As the FDA increases regulatory enforcement of 21 CFR 11, one of the most difficult things for many companies is to know what their computer systems require to be in compliance. Ofni Systems can quickly assess all of your software, databases, and computer systems and identify what issues need to be addressed for compliance.
At Ofni Systems, 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. Ofni Systems can help you with all phases of auditing and ensure that you get the most reward out of this valuable tool. 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.
A well-managed audit allows you to maximize the value from the audit, as well as projecting control over all of your Quality systems. Ofni Systems uses proprietary software to help manage audits. Ofni Systems can:
Ofni Systems 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.
Increasingly, FDA-regulated companies are being asked to verify the compliance of their suppliers. Ofni Systems 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. Ofni Systems can review your systems and train your personnel to work as suppliers to FDA-regulated companies. Ofni Systems will work to find the best way for your company to meet all regulations applicable to your situation.
If you need your vendors audited, Ofni Systems can provide the expertise to conduct the audits. We can conduct the entire audit independently or include your staff as subject matter experts. We can provide any level of support required, from conducting a single audit to managing your entire audit program.