Pharma
The GxP Cloud Computing Environment
Arctive.PHARMA accompanies the life science and pharmaceutical industry!
Specialists in medical, pharmacy and pharmaceutical chemistry are currently facing a multitude of fundamental challenges. Secure data quality and integrity, time-accurate and correct traceability throughout the entire life-cycle of a product, increasing GxP requirements, and the guidelines and regulations of Swissmedic, among others, that must be taken into account are THE buzzwords.
We create consistent, efficient control mechanisms and process automation!
Arctive.PHARMA is designed as an experience layer with easy integration into IT systems such as EDMS, QMS and LMS. All stakeholders such as system and service owners, quality managers, process owners, compliance officers, CSV experts as well as project and validation managers, benefit from the intelligent and easy handling of cases with Arctive.PHARMA
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Arctive is an active full member of the ECA Foundation.
- Easy update in IT systems by accelerating computerized systems validation (CSV) and periodic tasks.
- Agility of modern cloud platforms and upgrade cycles while maintaining a securely validated state.
- Supports project quality with a turnkey and efficient process for implementing new IT solutions.
Highlights
Turnkey
Arctive.PHARMA comes with turnkey best practice workflows and solutions that can be customized to individual needs and requirements.
Swiss Quality
Arctive.PHARMA is a Swiss solution.
All processes are clearly defined, consistent and well documented. Critical process steps are marked and all processes are stringently validated and subject to change control.
GAMP
Arctive.PHARMA is aligned with GAMP levels and can be easily adapted to our customers' SOPs.
Recurring tasks
Arctive.PHARMA supports periodic task tracking and ensures the execution of internal controls, including proof of execution and results, as well as reporting.
Built-in validation
In Arctive.PHARMA, validation and revalidation are integrated into the solution, but separate from other processes of the platform. There are no dependencies and blockages during updates. Secure validation in an agile cloud environment is possible.
Handovers
Arctive.PHARMA facilitates the efficient handover of projects to operations, mitigates risk, and reduces the time required to test and qualify IT systems.
Workflow
ServiceNow® is workflow-driven and guides users with flexible processes and approvals. This enables new employees to become productive quickly.
User and process errors are significantly reduced.
Integrated
Arctive.PHARMA is built to be easily integrated with all types of pharmaceutical IT systems such as EDMS, QMS, LMS or other pharmaceutical solutions.
ServiceNow® supports all modern technologies and integrates easily with any type of IT system (LDAP, AD, SAP or other solutions).
Fully audited
ServiceNow® has audit-proof archiving and full auditing (everything is logged) that ensures the integrity of all data.
electronic signatures and EDMS
ServiceNow® has robust, integrated user management and supports digital, electronic signatures, e.g. with DocuSign.