Compliance & Validation
Innovative methods
Innovation and Validation - made by Inconsult, we apply several highly efficient tools to validate software at the cutting edge. In this way, we actively shape the future of the regulated industry and our customers benefit significantly from the novel consulting approaches. The use of sophisticated tool chains, for example with the help of JIRA / Zephyr, Siemens Polarion and Git Repositories, are just a few highlights from our toolbox.
Cutting Edge Expertise
The active co-design of industry standards is a unique selling point of Inconsult validation consultants. This ensures that extensive competencies are available for all innovation drivers of digitalization. We actively steer the development of up-to-date standards for important topics like cloud validation, compliance in the use of DevOps, the use of Artificial Intelligence and the validation of interfaces.
Proven consulting guidelines
Our consultants are active members of the ISPE GAMP DACH Forum and contribute to the success of Special Interest Groups (SIGs). This involves the following topics:
- Artificial Intelligence Validation Approach
- Validation of interfaces
- Validation of Open Source Software
- Agile software development methods
- Audit trails and their reviews
- Harmonization with the guidelines for medical devices and pharmaceuticals
The latest insights and best practices are described in the VDI guidelines and ISPE publications, e.g. Pharmaceutical Engineering.
Holistic Application Lifecycle Management
A holistic approach to the validation of computer-based systems is essential. Our experience shows that this is the only way to provide sustainable consulting services in a regulated environment. Holistic application lifecycle management means clarity about what needs to be done when and why.
The complexity of lifecycle-based validation is managed by anticipating the side effects, consequences and interactions. Interrelationships are clear at an early stage and errors are anticipated through appropriate risk analysis. This approach requires risk awareness and leads to increased productivity and cost savings in the medium and long term.
Validation & Consulting
The knowledge of the above characterizes our validation consultants. This enables them to focus on the essential aspects of risks and good compliance. This results in targeted, determined action - right-sizing in the consulting approach, which enables sustainable implementation of legal requirements.
Legal rules, values and standards of the industry correspond to the foundation and are a basic requirement for good compliance. It is particularly important to understand and evaluate the purpose of regulatory requirements beyond the legal text.
Industrial process and IT expertise
We ensure that precisely fitting and intelligent approaches to setting up and controlling devices and systems are established. Such a risk-based approach enables validation and operation to be maintained in a cost-saving manner.
Our consultants are distinguished by their extensive industry knowledge. Decades of project experience in the regulated environment have provided expertise ranging from industrial processes to IT systems.
IT system Competencies
- Laboratory Information Systems, e. g. Abbott, LabVantage, LabWare, SAP, Thermo Science, Waters
- MES - Manufacturing Execution Systems, e. g. Körber PAS-X MES
- Enterprise Resource Management, e. g. SAP R3 / S4HANA, Microsoft Dynamics Navision
- Product Lifecycle Management, e.g. Dassault Systems
- Application Lifecycle Management, e.g. Siemens Polarion, Atlassian JIRA, ValGenesis
- Regulatory Information Management Systems, e. g. ArisG
- Submission Management. e. g. Lorenz DocuBridge
- Corrective and preventive actions (CAPA), Deviation / Complaint, e.g. Veeva Vault QMS
- Quality Management e. g. Trackwise, Veeva Vault QMS
- Document Management, e. g. Opentext Documentum, Life Science Industry Suite, Veeva Vault Qualitydocs, Generis CARA, FirstDoc, Biovia Qumas, Schema ST4
- Robotic Process Automation (RPA), e.g. UIPATH
- Machine learning (Artificial Intelligence), e.g. Google Cloud NLP API, Amazon Comprehend, Python
Best Practice was yesterday - Best Thinking is today, for tomorrow - with Inconsult
Validation Services
Change Enabler Data Integrity
Digital strategies can only be successfully implemented if the integrity of data is ensured. Data integrity is therefore not exclusively a regulatory requirement (GDPR, Data Privacy, MDR, ISO 13485, CFR Part 11), but a transformative element for the future of any successful IT strategy. Companies in the regulated sector can take advantage of this insight.
Since 1997, applicable government regulations of US 21 CFR Part 11 and EU Annex 11 have become significantly more stringent. Good data compliance can help to avoid critical findings during inspections by authorities or customers.
Our consultants can help you implement data integrity requirements for computerized systems. The goal here is to ensure complete control of data throughout the system lifecycle and data lifecycle: from implementation, to system operation, to decommissioning. At the same time, the system must have functions that allow data to be retrieved at any time.
To meet these requirements, Inconsult offers a wide range of review services. The many years of experience of Inconsult consultants in carrying out these reviews also lead to support tailored to your needs.
Operational Excellence
Inconsult ensures that core processes in the regulated environment are designed effectively and efficiently. With the help of modern, customized project and validation approaches, massive quality increases are achieved in demanding digitization projects and change programs.
The goal is to achieve "operational excellence" through the application of agile processes and the use of SMART methods. Our claim is to go hand in hand with your strategic alignment, thus having a positive impact on operational costs.
Inconsult achieves this by designing regulated processes in such a way that functionalities of the deployed solutions are optimally utilized. It is particularly important that regulated companies are positioned for the future in order to meet the constantly changing requirements of the VUCA world.
Compliance Services
Constantly changing requirements for compliance with data integrity as well as new technologies in digitalization present ever-growing challenges in the regulated environment. Our goal is to assure the functionality of computerized systems and to provide complete proof in case of inspections and audits.
As a result, Inconsult consultants ensure that legal and regulatory requirements are met throughout the entire system lifecycle: from the implementation phase to decommissioning. In addition, project runtimes are shortened by our competencies and the workload of specialist departments is reduced. Cost structures over the entire system lifecycle thus become transparent and plannable.
Through our participation in committees of the ISPE and VDI/VDE, and the GAMP DACH Forum, we anticipate the latest trends and developments in the GxP environment in coordination with specialists from the pharmaceutical industry, medical device technology and authorities. This leads to knowledge leadership and added value to all Inconsult customers.
Computer Systems Validation - CSV
The validation of computer-supported systems is the basic prerequisite for meeting data integrity requirements for electronic data. Inconsult brings the necessary expertise to all issues related to open source software, cloud computing, agile project management and tool-based validation. With common sense, also know as "critical thinking", and the right solutions for you, achieving compliance becomes valuable instead of expensive. Inconsult consultants are skilled in requirements analysis and gathering, system selection, vendor qualifications, and validation deliverables such as specifications, risk analysis, traceability, and test concepts, plans, and execution.