Cyberconseil - Le partenaire des Industries de la Santé

Project Package

STEPHENSON Sharleen — 2008-12-18T10:55:18Z

The CVO-CyberConseil technical support will take care of an entire project throught a close partnership with the customer. Thus you benefit from our complex projects experience and CVO-CyberConseil's capitalised expertise. This turns out into concrete guarantees about deadlines, budgets and quality.
Beeing able to bring together pluridisciplinary teams highly qualified in various fields is what boosts CVO-CyberConseil 's development.

Computerized validation management

MICHENAUD François — 2008-11-25T11:30:37Z

A pragmatic approach and an effective tool enable us to solve our customers' issues.

The combined use of the Validatool software and the expertise of our consultants makes possible to provide services with real added-value:

Time-saving in design and execution
Comprehensive approach
Capitalization of experience
Reproducibility of execution
Accessibility of data

More information:
Validatool

Technical Support

MICHENAUD François — 2007-11-15T16:34:35Z

The CVO-CyberConseil Group aims to strengthen management of our clients' projects and to provide immediately operational resources.

Our experts in technology adapt quickly to the client's environment and carry out missions in all fields of CVO-CyberConseil expertise.

Audits, Consulting and Training

MICHENAUD François — 2007-11-14T15:22:13Z

Audits
Our audit and assessment methodology enables us to perform quick and pertinent diagnostics and propose a relevant action plan, organized according to your priorities. Our independence is an assurance of neutrality and objectivity. Our auditing team is composed of highly experienced professionals having worked for over ten years in their areas of expertise and having acquired an international experience in Europe as well as in the USA.

Consulting
The consulting services of the CVO-CyberConseil Group are performed by well-qualified and experienced consultants. Our experts are thus able to assist you in change management for strategic projects with very high added value.

Training
The CVO-CyberConseil Group training centre has a twofold objective: meet our clients training needs and train our consultants, their qualification being a major requirement for our clients.

Different types of training are available:
intercompany training
intracompany training
customized training/action.

Facility Engineering and Process

MICHENAUD François — 2007-11-14T14:54:41Z

CVO-CyberConseil expertise enables us to intervene efficiently according to tested methodologies for:
Master plan, Preliminary Design and Feasibility study,
Requirements specification: requirements analysis, functional and value analysis, specifications,
Request for proposal, selection of solutions and service providers,
Documentation and reverse documentation: writing of functional and technical specifications,
Project management: planning and cost management, deadlines, resources,…
Change Management: training and communication tools,
Design and Conception Review,
Verification and release: physical Completion and inspection, Commissioning, Acceptance tests (FAT, SAT)
Business Continuity Plan, Disaster Recovery Plan.

Validation and Testing

MICHENAUD François — 2007-11-14T14:53:33Z

With its methodology based on risk and criticality analysis CVO-CyberConseil independently, efficiently and appropriately performs verification, testing and validation of your systems, software, processes, installations, equipments and facilities.
Our approach includes:
The validation methodology, organization, procedures, templates,
The global validation strategy, the Validation Master Plan,
The risk and criticality analysis, alignment of efforts on critical parameters,
Design Qualification (DQ), Enhanced Design Review (EDR),
Implementation and Installation Qualification (IQ),
Operational Qualification (OQ): verification of system operation through nominal, stress, limit and failure testing,
Performance Qualification (PQ): verification of system aptitude to function in a reproducible manner and of organization's capacity to control the system and achieve fixed objectives,
Writing qualification protocols and test forms, performing qualifications, assessing results and writing reports,
Gap, non-conformity, deviation and corrective action management.

Quality and Compliance

MICHENAUD François — 2007-11-14T14:53:11Z

Since many years CVO-CyberConseil has been specializing in regulation and standards applicable to the Healthcare industry as well as in Quality and Risk Management.

With the combined action of our experts and our regulation monitoring tool Validatool KR our team brings consulting and support to your regulation compliance projects in various areas:

Pharmaceutical Production and distribution (21CFR210-211 cGMP, GMP OCDE , GPD, …)
Laboratory Control (21CFR210-211 cGMP, GMP OCDE ,…)
R&D (21CFR58 GLP, BPL OCDE / GMP France,…)
Clinical (21 CFR 56, 21CFR 50, GCP, ICH E6, Directives 2001/20/CE,…)
Cosmetic (21 CFR 700, ISO 22716, GLP, GMP,…)
Chemicals (API) (GMP annexe 18, ICH Q7A, …)
Medical devices & IVD (, 21 CFR 8xx, directives 90/385, 93/42, 98/79, ISO 13485:2003, l'ISO 14971:2007.…)
Pharmacovigilance ( 45 CFR51 et 56, 21CFR50, 56, 312 et 314, ICHE2, BPP,…)
Chimical products and substances (Regulation CE 1907/2006, 1354/2007, REACH)
Information Systems (GAMP ISPE, PIC/S,ASTM2500, IEEE, 21CFR part 11, …)
Quality Management System and Audit (ICHQ10, ISO 9000:2000, ISO 19011:2002, ISO 100XX, …)
Risk Management (ISO 14971:2007, ICHQ9, AMDEC, HACCP,…)
Computing safety and quality ((IS012207, CMMI, ITIL, SPICE, ISO/CEI 270XX, EBIOS, MEHARI, …)
Security (guideline 94/9/CE, 1999/92/CE ATEX)
Finance (Sarbanes Oxley Act 2002) …

Quality Management System (QMS) / Audit / Documentation CVO-CyberConseil assists you in implementing, improving or updating your quality system in respect to regulation requirements and norms.

Our experts assist you during all phases of your Quality projects:
Definition of the Quality Policy, the organization to be implemented and the related responsibilities,
Implementation of a QMS complying to the GxP regulation and/or ISO standards.
Integration of ICH Q10 requirements for the pharmaceutical operations
Prototyping and evaluation of the processes and proposals for an improvement plan
Implementation of ICH Q9 Methodology of Quality Risk Management
Implementation and optimization of the documentation system
Creation or improvement of the Quality Handbook
Creation and update of procedures and work instructions
Internal and external audit (supplier, subcontractor, data center, integrator,...)
Proposal for corrective and preventive action plans
Simulation of an FDA inspection (mock audit)