Availability computing expert calls for greater awareness of the value of hardware uptime in CFR21/11 compliance

Rob Dinsmore

HardwarePT’s availability champion, Rob Dinsmore, has called for the pharmaceutical industry to recognise the value of high availability computing in guaranteeing the security of electronic record keeping in light of CFR21/11.

The US Food and Drug Administration (FDA) CFR21/11 regulation covers traceability and validation in the pharmaceutical supply chain. “Achieving compliance is one thing but leaving machines unprotected, without backup or fault tolerant management capabilities also puts manufacturers at risk,” explained Dinsmore.

CFR21/11 brings significant benefits to pharmaceutical companies by encouraging better electronic record keeping in good manufacturing practice (GMP) and good laboratory practice (GLP) environments. Furthermore, CFR21/11 welcomes, but doesn’t enforce, electronic submissions in new drug applications and updates, promoting the introduction of new technology which can prevent fraudulent changes being made to electronic records.

CFR21/11 is vital for UK manufacturers, because the country is now part of a truly global market which demands product standardisation. Recording information about all transactions involving a drug by using a unique number stamped on to the blister has become compulsory in the US.

Losing the electronic record keeping process could have disastrous consequences for a company attempting to comply with CFR21/11. As a result, HardwarePT’s Dinsmore recommends that all food and pharmaceutical companies, irrespective of the country of origin, ensure that they could comply with CFR21/11 if needed and that their electronic record keeping and submissions are secure.

Stratus fault tolerant computers

In 2007 the FDA lobbied for a law to be passed which states that prescription medicine should use a serialised National Drug Code (NDC) which helps trace the product’s journey from manufacture to dispensing. The records collected are used to verify the authenticity of a product or a number in the supply chain.

“In order for manufacturers to comply with CFR21/11 regulations and provide accurate traceability, all systems need to function at all times,” explained Dinsmore. “The best way to achieve this is through high availability computing systems. Fault tolerance at hardware level means that preventative action can be taken before the problem affects the process. It represents a form of insurance. Fault tolerant servers, which are built by doubling up of all the components, help avoid unplanned downtime.”

For a pharmaceutical company where system failure is not an option, this totally proactive maintenance solution offers security and peace of mind. Furthermore, it gives companies the perfect instrument for manufacturing, packaging and processing lines to comply with the traceability regulations enforced by the FDA.

The use of the kind of fault-tolerant server systems supplied by HardwarePT is ideal for the serialisation process in the pharmaceutical sector, because it offers a shortcut to fixing potential downtime. Skilful use of reliable hardware and software can help avoid costly errors and assist in guaranteeing compliance with FDA regulations.

HardwarePT is the high availability computing and connectivity division of SolutionsPT.