In the life science and other regulated industries, quality is critical at all stages of the development process - from drug and medical device development to industrial manufacturing and marketing. To ensure patient safety and consistent quality, companies are required to control all manufacturing processes and comply with regulatory requirements.
A company-wide quality management system covers all processes in all phases of development through to production and product monitoring after market launch. The core of the systems is the quality module for managing deviations, the resulting CAPAs (Corrective Actions, Preventive Actions) and change management (Change Control). This is supplemented by modules for complaint management, audit and inspection management, supplier qualification and training management. Depending on the requirements, there are other processes that can also be mapped in the system.
We have made it our business in Enterprise Quality Management to support and make more efficient quality management as well as compliance of regulated companies with the help of software systems. Information and data are integrated in order to be used jointly by different departments and business units. Through intelligent and direct evaluation of KPIs, errors can be detected in the future before they occur. The consolidation of systems also reduces the number of systems and interfaces to be managed.
Based on your business processes and specifications, we create development, validation and production systems as part of the consulting, prototyping and configuration process. In the process, we implement interfaces to DMS, ERP and CRM systems and migrate existing data. In daily project use, our consultants additionally support your team in the realization of extensions and adaptations, in administration and reporting. With us, you are not bound to one software solution. We support you with Sparta Trackwise/Trackwise Digital, Veeva Vault as well as Generis CARA.
We know the legal requirements and how they can be implemented efficiently. From project initiation with vendor selection to process analysis and definition to implementation with subsequent operation. When implementing your company-specific requirements, we guarantee high flexibility and efficient execution.
Sparta Systems, a Honeywell Company – TrackWise and TrackWise Digital
Quality management in highly regulated industries is confronted with permanently increasing requirements and regulations for quality assurance and compliance. At the same time, there is ongoing economic pressure to increase operational efficiency while complying with these quality assurance requirements. This is precisely where the benefits lie in using the TrackWise and TrackWise Digital enterprise quality management systems (EQMS).
With Sparta Systems' market-leading EQMS TrackWise and TrackWise Digital, compliance with these requirements can be fully demonstrated, documented and assured over the long term.
As the first Sparta Systems implementation partner in Germany, Inconsult offers extensive TrackWise expertise and in-depth knowledge of the QM and GxP processes required to implement and support your TrackWise projects. By using Inconsult consultants for Enterprise Quality Management projects with TrackWise, you are relying on German-speaking specialists who have a direct and cooperative relationship with Sparta Systems.
Veeva Systems - Vault Quality Suite
Veeva's cloud-based platform provides solutions for all pharmaceutical application processes in the regulated environment, from the clinic to distribution. All Veeva Vault applications are based on the same platform, ensuring a consistent process flow and user experience.
The Vault Quality Suite provides seamless management of your quality processes, content and training, consolidating them into a single source of quality information. The suite includes Vault QMS, Vault QualityDocs, Vault Training, Vault Product Surveillance and Vault Station Manager.
Inconsult is a certified Veeva partner and one of the first Veeva partners in Germany. We also support and advise you on other Veeva Vault solutions. For example, see how we can support you in Enterprise Content Management or Regulatory Affairs.
The Generis CARA Life Sciences Platform is currently used by more than 600,000 business users worldwide. CARA is a comprehensive platform for all life sciences applications, from early development and clinical regulatory affairs to safety and quality.
CARA is more than a document management platform that unifies different life science domains under one roof. With its unique Data Document Continuum approach, CARA enables more holistic and interchangeable data and document management, with the goal of enabling process optimization and transformation. This is based on the fact that documents contain data and data is used to create documents, so ideally both should be part of the same platform.
Our consultants and developers are CARA certified. Inconsult helps you streamline, standardize and automate your processes in Generis CARA. This can reduce costs and increase efficiency.