Quality Management


Quality Management

Management of SOPs and protocols

Industry challenge

In a Quality Management system a lot of documentation activities take place within you organization: writing and evaluation  of quality manuals and standard operating procedures, writing audit plans and reports, registration of follow up and more.  These activities are executed by the members of your quality control circles, which brings about several challenges.

First,  documentation is mailed back and forth or is up- and downloaded from your Document Management System (DMS), each  time a member has made a change. Not only is it difficult to keep track of the latest version of all content, it also means only  one person at a time can work on the final document.

Secondly, not all members have equal rights in the authoring process, 
yet with current solutions, enforcing this requires many work arounds. This is not only true for the document level, but also the section level, as rights can differ per section. 

Thirdly, when one member asks another to review 
content, the former has to wait for the review before the process can be continued.

Author-e QM solution

Author-e is a Document Management System with  integrated collaborative authoring functionalities. It  represents our answer to applications such as Google Docs  for collaborating professionals, by enabling simultaneous  editing combined with tracking functionalities to monitor the  documentation process. For quality management, this can assist in:

  • Quality assurance. By eliminating copy-pasting and version inconsistencies, the organization can be assured that throughout the organization the latest versions of SOPs and protocols are being used. Furthermore, the distribution of these procedures can also be arranged within Author-e, by publishing documents to HTML or PDF. 
  • Quality control. By performing audits with audit checklists that are dynamically linked to norms and legislation, Author-e ensures that quality controls are performed efficiently and effectively. Furthermore, due to digital signatures, errors can also be traced back to users, ensuring accountability. 
  • Quality improvement. By embedding instead of copy-pasting re-usable texts in procedures, all changes to them are reflected in all procedures that use them. 


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Create, review and approve documents. Using workflows and tasks, insights in progress of process and audit documentation can be gained through the notification center.

Multi-channel publications. Process documen-tation and reports can be published to multiple formats, such as Word, PDF, e-Pub, HTML and XML. This ensures any organizational requirement regarding publications can be met.

Central layout management. Templates and centralized standardization of fonts, font size, captions, text alignment and spacing ensure that all your documents are consistent with your corporate identity and organizational standards. Forms can be used to standardize data input.

Reusability of content. Sections and documents, such as ISO, NIAZ and JCI norms that we provide but also your own documents, can be embedded in other documents. This enables modifications to documents to be reflected in all documents that use them, eliminating double maintenance, copy-pasting and confusion about what is the latest version.

 

Simultaneous writing. Authors can work on the same document at the same time. This prevents locking of documents, thus increasing efficiency.


Version control. All previous versions of documents and files are retained, and can be restored if necessary. This is absolutely necessary to comply with norms and legislation, and allows you to look back at documents that were effective in the past.

User access management. Roles & rights can be defined not only at the document level, but also at the section level. These rights are automatically inherited to sub-sections. This allows enforcement of refined access policies.


Digital signatures. Workflows can be coupled with digitally signing off tasks. This, combined with version control, ensures traceability of actions, as well as accountability.