IT Consulting
From day one, choose an IT partner who understands your processes and provides forward-thinking support.
- Analysis, planning & implementation of efficient and future-proof network architectures
- Professional IT project management – from planning to execution, on time and on budget
- Future-proof IT infrastructure – from cloud migrations to fully validated systems
- Reliable IT lifecycle management – ensuring operational security in regulated environments
- Compliance-driven IT projects – including qualification and validation for GxP and beyond
Improve your IT structure
- handshake’s structured planning approach minimizes production downtime during IT migrations – or even allows them to be carried out during regular operations.
- Qualified support from the decision-making phase onward – with expert guidance on required updates and assistance in keeping your computerized systems and IT infrastructure up to date.
- We provide level 2 and level 3 to support your internal organization during project execution and operatioins.
- We manage complex, cross-departmental tasks that demand both technical expertise and strong communication skills.
Ensure compliance to regulatory obligations
- We help clients meet regulatory requirements by ensuring that critical information for audits, documentation, and quality assurance is readily available and well-structured.
- Continuous updates, secure documentation, and a streamlined approach help meet all regulatory requirements – while keeping the documentation workload to a minimum.
- Audit- and compliance-relevant information can be searched and accessed at any time to support accurate, detailed responses during audits or legal proceedings.
- We reduce review workload without compromising the required review quality.
Validation and Qualification
- Create complete validation documentation in accordance with GxP guidelines – including validation plan, risk analysis, test plans, and reports.
- Together with the customer, we develop a standardized qualification approach (DQ, IQ, OQ, PQ) tailored to each system type and production process.Our products offer flexible integration with existing computerized systems, assuring a continuous data flow that safeguards and extends the value of your previous investments.
- Our experts perform the required tests to qualify the systems for GxP-compliant operation.
- All results are documented in close coordination with the quality departments to ensure full compliance.
- At the end of the process, the local quality managers approve the system for use – with a fully audit-proof validation report.
Frequently Asked Questions
How long does a typical project take?
IT and network projects in GxP-regulated environments require thorough and meticulous planning. The lead time is determined by the scope of the project, as each impacted system must be individually assessed to prevent unexpected issues during implementation. Execution typically occurs within a live production environment, with minimal downtime. Depending on the specific requirements, both phased rollouts and “big bang” implementations can be effective approaches. Additionally, the qualification of newly implemented or migrated systems may require significant time and effort.
Extensive documentation requirements, qualification planning, execution of test cases, and proper documentation of successful testing can significantly extend the overall project timeline. Additionally, updates to existing Standard Operating Procedures (SOPs) or the creation of new SOPs for new systems must be taken into account.
What types of organizations does handshake primarily work with?
handshake primarily partners with global leaders in the pharmaceutical and process industries, while also supporting many clients in the SME sector. The majority of projects focus on addressing complex challenges in GxP compliance, ensuring data integrity, and delivering critical infrastructure solutions within R&D and manufacturing environments.
What is required for project preparation?
Collection of basic project information
Identification of all relevant stakeholders
Kick-off workshop to align all participating organizations
In-depth assessment of system-specific conditions
Detailed planning of the target scenario
Definition of the steps required to reach that scenario
Assignment of responsibilities for each project step
Evaluation of internal resources or identification of external implementation partners
Development of a detailed project plan
Approval of the subproject plan and confirmation of the implementation costs known at that point by the client
Final Go/No-Go decision
What are the critical factors in project execution?
Strict adherence to the timelines defined in the project plan, weekly update meetings to ensure continuous progress, and ongoing communication with all organizations involved in the implementation.
How do projects in the GxP environment differ from other projects?
In addition to technical requirements, GxP projects must also meet Quality and Compliance standards. The responsible persons from each organization are identified as stakeholders at the start of the project. From that point on, they are involved in ensuring that all requirements are met and that all tests necessary for the qualification and validation of the target scenario have been carried out.
Knowledge Center
The handshake Knowledge Center offers in-depth resources on our IT Consulting Projects.
