Consulting & Audit

At it’s core, manufacturing is a simple process; the raw materials or component parts are bought and then turned into a finished product. However, in order to succeed, the manufacturer needs to be able to cover the cost of making the product, meet demand and create a product that is desirable to the market.

Regulatory Compliance

➤ US FDA 21 CFR Part 11 :
We assist in achieving compliance with regulations governing electronic records and electronic signatures to ensure data integrity and security in the pharmaceutical industry.

➤ EU GMP Annexure 11:
Our team helps navigate the European Union’s guidelines for computerized systems, ensuring that your systems meet Good Manufacturing Practice (GMP) requirements.

➤ GAMP5 :
We provide consulting on Good Automated Manufacturing Practice (GAMP) 5, focusing on risk management and lifecycle approaches to validation of automated systems.

➤ MHRA :
Guidance and support to comply with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) standards for the validation of computerized systems.

➤ TGA :
Assistance with the Therapeutic Goods Administration (TGA) regulations in Australia, ensuring compliance with data integrity and validation requirements.

➤ WHO :
Expert advice on World Health Organization (WHO) guidelines for the validation and compliance of systems used in global health contexts.

Audit & Risk Management

Validate your temperature-controlled environments and equipment with our Thermal Validation services. This is vital for ensuring that your equipment maintains the required temperature range during use. Our services include:

Our comprehensive audit and risk management services are designed to identify and mitigate risks, ensuring operational excellence and regulatory compliance. Key services include:

➤ Data Integrity Audits :
We conduct thorough audits to ensure the accuracy, consistency, and security of your data. Our approach includes:

➤ Risk Assessment :
Identifying potential data integrity issues and vulnerabilities.

➤ Compliance Checks :
Ensuring adherence to regulatory standards and internal policies.

➤ Recommendations :
Providing actionable insights to enhance data security and integrity.

➤ System Audits :
Our system audits offer a detailed evaluation of your computerized and enterprise systems, including:

➤ Comprehensive Reviews :
Assessing system functionality, performance, and compliance with regulatory standards.

➤ Gap Analysis :
Identifying discrepancies and areas for improvement.

➤ Documentation and Reporting :
Delivering detailed reports on findings and recommendations for remediation.

➤ Quality Management Systems (QMS) :
We help implement and assess Quality Management Systems to ensure that your processes meet industry standards. Services include:

➤ Implementation Support :
Assisting with the setup and integration of QMS frameworks.

➤ System Assessment :
Evaluating the effectiveness of existing quality management practices.

➤ Continuous Improvement :
Providing guidance on enhancing and maintaining high standards of quality management.

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