FDA 21 CFR Part 11 Compliance
Overcoming the challenges of satisfying FDA 21 CFR Part 11 regulations at an optimal cost requires the deployment of creative, innovative IT solutions. Electronic record-keeping has become an indispensable component of quality management systems across all manufacturing industries, but FDA 21 CFR Part 11 regulations complicate the documentation challenges specific to the medical device industry. By deploying the IQS software solution, you will be able to develop an enterprise-wide framework to manage your FDA 21 CFR Part 11 compliance initiatives.
The scope of FDA 21 CFR Part 11 focuses on the proper management of all electronic compliance documents specific to the medical device industry. To overcome this compliance challenge efficiently, you must be able to identify which electronic records and signatures apply to your enterprise’s compliance initiatives. By providing an integrated single interface, IQS software allows you to create, maintain, modify, retrieve and retain all documentation to satisfy FDA 21 CFR Part 11 regulations.
As the technological evolution of medical device industry continues to accelerate, government regulations will likewise surely expand. Quality management systems must be able to accommodate all validation and auditing requirements of FDA 21 CFR Part 11, in addition to accounting for issues related to the enterprise’s legacy systems. IQS software provides you with an enterprise-wide framework to overcome this aspect of FDA 21 CFR Part 11 compliance initiatives.
Identifying which records apply to FDA 21 CFR Part 11 regulations is merely a starting point when developing IT solutions specific to your enterprise. Regulatory compliance systems must be able to provide search, sort and provide copies of records to preserve the integrity of document content. IQS software features the functionality necessary to solve your FDA 21 CFR Part 11 compliance issues.
Learn more about the core IQS processes: