AUDIT, COMPLIANCE & RISK MANAGEMENT

What Is It ?

Audit, compliance, and risk management is a systematic quality assurance activity that regularly evaluates the compliance of all quality processes in a business with regulatory requirements, GMP principles, and customer expectations, identifies deficiencies, and plans improvements.
This project ensures that your business has a ready, controlled and strong structure in both authority and customer audits.

Why Is It Necessary ?

- Most non-compliance issues in the pharmaceutical, dietary supplement, and traditional and herbal product sectors stem from documentation, record management, process control, and traceability.
- Businesses with compliance issues face risks such as:
-- finding issues during audits,
-- product withdrawal,
-- sales suspensions,
-- customer loss,
-- and export rejection
- Failure to conduct regular internal audits creates critical blind spots in the business.
- When risk management is not implemented, quality issues that are “noticed after the problem has grown” disrupt operations.
- For businesses that manufacture or outsource manufacturing, compliance is a fundamental element of commercial sustainability.
In short: Companies with weak compliance systems struggle during audits and lose their quality reliability.

How We Do It ?

Internal Audit (GMP & Regulatory)
- Facility, documentation, process, equipment, cleaning, and quality system audit
- Classification of nonconformities (critical–major–minor)
- Audit report and recommended actions
- The plan to make it ready for audit

Supplier Audit & Contract Manufacturing Audit
- New supplier audit
- Periodic compliance audit of existing suppliers
- Quality system audit at contract manufacturing facilities
- Supplier risk scoring

Pre-Audit Preparation
For TITCK, authority, customer, or export authority audits:
- Document and record preparation
- Process area assessment
- Personnel guidance & training
- Audit scenarios & question management

Post-Audit Improvement Management
- Root cause analysis of nonconformities
- Corrective and Preventive Action (CAPA) planning
- Effectiveness verification
- Systemic improvement recommendations
- Closure reporting

Risk Management (Product, Process, Supply, Organization)
- Risk analysis (FMEA, HACCP, 5M vb.)
- Identification of critical control points
- Process risk reduction plan
- Product safety risk management
- Supply chain risk assessment

Is It Necessary For You ?

If even one of the following questions is "Yes", audit & compliance management support is critical for you:
1 - Are you preparing for an upcoming TITCK, customer, or any other authority audit?
2 - Is your internal/external audit system inadequate, irregular, or non-existent?
3 - Are you unsure about the suitability of the facilities where you outsource production or that outsource production to you?
4 - Do you want to minimize the risk of findings, production stoppages, or recalls during audits?
5 - Do you lack a systematic model that identifies and controls risks in advance within your business?

Even if there is a single "Yes" → Audit, compliance, and risk management projects are critical for your business's reliability and audit readiness.