Our Compliance Proposals should fulfil your needs and your professional expectations - even at this early stage of a possible project work.
Our proposals do contain already a full solution approach and strategic program, which will be implemented by professional project and program management leaders.
Our success is based on professional project setup, implementation, verification, control, and hand-over processes. Based on our skills and knowledge combined with a professional project approach, our results are efficient and sophisticated at any stage of the consultancy service package.
We are supporting pharmaceutical companies to comply with different applicable regulations.
We offer high quality, advanced consultancy and solutions for the healthcare, medical device and pharmaceutical industries.
CCS is dedicated to serving the patient, the medical community, and the pharmaceutical industry with the best practices of services. We recognize our ethical responsibility to the patients and community.
We are analysing your project requirements for resource management, reporting, technical and procedural needs, scheduling, and regulatory compliance issues.
Each project with CCS will be managed by a project coordinator - irrespective if it is a small or big project. Periodic reviews and status reporting do guarantee the success of the project execution and to fulfil your strategic goals.
Our professional project coordinator will create together with you an inexpensive and flexible road-map to compliance. We define structured working packages, project plans, deliverables, project roles, responsibilities (RACI), and communication between team members and subject matter experts.
We assist you in getting ahead with your business challenges, clear project success and personal career.
comes compliance services (CCS) offers different concepts, strategies, and methods for compliance management:
Quality System / PQS integration (GLP, GCP, GMP, GVP, GDP), CAPA, GxP datability integration and governance, audits and inspections management, IT / application validation (ISPE GAMP 5) incl. Annex 11 and 21 CFR Part 11 compliance programs, software development life cycle e.g. according IEC 62304, Audit Service Center (third party audits / shared audit programs), Project Management, Pharma 2.0 implementation (Electronic Batch Recording, Paperless Lab, ELN, Data Warehouse), Infrastructure Qualification & Security.
How does validation work? DQ, IQ, OQ, PQ - this is not what you want to read here again and again. Just about every school of thought relative to validation includes the standard approach of Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
Validation is very often seen as additional extra-work without any added value. In our opinion and understanding Validation is the normal operational result of Good Engineering and Project Management Practices.
Validation needs to be totally integrated into the Quality Management System and the project planning & execution manual - policies and procedures for good practice, e.g. according ISPE GAMP 5 incl. second edition from 2022.
Our CCS experts work with you to look at the organisation holistically in the light of best practices and your existing policies, procedures, processes, and applicable regulations.
From that starting point, we will help you plan a risk-based route that lets you take consistent steps to achieving the results you need. Then we help you take those steps, using proven services and methods to gain the benefits of a consistent, value-added approach to compliance.
Top-down and bottom-up approaches are both strategies of information processing, compliance integration, and knowledge ordering.
The Audit Service Center (ASC) is an independent provider of value-added regulatory quality and audit management services.
Starting with the existing compliance programs of our clients we optimize such programs and manage quality audits of manufacturers of materials, products, components, and services providers, in GMP, GCP, GDP, GLP regulated industries such as pharmaceuticals, biologics, medical devices, cosmetics, dietary supplements.
Our team of highly dedicated quality experts delivers to our clients actionable strategic decision systems, improved supply chain processes and inspection readiness.
The Audit Service Center implements tested and proven strategies, tools and methods to cut costs and increase profitability of compliance and audit programs.
Our customers benefit from a partner (‘comes’) who provides a high level of compliance services in a professional and responsive manner.
Our capability to meet our customer’s requirements can be most clearly demonstrated by our consultancy and compliance models.
We manage our client’s expectations to the highest level of satisfaction from regulatory requirements gathering through project and program closure. We deliver these services through our extensive network and subject matter experts - a team of dedicated and knowledgeable consultants.
And in doing these things we help the pharmaceutical industry to develop, manufacture and deliver high quality pharmaceutical products to the patients including inspection readiness.