Challenges in practice
A large number of standards in the QM area require the mapping of your documents as an integral part of your quality management system. In addition to the fulfilment of these standard regulations, the administration and control of process and procedure-related documents pose a number of challenges. For example, quality manuals and the associated documentation can create an unmanageable amount of work in digitalised environments.
Solution QS1
QS1 document management allows you to create/store all quality-relevant documents in an audit-proof manner. On the one hand, these are all QM-relevant documents that serve the effectiveness of your QA/QM philosophy; on the other hand, process-related documents in all QA work areas.
In addition to the SOP documents, QS1 allows you to assign any documents to each ‘object’, such as test orders, test equipment, FMEAs, batches, products, etc., organised by document type. Documents created in QS1, such as your acceptance test certificates, your welding certificates or batches approved by the QMB in the medical sector, are versioned and archived fully automatically in the DMS by QS1. Of course, the documents can be subject to document control. You can freely configure the guided process in conjunction with QS1 workflow management and the associated role authorisations. This includes digital signatures up to the 4/6-eye principle.
Does your ERP system also include a DMS system? Then QS1 allows you to display these ERP documents directly in your QA processes. You can also use QS1 to automatically check in documents in the ERP system.
- Documents/evidence as a condition for transactions
- Extensive document types and context-based default values for pre-assignment during entry
- Document properties - change management - document control - workflow - versioning
- Digital signatures / x-eye principle
- Location-independent access to necessary documents (mobile/desktop, master data/process data)
- Simple handling (drag & drop, Windows clipboards)
- Use across the modules used (from inspection to complaints)
- Automated creation of device accompanying cards via the recorded QA documents and test results in the entire structural context
- Document capture also in our portal solutions by suppliers or customers
- Direct access to all ERP documents for data used in QS1
- Recording of documents in QS1 and automated transfer to the DMS from the ERP system
- Outlook integration with options for signalling and sending reports by e-mail
- Full text search in all documents combined with the QS1 data
- Option for simple validation (based on GAMP5) of our standard software in an operational context
- The technology takes care of filing and administration in the background
- Central storage location for simpler backup model
- Extensive parameterisation (linking, typing)
- Full mail integration
