At LCT, we recognize that an FDA audit can be quite unsettling. However, we like to think of an audit as another opportunity to add value to our clients' business. Auditing allows companies to review their internal and external compliance issues in an open and honest manner. LCT can help you with all phases of auditing and ensure that you get the most reward out of this valuable tool. LCT can provide a full review of a facility, product line, or system to determine its compliance with applicable regulations.  Our recommendations draw from both FDA and European regulations and guidelines to assure your firm will be compliant on a global scale. Our auditors have worked with large and small companies, in all aspects of FDA regulated fields from clinical trials to medical devices to biological products to medical imaging to generics.

The report we issue following an audit is much more than a check list of findings. Each item is prioritized, so you will know where to put your efforts first as well as the risk the item poses. Each item is explained in detail, including what was found, why it is not in compliance, and with possible examples of ways the situation can be corrected.  A full list of references is included for further research. Our reports stand above the rest! 

Be Prepared for Compliance Audits

• Audit Checklists – LCT can develop tools to facilitate your system review and ensure that your systems meet all applicable regulations.
• Gap Analysis - Before an FDA inspection or regulatory compliance audit, LCT can review your internal and external quality systems against established industry and regulatory standards and assess if your company's actual practices meet those standards.
• Remediation Plans - If gap analysis identifies gaps, we can create a remediation plan to address the findings.
• Compliance Training – LCT can also help training your employees to be proactive in dealing with compliance issues.

Audit Responses and Corrective Actions
LCT can recommend the appropriate responses to audit observations. We can help you determine the appropriate corrective actions and help your company implement changes to your quality systems.

Supplier Audits

Increasingly, FDA-regulated companies are being asked to verify the compliance of their suppliers. LCT can assist you with all phases of supplier compliance audits.

If you supply FDA-regulated businesses, we can assess your systems and help you prepare for an audit. We can review your systems and train your personnel to work for regulated companies. Lifecycle Technologies will work to find the best way for your company to meet all regulations applicable to your situation.

If you need your supplier’s audited, LCT can provide the expertise to conduct the audits. We can conduct the entire program independently. We can provide any level of support required, from conducting a single audit to managing your entire audit program.

Benefits of Using Lifecycle Technologies for GxP Audits

• Experience with FDA and GxP requirements. Lifecycle Technologies provides services to companies subject to FDA regulations and are experienced with issues relating to compliance. We can efficiently review your Quality and regulatory systems and determine if they meet all of your business and regulatory requirements.


• Improved Value to Your Quality Systems – Auditing increases the value of your systems and improves the software development process.

LCT can assess organizations' compliance with:

• GMP (good manufacturing practice) for intermediates, active pharmaceutical ingredients (APIs), and finished drug products
• QSR (medical device "GMP")
• GCP (good clinical practice)
• GLP (good laboratory practice)

We also have extensive experience in:

• Performing "mock" FDA pre-approval inspections helping to ensure that problem areas are identified and addressed before the real inspection
• Developing drug diversion prevention and counterfeit investigation programs
• Helping organizations ensure compliance with the Prescription Drug Marketing Act (PDMA)
• Auditing adverse drug event (ADE) programs from collection and evaluation through reporting and follow-up
• Qualifying vendors
• Performing due diligence
• Conducting regulatory audits
• Auditing documentation, including application integrity audits
• Verifying activities of the regulatory committee