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Compliance & Consultancy Results delivered by CCS:
- Making compliance & validation requirements understandable and processes & systems ready-for-implementation: We helped a customer during system planning, development, testing, and implementation in their first pharmaceutical project. Methods and processes were properly estabilished - validation tasks were executable and manageable. Now the supplier is using this validation and project approach for all projects and areas.
- Working out a global core concept for system validation: We helped global pharmaceutical companies in the setup and realisation of system core concepts - validation and project approach, roll-out plans, centralized testing, and covering several local compliance requirements. Specific site validation and implementation plans reduced efforts and costs.
- Consultancy for new production sites: Validation Master Planning is essential for new production sites and structures. A detailed analysis of processes, methods, and production areas made project planning and resource management visible and possible.
- Audit follow-up actions implemented: Rapid implementation of corrective actions, so that our customer was able to close the deviation in a follow-up audit. Also preventive actions were taken to eliminate any recurrence.
- Assitance of supplier audits: We helped customers to execute vendor and supplier audits. We worked with the audit team to give them the knowledge and understanding of software development und release management. The customer was able to find the right supplier for their planned IT project.
- Eliminate the frustrations and costs of computer validation: We worked with the client's management team to give them the know-how and the confidence to determine the right level of IT compliance for their processes and products. Our risk-based validation methodology helped several customers reduce validation time and effort to ISPE GAMP.
- Make the audit process faster, easier and with fewer findings: Aligned controls, plans, and organizational accountabilities with business and compliance expectations, reducing audit findings from major critical to some recommendations. We try to get to the bottom of compliance and business aspects to find the best practicable approach.
- Bullet-proof our IT or Compliance projects. Rescued a project running two months behind and over budget. Within 30 days, the project was ahead of schedule and under budget. The planned go-live date was realized.
- Lower operational costs: Putting service and maintenance procedures and agreements into place. Assured electronic signature, service, back-up, desaster recovery, business continuity management, and user management processes.
- Improve business value and service: Analysing and improving general IT processes and software hand-over procedures. The business received better services and IT received more funding and freedom.
- Upgrading a company wide validation concept: Preparation of smart validation templates and execution of trainings for responsible persons. For spreadsheets alone, the validation effort was reduced from 15 to 3 "man-days".
- Providing an electronic Quality Management and Validation System: Selecting an electronic application for Quality Management, incl. implementation, validation, training, and go-live support, including hosting of the complete solution and outsourcing of the IT Management. This service enables customers to use the benefits of eDMS, Change Control, CAPA, and electronic validation processes.
- Supporting the preparation for inspections: Rescued a customer to receive major observations and findings by a coaching and implementation concept.