We can perform many of the tasks that are part of the Quality Unit responsibilities.
Standard Operating Procedures (SOP)
Most Quality Management Systems are weakened by lack of effective and well-written Standard Operating Procedures. In some cases, even when key SOPs exist, they miss the critical requirements, both from a regulatory and operational effectiveness aspects.
We have successfully helped several clients in establishing well-integrated Standard Operating Procedures that strengthen the Quality Management System, and reduce the cost of quality and compliance. Our SOPS are based on a standardized template and a highly readable and executable form. Our consultants, will do a walk-through of the procedures before developing them, so it will include key inputs from your user group.
An effective CAPA program will reduce your overall rate of discrepancies, and compliance failures. We have helped several clients in developing the overall Corrective and Preventive action program that is geared for reduction of discrepant events, human error, and QMS failures. Our consultants will work with you to establish key Quality Metrics, and integrate it with your Quality Assurance plans. This process is not a magic bullet, and it will take some time to implement, but once it is implemented and monitored, your organization will reap the benefits with reduced cost of Quality and establishment of a sustainable regulatory compliance program.
Quality & Compliance Assessments
Quality Unit is authorized and responsible for a wide-range of activities. FDA typically cites the weakness of a Quality Unit in their 483 and Warning Letters.
We will use your internal SOPS and the most current regulatory standards to conduct assessments of your Quality Management System. We will risk rate your compliance and product quality exposure, and provide you with guidance to remediate the gaps.
Supplier Management Programs often impose a high level of risk and resource burden for many of our clients. We can help by conducting audits and inspection for these key stakeholders of your Quality Management System. Our consultants will conduct a well-defined assessment of your supply-chain’s Quality Management system and provide you with a professional, risk-rated report. We will even help you with developing and implementing strategies for correcting the weakness of this program.
Data Integrity Assessment
Data Integrity is a very hot topic with the FDA, and rightly so. The requirements are so confusing, and the implementation of secure access and a confident Data Integrity prevention plan so complex. We can help. Our consultants, will conduct a thorough baseline assessment of your overall Quality Management System with regards to Data Integrity. We will even help you with developing and implementing strategies for remediating the breaches and addressing gaps that has already been identified.
Batch Record Reviews
One of our Quality Staff augmentation service includes a review of executed batch records, and Laboratory Reports. Our qualified staff thoroughly review your batch records according to a standardized template and criteria based on your own internal SOPS. We will highlight any errors, and its impact on the decision for product disposition.
Quality Metrics Program
An effective Quality Metrics Program is an inexpensive insurance and a key tool for your Senior Management. With the new guidance from the FDA on effect, very few companies have established a robust and effective Quality Metrics program that provides the right, actionable information at the right time.
Our consultants, can help you with reviewing and understanding all the key inputs and outputs for this very important program. We will create visual dashboards so that your entire organization is synced towards the common goals of achieving a robust Quality Management System, and a sustainable regulatory compliance program.