versiondog - Data management for the pharmaceutical industry
The national and international GxP regulations are there to ensure that medications and their active constituents are safe and meet their intended use. They impose a number of exacting demands on the production facilities of the pharmaceutical industry. versiondog helps pharmaceutical manufacturers adhere to the GxP rules of the various regulatory authorities (FDA, EMA, ...) with regard to process quality, documentation and proof of compliance.
- Increase production quality with automated support for GxP, FDA 21 CRF 11, EMA, ...
- Detect unauthorised changes
- Simplify process of verifying quality with audit trails at the click of a button
- Ensure clarity, certainty and safety in production with automated archiving of device data
- Increase consistency and quality in production due to the ability to precisely track changes and their release as modified control programs
- Save time thanks to standardised documentation
- Fulfil your Product Lifecycle Management (PLM) requirements through long-term archiving and availability of documented project data
- Full documentation of program and project change history ("who changed what, where, when and why?")
- Ability to compare any two versions all the way back to the base version (lifecycle management)
- Fast and reliable disaster recovery strategy through clear version & backup management ("which program version was running on the controller?")
- Alarm when discrepancies are found
- Workflow for change management using the two-person rule
- Archive manager for long-term archiving and availability
- Reports, logs, version identifiers and notifications
Today’s automated environments
Both networked and non-networked controllers and devices are in use. Multiple shifts have to be taken into account. There is a need to keep processes running at an optimised level. Both in-house staff and external contractors continually change, improve and troubleshoot software. Existing facilites are modified and new facilities are commissioned. All this is done using a wide variety of programming tools, and documentation is often still done manually. If data is not organised properly, it can be extremely difficult to find the right version of a control program, or to be sure about which version is running on a given device. This lack of clarity can adversely affect quality or result in downtime. And that can quickly become very costly.
versiondog brings order
DOCUMENTATION of changes according to quality management standards ISO 900x, GAMP, GMP, FDA 21 CFR 11 and VDA 6.4.
ARCHIVING of all project data with complete change history (audit trail).
AUTOMATIC BACKUP of device data according to a user-defined schedule.
AUTOMATIC COMPARISON of the control program project version with the version running on the device for equipment from multiple manufactures, including SIMATIC S5, SIMATIC S7, SIMATIC PCS 7, WinCC, WinCC flexible, InTouch, CODESYS, TwinCAT, Phoenix PC WORX, RSLogix, Schneider Modsoft, Schneider Concept, Schneider Unity, SINUMERIK 840D, Bosch IndraWorks, robot control programs from ABB and Kuka, Microsoft Word, Microsoft Excel, Adobe PDF and many more.
DISASTER RECOVERY made much faster thanks to the ability to precisely compare versions with SmartCompare.
LIFECYCLE MANAGEMENT supports projects through the design, programming and commissioning phases and in operation.
COORDINATION between in-house staff and external contractors using Supplier Check-Out and SmartImport.
You too can benefit from versiondog...
Our sales advisors will be delighted to answer all your questions about what versiondog can do for your enterprise.