Quality Assurance Processes

A MAJOR CHALLENGE...

Managing typical quality assurance processes is a major challenge as there are so many different dependencies to consider and large numbers of people are often involved in a process. Many processes are also running for a long period of time, for example because preventive actions can only be implemented at certain times.

The BM-Flow "Managed Processes" module enables you to easily map the typical characteristic features of QA processes in your company. The processes and relationships shown in the graphic on the right are just a selection - in principle you can map all the required processes and their dependencies with our product.

The integrated Workflow Designer enables you to adapt the examples supplied for deviation management, specification deviations, corrective and preventive actions, complaint management and pharmacovigilance to your company's specific requirements.

The input forms for the individual processing phases can largely be freely designed. It is also possible to access existing IT systems, for example to provide a list of only active batches or to generate an item list. All changes affect the reporting level. The reports can also be freely adapted to your requirements.

There are close links with the "Managed Documents" module at all times, e.g. so that a corrective action can refer directly to the affected SOP. All entries in the forms are subject to an audit trail. The individual forms can be given a secure electronic signature.

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Quality Assurance Processes

A MAJOR CHALLENGE... Managing typical quality assurance processes is a major challenge as there are so many different... » more

SOP and Training

Are you on the verge of losing track of your stock of SOPs? Which draft belongs to which published version? Has there... » more

Managed Documents

Qualification documents, validation documents, electronic lab journal, audit plans, audit reports, maintenance plans,... » more