Are you sure your IT infrastructures are fully qualified, or is it possible that your methodologies missed some vital detail along the way? Perhaps you know you’re good at maintaining infrastructure compliance, but your organization is about to reach its operational limits. Either way, it’s time for a serious change.
Because life sciences firms rely so heavily on distributed computing systems and extensive IT infrastructures, some find it very difficult to maintain compliance without help. Fortunately, you have various options for qualifying your infrastructures and validating the software you use on a daily basis.
It is a common and well-known requirement that the FDA and other regulatory authorities stipulate that the underlying infrastructure on which a pharmaceutical / medical device manufacturer’s business applications are running need to be compliant (qualified) according to the appropriate 21 CFRs and Compliance Policy Guides (CPGs), whenever these applications are concerned with GxP-relevant tasks.
Your ability to keep up with regulations and guidelines so that your products and services remain marketable is dependent on how you choose to approach qualification.
Should Your Firm Qualify Everything?
One common yet misguided approach entails qualifying as much as possible. This strategy has the benefit of practically ensuring compliance, but it can also cripple your organization with massive amounts of work, and all that effort may not even be well spent.
True, it’s usually necessary to qualify every infrastructure component covered by the regulations you want to comply with and whenever the infrastructure components are necessary to support GxP-relevant applications. On the other hand, they’re unlikely to require the same forms of documentation, response strategies or standard operating procedures in case of events like security breaches. Your seemingly brilliant blanket approach could even result in oversights or serious, profit-threatening mistakes.
The Risk-Conscious Strategy
Most large firms and data centers implement platform-specific qualification strategies in order to respond to disparate risk levels. For instance, you’d probably apply more stringent qualification techniques to a server bank that contains personal health information than you’d use for a single computer that only hosts anonymized shipment receipt details.
Component-based IT infrastructure qualification methodologies of this nature are commonly employed to keep GxP and life sciences firms tech compliant without burying them in an unnecessary workload and paperwork.
The advantages of a risk-based methodology include the fact that such strategies are rather flexible. They permit firms to apply techniques that are well-suited to given forms of risk while remaining sufficiently unfettered by constant qualification legwork.
Additionally, life-sciences organizations that operate in multiple markets can more readily adapt their standard operating procedures to relevant regulations without throwing the entire system out of whack.
What’s Right for Your Firm
Now that you recognize the need for balance in qualification, it’s critical that you identify the appropriate level of effort your firm should employ. Before you can actually begin qualifying IT systems and network architectures, you’ll need to learn what really goes into CSV compliance, the qualification of the underlying IT-infrastructures and how these concepts should be applied to the technologies you use.
Life sciences firms that fail to implement organizationally relevant IT infrastructure qualification plans find it very difficult to maintain compliance effectively, especially as they expand their use of technology. Yes, your company is attempting to conform with specific external guidelines, but your methodologies must be tailored to the characteristics of your IT implementations if they’re to bring you into alignment with the rules.
With decades of proven experience, GxP-CC consultants understand how to analyze FDA, Eudralex, ISO and other IT infrastructure regulations so as to help firms adapt to their nuances. Discover more about your ideal IT infrastructure qualification strategy by contacting them today.