To continue our series on Quality Systems Validation for the Consumer Products industry, I’ve asked Shashank Kadam to address some often overlooked aspects of validation.  As a manager with Clarkston, Shashank leverages his 10 years of experience to help companies improve processes and systems in a regulated environment.

In previous blogs we touched on topics such as “Quality Systems Validation – Does it Apply to Consumer Products?” and “Are You a Consumer Products Company or Drug Company?” As discussed throughout this series, the first question you need to ask is whether or not your organization is in the business of marketing FDA-regulated products.  If so, and for more and more companies the answer is yes, achieving a validated state and maintaining regulatory compliance is just as important as maintaining a strong profit margin.

To accomplish this, there are three key points of emphasis often overlooked when companies consider what is needed for validation.

1. First and foremost, contrary to what many believe, Quality Systems Validation (QSV) is not just a ‘one-and-done’ deal.  It is a journey. To ensure success and compliance, it needs to be an on-going activity with the right people, processes and supporting technologies.  Organizations need to carefully evaluate these requirements and incorporate them into their short and long term business strategies.
2. Second, it is critical to consider who is involved in this journey to ensure success.  From my experience, I have found that the benefits and importance of Quality Systems Validation are often understood at the leadership and strategic levels.  Yet, this understanding often does not exist at the functional levels.  With independent processes mostly sharpened by those involved in the day-to-day tasks, lack of understanding at the functional level detracts from an organization’s ability to adopt these practices.  
3. Finally, companies need to create an organizational culture that understands the importance of validation and compliance.  Clearly defined processes and procedures allow leadership to outline a long-term validation process to support the organization’s ongoing compliance. Companies need to build an organization that is prepared to handle quality-related issues instead of scrambling to respond to emergencies. Focusing on creating a corporate culture to promote QSV and compliance is just as critical as providing the technology and tools.

All in all, if you are an organization that markets FDA-regulated products, it’s your responsibility to ensure proper validation of your quality systems. Given the items discussed above:

• What is your immediate compliance remediation plan?
• What is your long term sustainable model to support QSV?
• How does your organization’s people, process and technology support your QSV practices?

Read the next blog in this series, How to Make Quality Systems Validation Less Daunting.