Compliance Specialists, L.L.C. provides a wide variety of consulting services to pharmaceutical and medical device companies. CSLLC has experience developing/improving/implementing quality systems that are comprehensive, yet practical, and tailored to the resources available. If your company is not based in the United States, CSLLC can act on your behalf as your “US Agent” (pharmaceutical manufacturers) or as your ”Official Correspondent” (medical devices).
I’ve been asked many times by potential clients “Why do I need a consultant?”. I always respond with the same question...how are your quality systems working for you? I would ask the same thing of the visitors to my Website. How are your quality systems working for you?
Are the same deviations showing up time after time in your corrective action data base?
If so, your CAPA system isn’t correcting them so they don’t recur. This is a requirement of the regulations and an important aspect for the constant improvement of your quality system.
Do you have deviation investigations that have been open over 45 days?
Investigations should be completed in 4 - 5 weeks.
Do you have CAPAs that have been open over 30 days? 60 days? 6 months?
If so, the CAPA system isn’t working properly. CAPAs should be closed within 30 days unless you’re waiting on an Engineering evaluation or arrival of new equipment needed to resolve the CAPA. The CAPA system is the way you improve your quality system. If you’re letting CAPAs sit around open for a long period of time, you’re missing opportunities to improve the level of compliance at your facility.
Do most of your CAPAs give “employee training” as the corrective action?
Many companies take the easy way out and list employee training as the cause of deviations. Most employees want to do a good job and will labor under an inefficient, unclear, or poorly written process without too much complaint. Then, when there is a deviation, supervisors are quick to blame the employee. In my experience, deviations are caused by process related issues more than 90% of the time. It does no good to retrain employees if the process they’re using is faulty.
Do you have audit findings from a recent audit that have been open more than 30 days?
Note that many of the above questions target a company’s response to deviations and irregular occurrences. The way to evaluate your quality system is how it performs when bad things happen. It’s easy to think you have an efficient quality system when things are running smooth. But the real measure of a quality system is how it performs when there are problems.
CSLLC can provide assistance in the following compliance areas for both pharmaceutical and medical device companies:
- Development of Compliance Improvement Strategies
If you’re not doing long term compliance planning when you develop other company growth strategies, you’re missing a key element that could derail all your other plans.
- Perform Mock FDA Audits
Prepare your firm for FDA inspections by conducting “FDA-like mock inspections”.
- Conduct document review of company policies, procedures, work instructions, and data collection forms with subsequent recommendations for improvement. If your SOPs are over 5 years old, most probably non-value-added steps have been inserted. These steps are costing you efficiency, money, and morale as employees follow procedures that they know could be better. CSLLC can support or improve your quality system by reviewing your key SOPs and making recommendations to improve SOPs and make them more effective and efficient.
- Perform internal GMP, QSR, QSIT, or “gap” audits to identify potential problem areas prior to an FDA inspection. CSLLC provides comprehensive Quality System audits that help you reduce regulatory risks and avoid unexpected expenses that can result from FDA audits. Furthermore, a CSDLLC audit improves and strengthens internal audit programs by interpreting FDA regulations, policy, and guidance documents related to cGMPs and QSR. Detailed audit reports are provided defining the significance of the findings from an FDA viewpoint. Reports include the possible course(s) of Agency action and each finding is referenced to current regulations.
- Auditing of suppliers or contract manufacturers
- Performing employee training on the GMPs or the QSR
- Preparation for, and management of, an FDA Inspection
Including training for key employees in how to manage an inspection and how to interact effectively and expeditiously with FDA in response to FDA 483’s and warning letters. - Assisting companies in reducing a backlog of open investigations, CAPAs, failure investigations, or deviation reports
- Work extensively with Executive Level and Senior Management to develop sound quality assurance and regulatory strategies to address compliance issues CSLLC will participate in management review meetings to ensure these processes meet regulatory requirements and that they work to reduce overall costs, minimize regulatory risk, and meet business needs.