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Articles

A Practical Approach to Enterprise Risk Management

By: 
Ian Lucas, Director, SeerPharma, Melbourne
Published : 
March, 2013
Enterprise Risk Management, System

An integrated, well designed Enterprise Risk Management system allows companies to make agile decisions based on real life data to tailor expenditure and minimise overall company exposure.

This paper describes a method for developing an Enterprise Risk Management repository & uses actual events/incidents to review the effectiveness of defined controls to measure overall effort & costs.

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Risk Management for LIMS Projects

By: 
John Boother, Managing Director of Autoscribe Limited and President of Autoscribe Informatics Inc.
Published : 
October, 2012
LIMS Risk Management

There are many Laboratory Information Management System (LIMS) projects that have collapsed or failed to deliver the expected benefits. In addition many projects are significantly over budget with non-budgeted on-going costs e.g. IT consultants on site for many months after delivery of a system.

 

Furthermore projects of this nature end up with a changed specification from that originally described.

This paper lists some of the risks and introduces the Autoscribe approach and initiative aimed at reducing these risks.

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Identifying and Mitigating the Challenges of Upgrading to a PIC/S GMP Environment

By: 
Darren Freestone, Senior Consultant, SeerPharma, Singapore
Published : 
February, 2012
PIC/S, GMP, Upgrade, White Paper,

The paradigms are changing, the focus is shifting and changes are inevitable.

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ICH Q10 Pharmaceutical Quality System

By: 
Ian Lucas, Director, SeerPharma, Melbourne
Published : 
April, 2012

ICH Q10 is a comprehensive model for a pharmaceutical quality system that can be implemented throughout different stages of a product lifecycle. The aim is to establish and maintain a state of quality control and to facilitate continual improvement. Implementing well defined, integrated processes that work within the culture of the organisation is paramount. Implementing an automated solution can greatly increase the chances of success.

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Automating compliance with ICH Q8

By: 
Ian Lucas, Director, SeerPharma, Melbourne
Published : 
May, 2011

ICH Q8(R2) provides a quality risk-based framework for Pharmaceutical Development companies to implement in order to design a quality product and consistently manufacture to the intended performance of the product.
The outcome is enhanced knowledge on the product and the process.
As much data is collected, analysed and disseminated, an automated system that records and controls the development process greatly enhances the chances of successful compliance.

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Application of Risk Management to New Medical Devices

By: 
David Grennan, Senior Consultant, Ray Collyer, Senior Consultant, SeerPharma (Singapore) Pte Ltd
Published : 
April, 2012

When introducing a new Medical Device onto the market, a number of well-defined risk analysis and evaluation phases should be undertaken. Risk Management and the performance of Risk Assessment are crucial parts of the design, development and control process.

Risk Assessment is a valuable tool and a regulatory expectation that should be used throughout the whole of the product life cycle to ensure a safe and effective product.

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Computer Validation

By: 
Ian Lucas, Director, SeerPharma, Melbourne
Published : 
April, 2012

There is no silver bullet to ensure that your validation projects will be successful, but using a structured methodology and a science based risk assessment process, the chances of determining the correct ordering of activities will be greatly enhanced.

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