Control every change

Change control is the procedure a regulated company uses to propose, assess, approve and document changes to its procedures, processes, systems and products, so nothing changes without a reason, an impact assessment and sign-off. ISO 13485, FDA QMSR and ICH Q10 all expect it. In Qualio, every document revision carries its own change control.

Yes. Each approval is signed electronically with the signer's name, the date and time and the meaning of the signature shown on it, and every change to the change control is kept in its audit trail.

A change request proposes a change and asks for approval to make it. Change control is the whole process around it, from assessment and approval to implementation and the history of what changed. In Qualio, a document change request groups several documents, each approved on its own, and each revision keeps its own change control.

An impact assessment should cover which documents, processes, products, training and validated systems the change affects, any regulatory or product impact, and the risk of making or not making the change. In Qualio, every change request has an impact assessment, and Qualio suggests the documents linked to the ones you add so none are missed.

Group the affected documents into one change request, get it approved before drafting starts, revise each document through its normal review, and make them effective together so no SOP points to an outdated one. In Qualio, closing the change request can make every included revision effective at once.

Usually. Most procedures let clerical changes, such as typo or formatting fixes, follow a lighter path with no retraining, while material changes need a full impact assessment and approval. In Qualio you can set up a change control template for each type, and the author picks the right one when the draft starts.