For some pharmaceutical enterprises, the thought of an FDA audit inspires fear. The mad dash for generating reports, organizing documents, and ensuring all compliance bases are covered can be one of the most stressful experiences in the pharma lifecycle. However, with far-sighted preparation and the right tools, biotech and life science companies can view FDA audits as another routine function in the pharma lifecycle.
Let’s talk about how taking a proactive approach to compliance can help pharma companies plan ahead for smoother FDA audits. We’ll also highlight the compliance-enhancing opportunities pharma companies can gain by leveraging technology like VDRs for FDA audits. If that sounds like too many acronyms, don’t worry. We’re here to decipher the lingo and help take at least some of the stress out of the audit process.
Understandably, the pharmaceutical industry is highly regulated. When it comes to prescription drugs, lives are at stake, making compliance especially critical. Despite the administrative headache, audits can be viewed as a positive safeguard protecting consumers.
“FDA works to ensure the medications that are available to hospitals, health systems and patients are safe, effective and of high quality,” says the U.S. Food and Drug Administration (FDA). “It is the industry’s responsibility to comply with the law regarding drug safety and quality.”
Biotech companies that take their compliance obligations seriously are more likely to ensure long-term success in the industry, protecting their reputation along with their bottom line.
Organizations operating in the pharma space should anticipate and prepare for audits at several points throughout the drug creation and manufacturing lifecycle.
Types of FDA pharma audits include:
- Pre-Approval Inspections – The FDA audits a company’s manufacturing facilities to ensure operational and production safety.
- Application-Based Inspections – “Application-based inspections are conducted for about 20% of the application reviews conducted by the agency,” says the FDA.
- For-Cause Inspections – The FDA audits pharma operations that have reported or suspected compliance problems.
- Surveillance Inspections – The FDA monitors the drug manufacturing process to ensure quality.
- Routine Inspections – The FDA makes periodic audits to review ongoing pharma compliance.
- Follow-Up Inspections – The FDA performs follow-up audits to review remedial actions taken after a previous audit or compliance violation.
- Data Integrity Audits – The FDA audits pharma data trails and sources to verify accuracy and data integrity.
- Supply Chain Security Audits – The FDA checks the security and safety of various parts of a pharma’s supply chain.
- Risk-Based Audits – The FDA may perform more vigorous or frequent audits on higher-risk operations.
What can life science organizations do to prepare for mandatory FDA audits?
FDA Audit-Ready Checklist for Pharma Companies
Companies in the biotech industry must expect audits and operate accordingly. Good preparation and follow-through on compliance procedures protect pharmaceutical companies from the risks of non-compliance.
“Your goal should be that an FDA investigator could walk in any day, with no notice, and find an inspection-ready operation,” advises The FDA Group, a talent-sourcing resource for the pharma industry. “This isn’t about being perfect; it’s about having systems that make quality the default state rather than a special effort.”
Of course, no two pharmaceutical companies are exactly alike, so a custom approach to compliance is necessary in each case to address all applicable regulations. However, biotech organizations can use the following checklist to analyze their audit readiness and enhance their approach to FDA compliance.
Here are five steps to preparing for an FDA audit:
1. Implement a Rigorous Compliance Program
Pharma executives should work together to create and roll out a comprehensive compliance program across departments. The program should establish clear policies and procedures for ensuring regulatory compliance, assign responsibility for implementing these measures, and be regularly reviewed and updated. Companies should provide obligatory ongoing employee compliance training.
2. Conduct Regular Internal Quality Checks
A company that self-monitors for quality and compliance and adheres to high standards effectively mitigates many non-compliance risks. Biotech companies should build mandatory periodic compliance reviews into each phase of the product lifecycle.
3. Anticipate Failures and Create a Response Strategy
Since any operations are subject to the risk of human error and other failures, it’s important to plan ahead for oversights and mistakes. Establish clear protocols for how to handle errors, promoting transparency and data integrity.
4. Maintain Detailed, Secure Records
Keep rigorous documentation at every step. Pharma data must be detailed, organized, accurate, and complete. A third party, such as an auditor, should be able to navigate the documentation intuitively without the need for excessive back-and-forth communication for clarifications. Beyond that, the data must be securely stored for maximum security and compliance.
5. Invest in Compliance-Enhancing Tools
Long before facing an audit, pharma companies can onboard compliance-boosting tech tools to help organize their organization, securely store data, and promote efficiency. Investing in such tools demonstrates a commitment to compliance and can help inevitable audits go more smoothly.
Speaking of leveraging technology for enhanced compliance, this brings us back to VDRs for FDA audits. What is the role of VDR technology in prepping for and facilitating FDA audits?
How Can Virtual Data Rooms De-Stress FDA Audits?
Virtual data rooms (VDRs) are becoming the new gold standard for pharma data management. A VDR can offer biotech and life science organizations a centralized platform for efficiently accomplishing several compliance objectives.
VDRs for FDA audits can help pharma companies to…
- Ensure secure data storage with military-grade encryption
- Collaborate across departments for audit-readiness
- Maintain an auditable data trail via detailed document activity tracking tools
- Generate custom reports for decreased administrative burden
- Communicate with the authorities through a secure, professional portal
- Demonstrate due diligence
Of course, we’d be remiss not to introduce your company to our game-changing VDR for FDA audits.
Enterprise-Level VDR for FDA Audits
CapLinked offers pharmaceutical companies an end-to-end solution for hitting all of the above targets. Our VDR software is designed to de-stress audits, mitigating risk while maximizing security. This next-level VDR software equips biotech organizations with the tools they need to ace their next audit by preemptively organizing their data on a secured platform.
Reach out for a customized VDR solution for your organization.
