US FDA To Conduct Inspections Focusing on 21 CFR 11 (Part 11) – CCS assessment services

FDA has announced (08-July-2010) that “The Agency (FDA) will be conducting a series of inspections in an effort to evaluate industry’s compliance and understanding of Part 11 in light of the enforcement discretion described in the August 2003 ‘Part 11, Electronic Records; Electronic Signatures — Scope and Application’ guidance (Guidance).”

It has been about seven years that US-FDA has debated 21 CFR Part 11 requirements and began using “Enforcement Discretion.”

FDA announced that: “The Agency expects to begin conducting the Part 11 focused inspections soon.”

Check now your 21 CFR Part 11 compliance status with our CCS services:

  • 21 CFR Part 11 assessment plans and checklists
  • Company Policy for electronic records and signatures 
  • Verification of your document management strategies and methodology (review, approvals, distribution)
  • Detailed and risk-based approach of production records, such as Master Batch Records, Calibration Records, Laboratory Records (refer to 21 CFR Part 211, Subpart J: records)
  • Validation status check of each relevant system including upgrades and up-to-date product White Papers
  • Training needs and Part 11 awareness  
  • Pre-Audit execution focused on 21 CFR Part 11

Contact right now talk@comes-compliance.com and get more information about our services dedicated to 21 CFR Part 11 compliance and inspection readiness.

By planning and verifying your 21 CFR Part 11 compliance concept, you will be better prepared to respond appropriately and efficiently to FDA auditors’ questions.

Open link to FDA announcement here.

New partnership with cr.appliance – closing gaps from pharma development to submission

comes compliance services  initiates a new business partnership with cr.appliance – visit http://www.cr-appliance.com/.

The partnership aims to offer consultancy for companies in the healthcare industry in the development and registration of drugs in early clinical development, including support and planning for biopharmaceutical development projects, providing additional external expertise during the submission and licensing process, and on life cycle management issues. 

Our customers will find the right solution and advice by combining each other’s expertise in study design, quality and validation requirements, and IT technologies.

Contact us for more information: talk@comes-compliance.com

Pharmaceutical Technology Europe, Jul 1, 2010: CCS Product Showcase

Read in the July issue of  the magazin Pharmaceutical Technology Europe (PTE) about the CCS eValidation concepts and solutions – Product Showcase.

Digital version: http://pharmtech.findpharma.com/pharmtech/issue/issueDetail.jsp?id=19117

Pharmaceutical Technology Europe (PTE) reports on developments in European pharmaceutical/biopharmaceutical development, manufacturing, and quality assurance and control. Providing technically focused peer-reviewed editorial, opinion, trends and analysis, PTE assists readers in their decision-making and implementation of best practice.

MS Sharepoint: GMP compliant document & quality management system

comes compliance services offers a new and GMP compliant Document and Quality Management System on the basis of MS Sharepoint. The product from the CCS Partner GxPi provides a well structured and unique document management platform including full audit trail, pre-defined document workflows, version and status control, electronic and digital signature technology, and additional compliance management modules. This 21 CFR Part 11 compliant system can be used for CAPA, OOS, deviation, investigation, and change control management. The MS look and feel makes the system easy to operate in a well known user interface.

Please contact us for more information or a  free web demo at: talk@comes-compliance.com

The one and only full GMP compliant DMS and QMS solution on MS Sharepoint.

 

News: BIOPRO Baden-Württemberg

Current Newsletters at BIOPRO:

Baden-Württemberg is the most innovative region in Europe. The figures for 2008 show that 4.2 percent of the gross domestic product is being invested in research and development. With its versatile, outstandingly efficient research in biotechnology and the life sciences, Baden-Württemberg has a unique trump card in terms of the economic development of the life sciences in the state.

CCS is located in the south of Germany, Ravensburg: More

The Biotech / Life Sciences Portal Baden-Württemberg is run by BIOPRO Baden-Württemberg GmbH.

CCS News: German ZLG Aide mémoire 07121105 “Inspektion von Qualifizierung und Validierung in pharmazeutischer Herstellung und Qualitätskontrolle”

CCS provides risk-based and compliant Validation and Qualification Services based on current regulations and standards. The German ZLG (central autority for helth protection) issed a new  Aide mémoire 07121105 “Inspektion von Qualifizierung und Validierung in pharmazeutischer Herstellung und Qualitätskontrolle”.

Read more here.

Contact CCS for more information: talk@comes-compliance.com

CCS using P3M3 project management for compliance projects

Portfolio, Programme and Project Management Maturity Model (P3M3) used in compliance project.

P3M3 uses a five-level maturity framework and the five Maturity Levels are:

Level 1 – awareness of process

Level 2 – repeatable process

Level 3 – defined process

Level 4 – managed process

Level 5 – optimized process

New US / Canada Business Partner

New CCS network partner in US / Canada:
RxGlobal Consulting Solutions Inc.;

 

Rx GLOBAL is an innovative life science consulting company that is rapidly increasing market share by providing competitive, common sense regulatory compliance consulting solutions for our client’s business challenges. Based in North America with Associate Partners in Europe and Asia, our team of seasoned, industry leading professionals provide the hands on expertise that will drive value throughout the full solution delivery lifecycle. Rx GLOBAL utilizes a flexible approach to define custom consulting solutions that exactly meet the project support needs and expectations of our international client base.

Our knowledge and expertise is rooted in successful compliance and validation project delivery, however, the vast experience of our consultants allow us to move past this core solution space into the definition and delivery of business process improvement and strategic corporate initiatives. For details on how Rx GLOBAL can assist your team in reducing project delivery timelines and costs, contact us at: information@rxglobalcs.com

Web: www.rxglobalcs.com

Read more at: http://www.rxglobalcs.com/partners.html