subject: What You Need To Know About 483 And Quality Control [print this page] As we all know, an FDA 483 or a 483-warning letter is issued to a company for not complying with the FDA quality system standards:
Not having procedures in a regulated area that conform to FDA compliance;
Having procedures that conform to FDA compliance, but not following them; or
Having procedures that comply with FDA regulations and following them, but not having adequate documentation to show that you are following them.
In a computer-based quality system environment there may be several factors that might contribute to issuing 483 warning letters.
FDA quality system requires sufficient data security with ability to overwrite data. FDA compliance rules make it mandatory for a company to be able to achieve this objective or work towards implementing it.
Computer validation at the vendor's site is not enough. Computer software verification and maintenance of records concurrently are essential to FDA compliance rules.
Legacy computer systems need to be validated by FDA regulated consulting services. Integrated computer systems that are not configured will lead to an issuance of FDA 483.
FDA regulatory consulting services make it mandatory on the software companies to validate off-the-shelf software such as Microsoft word and Microsoft excel. Failure to validate that leads to violation of FDA compliance standards.
Adequate storage and back up is absolutely necessary to abide by FDA compliance procedures. Complying with this rule will not only ensure a quality system validation but will also lead to reduced FDA compliance costs in the long run.
An FDA 483 will be issued if accuracy of inputs to and outputs from HPLC instruments are not checked. FDA regulatory consulting services will ensure that these issues are addressed and compliance to these standards in the future will definitely reduce FDA compliance costs.
FDA compliance costs can be significantly reduced by saving electronic raw data, validating databases for data analysis and other tracking and trending functions.
A 483-warning letter will be in place if it is found that electronic data in a company has been changed after approval by the supervisor. An FDA quality system requires to come up with a corrective plan to address this shortcoming and validate a secure computer system.
Failure to implement formal risk analysis after software changes can be a serious violation of FDA compliance standards. FDA regulatory consulting services play an important role in detecting such fraudulent practices and necessary measure are taken to ensure fair practices. By complying with FDA quality system rules, the company could have reduced FDA compliance costs in the process.
It is therefore good to have a master plan for a company's quality operations, to prepare for future possibilities and growth in business.
