Chromatography Data System - passes security audit

August 2002

Justice Laboratory Software, the leading developer of Chromatography Data systems software, has a long history of providing chromatography software and services to Stafford Miller, UK based consumer health care manufacturers.

For many years the Stafford Miller site in Estover, Plymouth has been using Chrom Perfect® for HPLC and GC analysis of their raw materials and products.  Since the purchase of Stafford Miller by the Glaxo SmithKline group, there has been an increased emphasis on system security, auditing and software validation to meet the conditions of new global directives such as the American FDA CFR21 Part 11, and EU Directive on Electronic Records and Signatures.

During a recent internal audit it was highlighted that the Plymouth plant was not wholly compliant to all security protocols due to the aging IT infrastructure installed in the Chromatography laboratories.  Stafford Miller benefits from the services provided under Justice Laboratory Software’s extended support agreement, and contacted their European Support offices for guidance and advise on how best to address these regulatory issues.

After an initial consultation with the Analytical Department Manager, John Clements,  System Administrator, Rob Wing and IT Manager Dermott Tackaberry, a proposal was agreed with the following action points:-

• Upgrade the operating system environment in the lab, thus making use of advanced security features to ensure that data could not be accessed at a system level by unauthorized staff.

• Upgrade to the current version of Chrom Perfect® Spirit (V5.3) to ensure that data is digitally signed and fully audited via the latest System Manager utility which allows multiple access privileges and user/group administration.

• Upgrade to the latest Chrom Perfect® Tigre IV chromatography interface devices. To provide a secure and reliable platform, allowing simultaneous data acquisition from multiple chromatography instruments.

The above actions were carried out in August 2002.

“We have been using Chrom Perfect® for a number of years and are pleased with both the product and the support service that we receive from the JLS offices in the UK.  As we support a production facility, our application is fairly demanding and we require the system to run around the clock, which is one of the reasons we originally decided to use Chrom Perfect®.

Due to the requirements of our parent company, GSK, addressing potential security issues in the operating system and the requirement for a password and auditing system within Chrom Perfect® was a major priority for the lab this year. After discussions internally and with Justice Laboratory Software, the project was completed very quickly with little or no disruption to our laboratory.  The combination of new Chrom Perfect® Spirit software/hardware and improved computing systems has made a big difference to the laboratory from an operational point of view. 

From the security view point we now have a Chrom Perfect® system which is fully audited with password protections and various levels of user and administration privileges and access. This coupled with the new IT environment has addressed the various points which were highlighted at our last audit."

- John Clements, Analytical Division Manager 

“The project at Stafford Miller highlights the global dynamics that affects many of our customers.  With the introduction of new directives such as 21 CFR Part 11, we have enhanced the security and auditing features within the Chrom Perfect® range. While maintaining the ease of use and powerful data processing facilities our customers expect.

With the next revision of Chrom Perfect® available soon, even more tools will be available to users to  meet ever increasing corporate and regulatory demands, while at the same time providing a powerful set of tools for their main job, which is of course, acquiring and processing Chromatography data.

- George Schriener, Vice President of Technical Development Justice Laboratory Software, Denville, NJ, USA