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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.

Services

  1. concept
  2. consultancy
  3. methodology
  4. scope of services
  5. validation
  6. CCS teams
  7. Audit Service Center
  8. inspection readiness
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.

From Best Practice to Next Practice

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.

e-Validation Platform (eVP)

Ensuring your computer systems are cutting edge is a critical factor in beating your competition. This can be achieved only with a modern and fast computer system validation (CSV) framework.

Our e-Validation Platform (eVP) designed to comply with the requirements set by ISPE GAMP®5 second edition (SE) and GAMP® GPG Enabling Innovation based on Atlassian Confluence and Jira is a milestone of validating computerized applications to ensure they meet the requirements of GXP. 

Our e-Validation framework is a critical step in ensuring that electronic applications, processes, equipment, cleaning and monitoring are reliable, accurate, and complete. It helps to prevent data integrity issues and ensures that the computerized systems, processes, risk assessments and project management are fit for their intended purpose by a holistic and comprehensive approach. 

There are several key steps involved in validation according to ISPE GAMP®5 second edition with Atlassian Confluence and Jira:

  1. Planning and Scoping: The first step is to plan and scope the validation project. This involves identifying the scope of the project, defining the objectives, and establishing a project and validation plan.
  2. Process, Data and Risk Assessments: Several levels of assessments should be conducted to identify potential risks to data integrity and to develop mitigation strategies.
  3. Design Review: The design of the computerized system should be reviewed to ensure that it meets the requirements of GXP processes and requirements.
  4. Development and Code Review: The code of the computerized system should be properly developed and reviewed to ensure that it is written according to best practice standards. This does also contain development test phases like unit, integration, and system testing before the release of a system version or patch.
  5. Installation and Configuration: The computerized system should be installed and configured according to the approved specifications.
  6. User Acceptance Testing (UAT): The computerized system should be thoroughly tested by users to ensure that it meets their needs and expectations.
  7. Formal Documentation: Formal documentation should be generated to document the validation process during project and operational phase.
  8. Ongoing Monitoring: The computerized system should be continuously evaluated and monitored to ensure that it remains compliant with GXP.

Atlassian Confluence can be used to support the e-Validation process in several ways. It can be used to:

  • Store and manage e-Validation documentation: Confluence can be used to store and manage all of the validation documentation, including risk assessments, design reviews, code reviews, UAT reports, and formal documentation.
  • Track e-Validation activities: Confluence can be used to track the progress of the e-Validation project and to record key milestones.
  • Communicate with stakeholders: Confluence can be used to communicate with stakeholders about the e-Validation project and to get their feedback.
  • Building a bridge between contract giver and contract acceptor (e.g.: development and configuration by supplier with Jira).
  • Implement ISPE GAMP®5 SE and Enabling Innovation requirements (e.g.: tools instead of documents, acceptance instead of approvals).
  • Use AI testing tools with Confluence for automated system and user acceptance testing.
  • Automated creation of Fit-Gap Analyses and Traceability Matrix.
  • Extend your Validation Master Plan with process, cleaning, equipment, utility, facility, and method validation and qualification.
  • Enables a total framework for project, process, risk, validation and supplier management and collaboration (e.g.: electronic Logbook Management, bridge to SOLMAN and eDMS/eQMS).
  • Fully inventory management (extension: CMDB), ITIL tools including patch and release history.
  • Full support of IT infrastructure qualification (ITIL, ISO 20000).
  • Compliance with EU GMP EudraLex Volume 4 Annex 11 and Annex 15 and US-FDA 21 CFR Part 11, GCP (EMA, FDA), GLP (OECD), GDP

Our CCS paperless validation approach is designed for reducing validation and qualification efforts.

Using our eVP with Atlassian Confluence in the entire validation and qualification process can help to improve efficiency and compliance. It can also help to reduce the risk of data integrity issues. 

A slow computer systems validation (CSV) is a roadblock on your path to success: It delays the deployment of improvements, the assessment of their impact, and ultimately, their value to your business. A quick feedback loop continuously drives better ideas and fuels your business with powerful breakthroughs.

What makes your solution unique? We do not offer a dedicated digital or electronic validation system; we offer a highly extendable platform approach close to software developers and system configuration and a high degree of regulatory compliance.  With our certified global Atlassian Solution Partner we can provide a fitting solution to any client and meet highest expectations.

What to do next? Contact us today at talk@comes-services.com

 

Choose your e-Validation tool and strategy from top-notch validation experts:

 

Test report and traceability:

 

Test execution:

 

Requirements and testing: