For those in the life sciences industry, audits are a normal and consistent part of their world. Regulatory compliance means all eyes must be focused on product safety and quality. We all take protection for granted, but it is standards such as FDA (21 CFR Part 11), GxP, and ISO 9001 that give business, and the consumer a sense of confidence and security.
So, what about your life science organization? Is the intention there, but your knowledge in need of fine tuning?
Let’s look at a few things those in the industry are doing to ensure compliance.
You may need these to become second nature for your business.
Monitoring should walk happily, hand in hand with auditing. To use a more modern comparison, they should be BFF’s (Best Friends Forever)
Looking carefully at how your business runs, and identifying areas of concern is not about pointing the finger at departments or individuals, but rather a tool to be used for the improvement of all processes and procedures throughout your organization.
Continuous monitoring allows insight to process anomalies that may be overlooked if left until an audit drags you into reality.
Don’t be afraid of the “A” word.
Audits are there to expose all those things that may be happening contrary to your good intention.
In the simplest terms, audits should identify, correct, and improve. Monitoring then acts as a second in command, making sure those improvements are working well.
See? Best friends.
While I’m not saying you should be thrilled with the prospect of the scrutiny an audit can introduce, just see it for what’s its worth. That scary audit monster, when confronted is sometimes just a big misunderstood teddy bear.
Albeit, one with fangs, and wielding a large kitchen knife.
Ok, let’s move on.
A form of monitoring, version control is like having an efficient garbage disposal.
All the editions of documents no longer valid or current are archived, with the most relevant taking center stage. From there, any changes made are immediately recognizable.
A correctly implemented system will ensure documents are all accessed with ease, and more importantly, that everyone is looking at the most current one.
Each version is then approved, for further action and distribution.
I can hear the cheering now.
It is essential that communication remains a priority, and internal practices are examined just as closely as any other protocol.
The last thing any organization wants is for staff to put the company at risk, simply because they are ignorant of the regulatory requirements.
Correct lines of communication allow staff to know, and understand their employer’s efforts in continued compliance. These avenues will empower your people to recognize issues, and bring them to the attention of appropriate people.
Strong corporate integrity, whether disseminating documents electronically, or through verbal communication, should remain the benchmark for all employees.
Taking The Wheel
Regulated organizations are seeing the benefit from the implementation of management software systems , with a view to lessening the possibility of red marks on audit results.
Control focused life science companies tend to sit up and take notice of regulatory needs, simply because they are one of the most vulnerable to issues of non-compliance.
Taking control simply demonstrates to staff, auditors, and competitors that you’re being proactive, that you have an awareness of the intricacies involved in your industry’s compliance, and that you are prepared to tackle issues head on.
Adjust, Improve, Move On
The challenge for any life science business is to continuously move forward. If that is not your organization’s mindset, then you run the risk of being left behind.
Any organization’s success, from a compliance standpoint, and as a potential market leader depends on it.
Whilst most companies are aware of corporate obedience, they do not wish to be reminded repeatedly about the consequences of non-compliance.
For a business owner to avoid the naughty corner, however, adequate time must be dedicated to ensuring you are not on the receiving end of any punishment.
Flaws in compliance management can seriously hurt an organization. Penalties aside, the flow-on effect to customers and their perception of your organization is often tainted, with a path to repair unlikely.
Is it time to look at your controls?