Doxis4 for pharma and life sciences
Every industry benefits from ECM software that allows its companies to fulfill regulatory requirements and optimizes business processes. Manufacturers and service providers in regulated markets are required to maintain and manage regulated documents, e.g. for specifications, studies, approval documents, production procedures, processing and packaging directions, procedural documentations and logs of the production processes, in a defined and controlled documentation system.
Doxis4 by SER helps you to fulfill all documentation obligations. It also helps you to minimize risks and manage secure procedures, regardless of whether they are in standardized processes or flexible case processing. Doxis4 is the strategic platform for company-wide enterprise content management, also in regulated markets.
- Documentation must be clear, correct, up-to-date, complete, traceable and verifiable at any time.
- Companies must ensure that regulated data and documents are not being manipulated.
- Modifications must be well founded, transparent and clearly attributable.
- Documents need to be stored in a reliable way and constantly accessible throughout their required retention period.
- Document management processes (creating, verifying and releasing, processing, printing and distributing, deactivating) need to be checked and well documented by every company.
- Document access must also be monitored and logged.
- Relevant media data or electronic signatures of a document need to be indissolubly connected and easily readable.
- Standard operating procedures (SOPs) must be demonstrably distributed to the appropriate positions/personnel and kept up-to-date.
Flexible process mapping
To flexibly map regulatory process requirements, Doxis4 Task & Process Management provides an agile, hybrid business process management software for standardized and ad hoc processes — regardless of whether it is approval or distribution processes of SOPs or the flexible mapping of CAPA and deviation management processes. The figure on the right shows you further process examples.
Two major criteria for choosing a software solution in regulated markets are the validation of processes and the deployed software components. Validation here means proving that the principles of good automated manufacturing practices (GAMP) are met and that procedures, processes, equipment, material, operations or system actually lead to the expected outcomes. Over and over again, Doxis4 has successfully proven its suitability here and has been validated as such.
An experienced team of specialists supports you throughout the project in validating according to GAMP and helps you to create documents according the V-model based on SER's existing standard documentation.