FDA Quality Systems Records Integrity

More than 90% of all FDA regulatory enforcement hinges on 1 point:  the integrity—or lack thereof—of your records.  What are the steps to prepare for an inspection of records and document integrity?

 With my clients, I use a practical approach reliant on four themes:

1.       Clarity of accountabilities

2.       Clarity of expectations

3.       Simplicity of risk control

4.       Transparency of knowledge

 

Clarity of Accountabilities

As a company leader, you are in charge of setting out the accountabilities of each department within your firm.  Set down these accountabilities in writing.  This does not need to be detailed job descriptions, but rather, brief statements on who is accountable for what aspects of capturing, maintaining and archiving information.

At a minimum, you will want to identify the roles of your information technology (IT/ICT) group, your regulatory affairs and quality teams, your records management and archival group, and your legal department.

As simple as this sounds, I’ve repeatedly found that companies struggle with this aspect of record integrity.  As you develop your document and data handling procedures and policies, continue to check-in with your teams to ensure mutual agreement on accountabilities and expectations.

When the inspection or the lawsuit is announced, it's too late to figure out who should have been acountable.

 

Clarity of Expectations

Hand in hand with an understanding of accountability, you—with your teams—need to lay out expectations for your company’s level of confidence when it comes to data quality.  Consider adopting, at minimum, the same standards of confidence you expect from your product, whether that’s 95% accuracy and reliability, 98% accuracy and reliability, etc.

Do not make this any more complicated than it needs to be.  If nothing else, this confidence level can be your starting point, leaving room for continuous improvement.

 

Simplicity of Risk Control

The challenge here is not to “dumb down” your firm’s risk management methods, but rather to identify those elements applicable to each group’s set of information accountabilities.  Each of your teams (and their individual members) should know enough to recognize a potential risk when an unknown unknown (or “unk-unks” as they are called in product development) arises.  At that point, your documented risk management and control policies kick in.

 

Transparency of Knowledge

Finally, you will still be left with two challenges:

1.       Ensuring you have data and accountability transparency; and

2.       Ensuring each of member of your company has the know-how to recognize and tackle new situations as your business evolves.

Data and accountability transparency can be addressed by combining the concepts of flowcharts and organizational charts.  For instance, take your organizational chart and trace the proof of patient safety and product efficacy through various levels of management and personnel.  This defines who is accountable.  Next, make a flowchart of where the data sits on various systems in use throughout your company (or in outsourced providers).  This is where the data is located.  Then, correlate the two charts to draw relationship lines between them.  This will allow you – and your team – to identify, at any time in the information’s life, who in your organization is accountable.

Ensuring your teams have the know-how to recognize and tackle new situations as your business and marketplace evolve is a long-term commitment inherent in information’s long lifespan.  Tactics to handle this will depend upon each group’s accountability, but several principles apply.  Training may be an obvious one, but so is continued awareness of industry trends and best practices.

If you are running lean and cannot devote the time constantly assessing industry trends and best practices, consider asking a third-party for a summary document of items that might be applicable to your company and the information you guard.  I recently put together a report and set of recommendations for a client who was trying to improve their inventory control and the management of their supply chain.

 

Final Thoughts

For companies whose entry of new products into the regulated marketplace hinges upon a review of information proving product safety and efficacy, record integrity is the quiet elephant lurking in the corner.

Have you put in place an FDA records management program yet?  Does it support the record integrity and data quality of your submissions?  Can it withstand a pre-approval inspection?  Know the answers before the inspector shows up.

Are you ready?