Infrastructure is an important part of any business.

For any company using computer systems within the enterprise IT infrastructure is central to the continuing business operation.

This IT infrastructure would be built up of a series of desktop equipment (PC’s, Printers, etc.), Laptops, Servers and other networked devices, and exists to support the primary business by providing:

•  Platforms to run business applications. (ERP, WMS, VoIP, Quality Management, LIMS, EDMS, etc.)

•  General IT services (eMail, File Storage, Internet access, Office Applications, etc.)

The consequences of the IT Infrastructure not being in effective control can be disastrous. Depending on the nature of the deviation, entire sites or operations in geographic regions can be disrupted until the issue is resolved.

In the Pharmaceutical Industry there is a requirement to validate computer systems that has, or potentially has, GxP implications.  Qualifying the supporting architecture and maintaining its status is vital to the computer systems validation efforts.

The validated status of applications that are supported by the IT infrastructure is compromised if the infrastructure is not maintained in a state of demonstrable control.

IT Infrastructure Qualification is the process of providing documented evidence that the relevant components have been subjected to installation and operational test activities.

Please contact us to arrange you IT infrastructure health check by replying to this eMail, or contact us at our UK Office.

For a Limited period only, we are able to offer free access to cGARD (Our current Regulatory Automated Regulatory Database) that contains all the details on the subject, for 6 months, worth over £300 as part of every IT Infrastructure ‘health check’ we conduct.

Are you ready for Part 11?

The industry has had a number of years to come to terms with the US FDA 21 CFR Part 11. Since 1997, when Part 11 became effective, a number of guidance documents have been published, most recently its 'Part 11 Scope and Application' guidance published in August 2003. It described how the FDA would exercise 'enforcement discretion' with respect to certain Part 11 requirements.

It seems that 'enforcement discretion' as stated in the 2003 guidance is no longer applied. In the last 3 years there have been in excess of 20 Warning Letters related to Part 11 compliance, some with disastrous consequences for inspected companies.

The US FDA now intends to take appropriate enforcement action against companies who fail to comply with Part 11. The FDA will soon begin a human drug inspectional initiative against Part 11 requirements as described in the 2003 guidance. This effort will be part of their effort to evaluate industry's compliance and understanding of Part 11 in light of the enforcement discretion described in the scope of application guidance.

The FDA intends to use the inspectional findings to help assess how to proceed, with regard to the possible modification of Part 11, and fully intends to take appropriate action to enforce Part 11 requirements for issues raised during the inspections.

Companies that have failed to take appropriate action against Part 11, or comply with the spirit of the published guidance, need to ensure that they take whatever action is needed now.

Please contact us to arrange your Part 11 health check by replying to this email or contact us at our UK office.

For a limited period only, we are able to offer free access to cGARD (our current Regulatory Automated Regulatory Database) that contains all the details on the subject, for 6 months, worth over £300 as part of every 21 CFR Part 11 ‘health check’ we conduct.