Setting up and maintaining an effective quality system is essential in order to ensure that products are safe and effective for their intended use. The Quality System Regulations require you to not only have an understanding of your current compliance by performing frequent audits of your quality system, but also to develop a set of requirements that your supplier’s quality systems must meet.

Reglera employs a full time staff seasoned in performing quality system assessments and audits. Our highly experienced associates, some formerly employed by the FDA, have backgrounds in auditing device manufacturers, cellular tissue organizations, and third parties. The appropriate resource is utilized based on the associate’s experience with your company, product or department to be audited, their proximity to the audit, and their availability. Reglera schedules all audits, travel arrangements, takes care of necessary approvals, reviews corrective action plans, closes open items and helps ensure your audits are timely, thorough and result in the most effective quality system.

The most commonly performed Assessments are:

Gap Assessments

Do you know what areas of your quality and regulatory compliance pose the greatest risk for your organization? Do you know what holes exist that could result in FDA observations? An onsite GAP assessment is often the first service performed with new clients. We provide the necessary staff to come onsite and perform an assessment on all areas covered by the regulation based on your operation. This low cost service provides an executive summary with a prioritized list of areas needing improvement and a more detailed checklist of all observations. We also provide ratings based on the quality and thoroughness of your system and your execution on each system.

Internal Audits

Audits are used as tools to prevent errors, ensure continuous improvement and to enhance the effectiveness of your quality system. Reglera’s auditors can provide an external view of your compliance based on best practices and practical experience. Whether you want to schedule an audit annually or audit individual departments, we will work with you to ensure you have a clear understanding of deficiencies and help you understand how to correct them to improve your overall quality.

Mock FDA Audit

There is no better way to prepare for an FDA inspection than to have an ex-FDA associate provide an on-site role-playing mock inspection. Successful inspections do not happen by chance. Our mock FDA auditors have years of inspection experience and can provide you with an interactive training to ensure you are ready for your next inspection. Feedback is provided as the audit progresses or at the completion of the audit, and weaknesses are identified to ensure they are managed appropriately during an inspection.

Supplier Quality Audit

Whether you are a tissue bank or a medical device company, qualifying and managing your suppliers is not only good business, but a regulatory requirement. Reglera can provide the system and expertise to ensure that the quality systems at your key suppliers are periodically evaluated to ensure that you can count on them to consistently provide a quality product. Reglera team of auditors has tremendous breadth of experience allowing us to match the right resource to your audit. This ensures a timely, comprehensive audit that saves you time and money.