The new services includes software quality assurance audits, IT service provider and application vendor audits, infrastructure audits, with the highlight of the new services being a complete audit management service of good manufacturing practice (GMP), good laboratory practice (GLP) and good clinical practice (GCP) requirements, the firm said.
Kathleen Pelley, director of the Quality and Compliance Group at Court Square, spoke with Outsourcing-Pharma.com at the show and explained that there are three levels of auditing that companies may seek.
The lowest level is a reactionary, crisis level mode, where a company has already run into difficulty in regard to their IT and/or business processes, for example with a regulatory inspection, and do not have the internal capabilities to react to it themselves and so they require outside assistance.
The second level is when a company is not in crisis mode, but wanting to undertake a proactive self evaluation to ensure that their processes and the quality of their product is regulatory compliant.
The highest level of audit that companies can seek is when they request an inspection of the processes and systems of any potential vendors prior to entering into any contracts or agreements, in order to determine whether the vendor meets both its business and its compliance needs.
" All three audit levels require a full-time in-house audit team, although this is very expensive and the workload of the audit team can vary greatly and companies don't want to have to incur this expense ," said Pelley. "
However, with the programme that Court Square has put together, we can now go in to companies and offer to manage these audit services for them… Most clients find that sound auditing services pay for themselves in a very short period of time. "
Pelley said that the service covers the core spectrum of pharma processes, GMP, GCP, GLP, as they all have IT-related components, and the firm can also arrangem for the management of audits of manufacturing, production, cleaning and validation processes, in addition to more traditional IT audits looking at data centres, networking and infrastructure.
Moreover, Pelley said that the firm is experiencing an increased demand from clients for the auditing of potential software vendors.
" Many mid size and large companies are outsourcing IT services and this is bringing up a whole new area of auditing. "
" If you are outsourcing such a key component of your business, as IT is, you want to be sure that all of the processes and systems in place in your vendor are up to scratch ," she said.
Pelley added that many life sciences companies simply don't know which systems are likely to be inspected by the US Food and Drug Administration (FDA), or how deeply.
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In fact, all IT systems should be audited, but risk-based analysis helps you determine which ones need the most attention.
Many companies waste time and money because they fail to understand this process.
Our highly-trained auditors know which systems need more attention than others ," she said.
In line with a growing market demand, Court Square is planning to employ more staff over the next few months and within the next two years it envisions opening offices in Philadelphia and New York, in addition to a new location on the US West Coast.
Meanwhile, company CEO Keith Parent told Outsourcing-Pharma.com that his firm also wants to change the way companies use IT, steering them towards using it as a business tool, rather than simply viewing it as a cost. "
The industry's mindset towards IT needs to change, so that they are not always in reactionary mode, but being proactive and maturing to the next level ," said Parent.
" There is so much life sciences firms can use IT for in their business model, and we want to help companies build this in to their business from the start.
Doing so will be better for the business and save money for the company in the long run. "