ComplianceControl launch new software

The ComplianceControl Centre, is a new and unique software package, which can be integrated with existing in-house systems to help pharma manufacturers adhere to validation and compliance issues.

It stores all critical compliance data in a secure database, which is available across the company. It tracks the status of projects, documents, systems, software, hardware and 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 system will knock days, weeks, even months off projects due to visibility of compliance information,"​ David Forrest, IT and compliance specialist and head of >ComplianceControl,​ told www.In-PharmaTechnologist.com.​

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.

"There is a need for such a system in drug manufacturing companies but most small and medium organisations cannot afford the various corporate systems available,"​ said Forrest.

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, he explained.

"The availability of software like this gives manufacturers 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,"​ said Forrest.

We estimate that customers can save between 10 and 20 per cent on compliance expenditure per year by using our software package, said Forrest.

Its estimated cost will be between £1000-2000 per user and Forrest believes that customers that invest in this technology will reap their initial outlay back in cost savings within the first year.

In addition to small to medium UK companies who currently used manual compliance processes and now want to move their business forward, Forrest anticipates that its initial client base will also come from large pharma companies that want to streamline their existing in-house compliance programs.

"In the case of larger organisations, many already have policies and procedures in place for compliance and validation, however, there are often many variations in the systems used and how they are used and 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,"​ he said.

Furthermore, Forrest believes the software will be popular among medium to large eastern European companies who are new to the European Union, as it will help these drug manufacturers to meet strict EU regulations in weeks rather than years.

"These countries do not want to go through the same expensive 10-15 year learning curve which some of the major companies in Central Europe and the USA have,"​ explained Forrest.

"They are looking for a quick and effective route to compliance and beyond that, ways to ensure they will remain compliant in the future,"​ he added.

The company will launch the ComplianceControl Centre in UK/EU later this month and hopes to roll it out worldwide 3-6 months later.

To complement the ComplianceControl Centre, the firm has also just launched the cGARD v3.0, a database program that contains details of the regulatory requirements of different countries around the world. Using this information, manufacturers can check that they are in compliance with their domestic manufacturing requirements, along with the requirements of any country that they may wish to export to.

No other single global database of current regulations with regulations categorised currently exists and cGARD can be downloaded from the Internet for £699 per user.

The company anticipates an uptake of thousands of users of this database in the next few years.