The Medical industry faces complex regulations governed by multiple regulatory systems, and international and national standards. ISO9 offers the unique tools to help you reach compliance with industry-specific requirements, create standard operating procedures and set the path for continual improvement. Whether you're looking for an efficient and cost-effective solution to 21 CFR Part 11 or the medical device-specific ISO 13485, ISO9 has the answer.
ISO9 recognizes the rigid tasks and requirements at hand to comply with the FDA's Electronic Records and Signatures Rule 21 CFR Part 11. With real-time access, a collaborative platform and the tools to standardize your procedures and processes, we'll help your company quickly and cost-effectively comply to 21 CFR Part 11 requirements:
Ensure Data Integrity and Confidentiality
The secure environment of the ISO9 application gives you controlled access to all ISO9 databases, complete with password-protected, user-defined access.
Automate Electronic Signature Binding
Easily comply with 21 CFR Part 11 with authenticated users' signatures through a forced authentication process that requires users to log into the system and expose their signature each time a document is processed.
Document Extensive Audit Trail
The ISO9 solution automatically records modifications, approvals and deletions for every document and record. Audit trail information includes date/time stamp, electronic signature and any comments posted by reviewers.
Leverage the powerful functionality of the ISO9 application and integrate the requirements for 21 CFR Part 11 seamlessly into your ISO9-based system.
Improve foundation practices
Maximize data quality
Ensure system and data security
Ensure integrity of collected and stored data
Our quality approach to manufacturing ensures the Blood, Food, Medical Devices and Pharmaceutical industries adhere to the rigid guidelines of the FDA. With automated tasks and a centralized database, you'll simplify the compliance process and be on your way to placing quality products on markets throughout the world.
Address the specific requirements of the Medical Device industry with ISO9's solution to ISO 13485. Used in conjunction with ISO 9001:2000, ISO 13485 is designed to ensure companies produce and provide safe devices. Compliance to ISO 13485 requires the implementation and maintenance of a QMS appropriate for the production, installation and servicing of medical devices.
ISO9 helps you increase the safety and operational effectiveness of your operations with:
Customizable mode of feedback
Expedited and automated audit process
Collaborative, real-time platform for management review
Extensive training platform
