implemented.
Documentation maintained for regulatory review.

D. Training

Mandatory security awareness training for all employees
Annual refresher programs
Special training for IT and security personnel

E. Documentation & Records

The following records shall be maintained:

Access request forms
Access approval records
Visitor logs
CCTV monitoring logs
User access review reports
Incident investigation reports

Records retained as per Document Retention Policy.

7. Compliance & Audit

Internal audits conducted periodically
Findings addressed through CAPA
Non-compliance may result in disciplinary action

8. Key Principles

✔ Need-to-know basis
✔ Least privilege access
✔ Traceability and accountability
✔ Data Integrity and confidentiality
✔ Continuous monitoring and improvement

🌟 Conclusion

A strong Security and Access Control System is not just a policy — it is a commitment to operational excellence, regulatory integrity, and organizational trust. By implementing structured controls across physical and digital environments, the organization ensures protection of its people, products, and reputation.

❓ Frequently Asked Questions (FAQ)

1️⃣ What is the purpose of the Security and Access Control SOP?

The purpose of this SOP is to establish a structured and compliant system that protects facilities, systems, materials, documents, and sensitive data from unauthorized access, theft, tampering, or misuse while ensuring operational continuity and regulatory compliance.

2️⃣ Who is required to follow this SOP?

This SOP applies to:

All permanent and temporary employees
Contract staff and consultants
Visitors and vendors
IT and security personnel
Management and department heads

Compliance is mandatory for everyone accessing company premises or systems.

3️⃣ What is meant by “Role-Based Access Control (RBAC)”?

Role-Based Access Control (RBAC) means that access to systems or restricted areas is granted strictly based on job responsibilities. Employees receive only the minimum access necessary to perform their duties (least privilege principle).

4️⃣ How is access to restricted areas controlled?

Restricted areas such as manufacturing zones, QC labs, warehouses, and server rooms are controlled through:

ID badge systems
Biometric authentication
Access cards
Security personnel verification
Electronic access logs

Entry is limited to authorized personnel only.

5️⃣ What is the procedure for granting system access?

System access is granted through:

Submission of an access request by the Department Head
Review and approval by IT (and QA for GMP-critical systems)
Documentation of approval
Creation of a unique User ID

No access is provided without proper authorization.

6️⃣ Are shared login credentials allowed?

No. Shared login credentials are strictly prohibited. Each user must have a unique User ID to ensure traceability, accountability, and compliance with data integrity principles.

7️⃣ How often is user access reviewed?

User access is reviewed periodically (typically quarterly) to:

Remove inactive users
Modify access after role changes
Ensure alignment with current job responsibilities

Immediate revocation occurs upon employee termination or resignation.

8️⃣ What is the visitor access procedure?

Visitors must:

Present valid identification
Sign the visitor log
Wear a visitor badge
Be accompanied in restricted areas
Access only approved areas

Visitor access is temporary and monitored.

9️⃣ What should be done in case of a security breach?

In the event of a security breach:

Report immediately to Security or IT
Initiate investigation within 24 hours
Perform Root Cause Analysis (RCA)
Implement Corrective and Preventive Actions (CAPA)
Document the incident for regulatory compliance

Prompt reporting helps prevent escalation.

🔟 Why is periodic security training important?

Security awareness training:

Reduces risk of human error
Prevents data breaches and cyber threats
Strengthens compliance culture
Enhances overall organizational security posture

Training is mandatory and conducted at induction and annually.

1️⃣1️⃣ What records are maintained under this SOP?

Key records include:

Access request and approval forms
Visitor logs
CCTV monitoring logs
User access review reports
Incident investigation reports

All records are retained as per the Document Retention Policy.

1️⃣2️⃣ What happens if someone violates access control policies?

Non-compliance may result in:

Disciplinary action
Suspension of access privileges
Formal investigation
Regulatory consequences (if applicable)

Security compliance is a shared responsibility and critical to protecting the organization.

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