Press Release

cGARD brings regulations to your fingertips - 25/01/06

Regulatory queries and questions could be wiped away by a comprehensive new directory of compliance regulations. cGARD has been launched by Compliance Control Ltd., and brings together precise and accessible information that can be used to assist companies in co-ordinating their corporate regulatory information. (cGARD – current Global Automated Regulatory Database)

The Compliance Control Ltd. team that has compiled the directory has more than three decades of collective experience and have combined this with input from major organisations and industry bodies.

The launch follows several pilot projects in which the system was successfully used by a number of leading biopharm companies.

David Forrest, Chief Executive of Compliance Control Ltd. believes the new directory will be important to both multi-national organisations and smaller companies. “In addition it could also be particularly useful for companies in lesser known markets – such as those in countries new to the European Union and even those in the sub-continent looking to manufacture and compete in global markets,” he said.

The product is available on CD and can be installed on a laptop or desktop, or on an internal network, so anyone using it will have access to the latest rules and regulations at their fingertips. It is simple to access and exceptionally user-friendly. On-line access to regular updates will be available for registered users.

cGARD offers easy access to current global regulations, delivers flexible searching and reporting capabilities and enables rapid keyword searches based on industry-defined compliance subject areas.

“As no single global repository of current regulations with regulations categorised exists, cGARD stands alone as regulatory tool for executive managers, project managers, quality assurance professionals in addition to compliance and validation staff,” added Mr Forrest.

“With the opportunity to use cGARD for staff training, updates and self-help activities, it has already proven that it can be extremely helpful to employees in understanding the importance of achieving compliance and to instinctively do things the right way.”

Validation and Compliance minefield – a problem of the past? - 09/01/06

A brand new resource which for the first time offers a comprehensive overview of Validation and Compliance data has been launched for the pharmaceutical and life science industries.

ComplianceControl Centre is a unique new Oracle-based software suite that can integrate with any proprietary off-the-shelf or in-house developed systems to provide senior executive and management with real-time control and visibility of the complete Validation and Compliance status of their organisation.

The software has been developed primarily for the life science and pharmaceutical global markets, where compliance and validation in manufacturing, research and development, clinical trials, supply and support systems such as IT are pivotal to the success of a new drug.

The system stores all critical Compliance data in a secure single database which is available and visible - with scalable levels of access - across an organisation. It tracks the status of projects, documents, systems, software, hardware, manufacturing and laboratory equipment. In addition, all project risks, changes, minutes, issues and actions are visible in real-time as is an overall assessment of compliance.

The launch of the ComplianceControl Centre follows a period of extensive research by parent company Compliance Control, which is headed up by David Forrest, an IT and compliance specialist with more than 21 years experience in the pharmaceutical industry.

“Projects undertaken in both existing and emerging markets have provided a very clear indication that controlling Compliance is not only a critical issue but also one where there is a real need for specialist systems and software,” he explained.

“We believe there is a need for such a system in most organisations. Small and medium organisations, for example, cannot afford the various corporate systems available. Very often spreadsheets or ad hoc in-house databases are created and used to ensure Compliance, but these are time consuming and inefficient to maintain and support. The availability of software like this gives them a corporate system at a fraction of the cost and one which can remain as they grow and develop, without demanding regular upgrades and development.

“In the case of larger organisations, many already have policies and procedures in place for Compliance and Validation and many work very well indeed. However, even here, there are often many variations in the systems used and indeed how those systems are used. There’s no doubt that a single central repository for Compliance data would save many large organisations a lot of time and money and allow them real time access to current Key Compliance Indicators. That’s what we believe we have brought to the market.”

Editor’s Notes:

David Forrest BSc (Hons) CEng MBCS CITP

David Forrest has been involved in the IT industry for more than 25 years. The vast majority of that time (21 years) has been spent in the pharmaceutical sector. Mr Forrest was one of the initial founders of FJ systems, a systems integration company, which was instrumental in the creation and initial editors of the early versions of the GAMP®(Good Automated Manufacturing Practice) guide.

He has worked on projects for both large and small life science organisations throughout Europe and the USA. Mr Forrest, also a qualified TickIT auditor, has undertaken more than 50 audits and has been involved in countless IT and Compliance projects.