Stafford Miller Upgrade to Chrom Perfect Version 5 and Tigre IV interface for enhanced data security, validation and auditing
Justice Laboratory Software, the developer of chromatography data systems software for the science-based industries, has a long history of providing chromatography software and services to consumer health care manufacturer Stafford Miller.
For many years the Stafford Miller site in Estover, Plymouth has been using Chrom Perfect for HPLC and GC analysis of its 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 its European support offices for guidance and advise on how best to address these regulatory issues.
After an initial consultation with analytical department manager John Clements, system administrator Rob Wing, and IT manager Dermott Tackaberry, a proposal was agreed with the following actions were taken: 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 unauthorised 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.
John Clements, analytical division manager, said: "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." George Schriener, vice president of technical development at Justice Laboratory Software, said: "The project at Stafford Miller highlights the global dynamics that affects many of our customers. "With the introduction of new directives such as CFR21 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.
