“Discover the most common compliance mistakes made by life sciences companies and learn how to navigate regulatory challenges to protect your business and ensure safety.”
Read on, as we take you through the regulatory landmines lying in wait for unsuspecting developers.
Introduction
Life sciences is an innovation in the service of human health. However, it is also an industry which requires adherence to stringent regulations.
Not complying with these regulations can lead to not only monetary losses but also create public safety hazards and ruin a company’s image.
We will also be discussing certain common compliance missteps of life science companies and how to avoid committing these FDA violations while navigating within the regulatory landscape.
Neglecting Regulatory Updates
Not keeping current on regulatory changes: One of the biggest mistakes made in life sciences is not staying abreast to what regulations are changing. For example, FDA regulations are revised and modified constantly.
This results in not being able to comply with changes. At BioBoston, our team of seasoned professionals has been actively monitoring regulatory changes to help ensure that your organization operates according to the most current compliance protocols.
Inadequate Documentation
In the life sciences industry, documentation is key to compliance. If your documentation is incomplete or contains an error, it can lead to FDA violations and major delays.
Consultants stress that keeping good records is crucial for proving compliance. This goes a long way in compliance besides enabling companies to respond effectively during audits and inspections.
Inadequate Quality Management Systems:
To ensure compliance, an efficient Quality Management System (QMS) is crucial. Life sciences companies with the architecture of a poor QMS, or those that have not operationalised and effectively deployed their existing one are at risk.
We are a consulting firm that focuses on designing and perfecting compatible QMS with regulatory standards for lower non-compliance risk.
Insufficient Training
It takes a well-trained workforce to support those systems and processes. Insufficient training of employees leads tomistakes and non-compliance.
Customized training programs for your organization based on best practices that clarify regulatory obligations and prepare staff to navigate them.
Data Integrity is not Included
For life sciences companies, especially when it comes to research or clinical trials and manufacturing, data integrity is critical. Defrauding the data or turning a blind eye to the data integrity issues can have consequences that could lead to FDA violation notices or warning letters.
Our consultants can assist you with implementing data integrity solutions that protect the reputation and compliance of your organization.
Ignoring Risk Management
Compliance = Risk Management: Traditionally, life science companies underestimate the importance of identifying and mitigating risks associated with their products and operations.
We focus on risk assessment and management approaches to determine not only how compliant are you, but also how quickly can we get back to business.
Inadequate Supplier Oversight
The life sciences industry has embraced outsourcing, but failing to perform adequate vendor oversight can prove very expensive.
Supplier Management Risks: Poorly managed suppliers can create quality and compliance vulnerabilities. We offer support for effective supplier management procedures that ensure compliance across the supply chain.
Conclusion
For the life sciences industry, compliance is a must in its complex landscape. Common errors in compliance can result in a variety of consequences: from FDA violations to potential loss of reputation.
With the life science sector continuing to evolve, BioBoston Consulting knows these twists and turns inside out and helps your biotech or pharmaceutical company maintain compliance while positioning you for growth. Compliance pitfalls are not natural parts to growing your company. Allow us to help you through regulatory landscape successfully.
Could your organization benefit from our services? Contact us at BioBoston Consulting today .
