comes compliance services - IT Pharma Validation

+++ PDA Parenterals 2010, Berlin sponsored by CCS +++ New Audit Services provided to industry +++ FDA To Conduct Inspections Focusing on 21 CFR 11 (Part 11) requirements relating to human drugs +++ Medical Devices QMS: ISO 13485 and FDA requirements +++ Chinese ISPE GAMP 5 Version +++ Germany's BfArM moves to nearly paperless submissions (eCTD) +++ New GAMP publication: GAMP Good Practice Guide: MES +++ New GAMP publication: GAMP Good Practice Guide: A Risk-Based Approach to Operation +++ Computer Validation - FDA expectations and requirements +++ ICH Q10 - Quality Systems guideline +++ Financial crisis and global health +++ New: ISPE Good Practice Guide: Maintenance +++ ICH Q8/Q9/Q10 - Questions & Answers +++ ISPE Pharmaceutical Engineering Publication - March April 2009 +++ ISPE Good Practice Guide: Good Engineering Practice published +++ ICH: Contact the Quality IWG with your comment and questions concerning Q8-Q9-Q10 +++ PIC/S: REVISION OF PIC/S GMP GUIDE +++ EMEA: Eudralex Version 19 December 2008 +++ 21 CFR Part 11: current status (2008) +++ GAMP 5 and PRODUCT QUALITY LIFECYCLE IMPLEMENTATION (PQLI) +++ FDA Warning Letters 2008 (computer system validation) +++ ICH Q10: PHARMACEUTICAL QUALITY SYSTEM - Step 4 +++ CMMI - Capability Maturity Model Integration (GAMP 5) for development +++ Computer System Validation in the area of GCP +++ ISPE NEW BASELINE® GUIDE: Risk-MAPP +++ PFQ magazine: E-signature article published by IT Pharma Validation members +++ EMEA: Public consultation on revisions of GMP Annex 11 on Computerized Systems +++ FDA: 21 CFR Parts 210 and 211 ACTION: Direct final rule; withdrawal +++ FDA Acronyms and Abbreviations Database +++ GAMP 5 and ISO 12207 +++

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PDA Parenterals 2010, Berlin sponsored by CCS

Saturday, 21 August 2010 09:07

The PDA event Parenterals 2010: Integrating Process, Technology and Regulation in Berlin is sponsored by CCS. Event details: OPEN

New Audit Services provided to industry

Thursday, 12 August 2010 00:11

The Audit Service Center (ASC) is providing new services to the pharmaceutical and life science industries.

Visit now: www.auditservicecenter.com

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.

FDA To Conduct Inspections Focusing on 21 CFR 11 (Part 11) requirements relating to human drugs

Friday, 09 July 2010 00:00

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!

Open link to FDA announcement here.

Book of Validation - Download current regulations and templates

Monday, 14 June 2010 10:47

We have re-designed our download area for registered members. Now you have an up-to-date "book of validation" - with current regulations, standards, and templates.

Visit: http://www.ccs-inspired.com/downloads

We also offer to you a company and industry specific online library, regular updating services and GxP trainings. If you want to get more details about our services, contact This e-mail address is being protected from spambots. You need JavaScript enabled to view it .

Medical Devices QMS: ISO 13485 and FDA requirements

Tuesday, 25 May 2010 21:06

FDA issued a brand-new Draft Guidance for Industry, Third Parties and FDA Staff: Medical Device ISO 13485:2003 Voluntary Audit Report Submission Program:

Read here HTML.

Read here PDF.