How to validate Software Development tools used for GXP and MedDev? Join our Event on 27. November 2018 - Read More: Event
when IT comes to compliance...
comes compliance services (CCS) is a consultancy service provider for the regulated industries.
CCS provides professional services to clients of pharmaceutical manufacturing (GMP ), medical devices, R&D and clinical studies, pharmacovigilance, eCTD, distribution, storage and logistics or similar areas.
Our consultancy concepts and expertise is based on an inimitable combination of regulated expert knowledge and innovative IT solutions, in order to implement efficient and modern quality systems and processes for our clients. CCS is the best service candidate as third party auditor for your data integrity program and PQS & data governance system.
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.
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.
comes compliance services (CCS) is an independent, highly experienced, and premier consultancy service provider specializing in simplifying and streamlining EMA, FDA, ICH, GHTF quality systems, and fulfilling validation and regulatory compliance requirements. At CCS, we strongly believe that quality and GxP compliance management will drive continuous improvement and performance optimization. We utilize a more pro-active and risk-based approach to quality assurance backed by proven expertise and electronic tools from our partners. We focus on value-added project, process and risk management to achieve regulatory compliance and inspection readiness.
Minimize risks, lower costs, and speed up your time to market with strategies, policies, and controls that improve your compliance and contribute to your bottom line. Our services are backed up by theoretical resources and thorough regulatory knowledge. They will be demonstrated through practical examples and explained and implemented by experienced professionals.
What to do next?
If you would like further information on any of our services and solutions, arrange a meeting or to talk through your specific requirements that we can help you with, please get in touch. Contact us today and find the solution for tomorrow.
The Swiss Working Group of Information Technology (AGIT, Arbeitsgruppe Informationstechnologie) consists of representatives of the GLP Compliance Monitoring Units and of invited experts from the industry. Several documents related to information technology in a GLP environment (status of 31.01.2018) have been developed and can be downloaded (source: admin.ch) here: Download link (external link) Thanks to the …
Industrie 4.0 – What does this mean for Medical Device and Life Sciences Innovators Join leaders and industry experts at the 6th PTC Executive Exchange for Medical Device and Life Sciences Innovators. Together, we explore how IoT technology: Increases transparency and advances efficiency to further ensure medical device quality. Impacts the way medical devices are …
Behörde und Industrie im Dialog Erfahren Sie bei diesem Seminar wesentliche Zusammenhänge der strategischen Planung und Verwaltung von GMP-Daten. Im Wechsel präsentieren die Referenten aus Behörde und Industrie gesetzliche Anforderungen und Lösungen. Mehr Informationen zum Event – externer Link
You will understand the purpose and organisation of regulatory inspections and you will learn how to prepare your company to pass an inspection or customer audit and how to assure the most positive outcome. Read more (external link)
Die Medizintechnik- und Pharmaindustrie stellt höchste Ansprüche an die Sicherheit für Patienten und Anwender, bei der Prüfungsdurchführung und bei nachvollziehbaren und geschützten Daten. Zudem muss die Produktsicherheit während der Entwicklung, Produktion und Qualitätskontrolle stets im Fokus stehen und durch geeignete Prüftechniken nachgewiesen werden. Das Zwick Roell Symposium am 13. Juni 2018 bei Zwick in Ulm …
After the British agency MHRA has published three (3) different draft versions of the – MHRA GMP Data Integrity Definitions and Guidance for Industry – in January and March 2015 (GMP) and in July 2016 (Draft for consultation – now for GXP) the final “Medicines & Healthcare products Regulatory Agency (MHRA) ‘GXP’ Data Integrity Guidance and Definitions …
After our successful event on 8. February 2018 we have planned to repeat it on the 27. November 2018 in the city of Stuttgart, Germany. Based on the input and feedback from the initial event we have improved several sessions and added a guest speaker. Read more: Registration and Information page If you have any …
LOGFILE Nr. 02/2018 – Regulatorische Anforderungen an ein elektronisches Chargendokumentations- und Freigabesystem Welche regulatorischen Anforderungen sind bei der Umsetzung eines elektronischen Chargendokumentations- und Freigabesystems (EBR) zu beachten? Lesen Sie hier mehr online (externer Link)
Das Seminar wendet sich an alle Sachkundige Personen/ QPs. Ebenfalls angesprochen sind Leiter und Mitarbeiter von Qualitätsmanagement und Qualitätssicherung und Mitglieder der Unternehmensleitung, die einen umfassenden Überblick über Pflichten und Aufgaben der sachkundigen Personen/QPs erhalten mochten: Qualified Person Update 2018 – Neues für die Sachkundige Person in Deutschland; 19./20. April 2018, Mannheim Zum Online – …