Quality documentation

How much time do you invest in managing your quality documentation? For example, can you check who has read a critical policy document? With Advantum, you ensure the right people always have access to updated and approved quality documentation.

With Advantum, you can automate and simplify management of your quality documentation and processes. Thanks to Advantum’s configurability, tailoring processes to fit your needs and demands is easy.

The examples below illustrate the standard functionalities in Advantum that are used to improve efficiency in managing quality documentation:

• The creation, evaluation and approval process
• Change management – Change Request and Change Order
• Audit trail with real version management
• Electronic Signatures and Electronic Records
• Permissions management – group, role and status based
• Complete control over which documents affect other documents
• Complete control over which documents are included in various processes
• Alarms for periodic evaluations and similar with escalation options
• Automatic message controls for tasks to be carried out
• Pre-defined lists of options and mandatory information boxes
• Integrated with MS Word, Excel and Outlook

Advantum contains functionality necessary to meet and comply with requirements in most quality systems, regulations, and standards. These include: ISO 9001, 14001, EU-GMP, ICH, cGxP, FDA 21 CFR part 11 and 820, Medical Device Directive 13485 and more.