CCS at the BIOTECHNICA 2010

source: BioLago e.V.

comes compliance services (CCS), exhibitor at the BIOTECHNICA in Hannover/Germany, presented compliance management solutions to visitors at our event booth. Pharma 2.0 approaches and solutions, IT validation management, Audit Management Services, and regulatory compliance integration offered and delivered by CCS were clearly represented. Mrs. Schmid from CCS said: “A lot of visitors were asking about modern and smart solutions, as we have it in our CCS compliance programs”. Together with the BioLago team, CCS was able to show holistic innovation strategies that enable our customers to fulfill regulatory requirements and come up to the challenges of today’s business.    

More than 9,500 visitors from 40 different nations attended BIOTECHNICA to find out about the latest biotechnology trends in the fields of healthcare, food production, industry, environmental protection, lab equipment and bioinformatics – as well as to transact new business deals (source: BIOTECHNICA – visit www.biotechnica.com).

MS Excel Spreadsheet Validation – New Focused Solution Packages (FSP) by CCS

CCS introduces its new Focused Solution Package for MS Excel Validation. This fixed price offer contains a full package for covering the validation of spreadsheets and rapid integration on customer sites:

  • SOP template: Validation of MS Excel
  • SOP template: Design and creation of MS Excel Spreadsheets including Best Practice Guide (Design)
  • MS Excel Validation Master Plan and Inventory List
  • MS Excel Templates – simple and complexe design – including Best Practice functions and add-ons
  • Validation Plan and Test templates
  • Optional: Online Tracking Tool / Password Repository
  • Optional: Training and 2 days implementation consultancy

By implementing this entire Focus Solution Package our customers can have compliant Spreadsheets in less than 20 days.

Contact us today at: talk@comes-compliance.com

ERP SAP ECC 6.0 meets ISPE GAMP 5 validation approach

At comes compliance services a new validation approach was designed for an efficient validation execution of the ERP SAP ECC 6.0. By integrating the SAP Best Practices for Healthcare including the building block methodology we can offer this special and pre-defined validation workflow to support the validation execution. Especially the ERP version upgrading process and data migration validation is covered by different tools and methods. We use the Best Practice approach together with the applicable release notes and migration analysis, e.g. customized code detection, data classification analysis, site impact analysis, and test plans for regression or automated testing.

This approach assures a full risk-based validation process according ISPE GAMP 5 in any ERP project.

Contact now our ERP validation experts at: talk@comes-compliance.com and ask us for more details of ERP SAP ECC 6.0 validation projects.

Audit Service Center Upgraded at www.auditservicecenter.com

comes compliance services (CCS) has upgraded its audit management services on a seperate domain: www.auditservicecenter.com

The new web site contains an entire overview of the audit management and related tools, which are totally integrated in the process work flows provided by CCS.

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 compliance projects ensure that supply chain requirements meet quality management support, be it for finding a second source of material or component supply, collaborating with suppliers on quality aspects, or investigating suitable outsourcing options. We create the “vendor to partner” dynamics required for improving products and reducing deficiencies.   

Visit now:  www.auditservicecenter.com to get more information and news about audit and CAPA management, supplier chain optimization, shared audits, and other compliance service options.

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.