Document control is a critical aspect of quality management for any organisation, particularly for those in heavily regulated industries like healthcare, pharmaceuticals and medical devices. In these industries, inspections by regulatory bodies are a routine part of doing business, and the consequences of failing an inspection can be severe, including costly fines, product recalls, and even suspension of operations.

Make sure documents are up to date. One of the most important functions of document control is ensuring that all necessary documentation is up-to-date, accurate, and accessible to the appropriate personnel. This includes procedures, work instructions, specifications, and other documents that are critical to the production of safe and effective products. By maintaining accurate and up-to-date documentation, you can ensure that their operations comply with regulatory requirements and be prepared for inspections.

Versions need to be monitored. Document control also plays a key role in maintaining version control, preventing unauthorised changes to critical documents, and ensuring that all changes are tracked and documented. This is particularly important in heavily regulated industries like healthcare, where changes to procedures, equipment, or materials can have significant implications for product quality and safety.

During inspections, regulatory bodies will typically review an organisation’s document control system to ensure that all documents are properly controlled, that changes are documented, and that the latest version of each document is being used. A robust document control system can help you to pass inspections by demonstrating that there is a strong quality management system in place and that you are committed to maintaining compliance with regulatory requirements.

Genial’s iPassport solution has a document control module making it easy to track and manage documents. It has the following capabilities:

  • Centralised repository for controlled documents
  • Automated document review and approval process
  • Change requests
  • Fully compliant electronic signatures
  • Controlled printing
  • Staff acknowledgments
  • Complete record and review history

iPassport takes the guesswork out of managing policies and procedures. I know my employees have the most recent version in front of them at all times. I can’t wait to get deeper into all of the additional Quality Management tools included in iPassport

Roger Sealy, Houston Department of Health

Document control is a critical component of quality management for organisations in healthcare and a key part of achieving and maintaining ISO 9001, 15189, 1725, CAP, FDA regulations, GXP and more. By maintaining accurate and up-to-date documentation, preventing unauthorised changes, and ensuring version control, you can demonstrate commitment to compliance and prepare for successful inspections. A robust document control system can help you to avoid costly fines, product recalls, and other consequences of non-compliance, ensuring the continued success of your operations, and it also helps you to maintain accreditation.

Genial has over 40,000 users of iPassport worldwide in the healthcare sector and beyond. Find out how it can help with your quality management on our website or read a testimonial about how iPassport has been a ‘game-changer’ for one of our customers.

Keep in touch

If you’re interested in finding out more about Genial products and services, please follow us on our social platforms or drop us a line.