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

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 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.

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 talk@comes-compliance.com.

FDA issued a brand-new Draft Guidance for Industry, Third Parties and FDA Staff: Medical Device ISO 13485:2003 Voluntary Audit Report Submission Program: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

New ISPE GAMP Good Practice Guide: MES - Manufacturing Execution Systems

The Guide uses a complete lifecycle approach to the development and use of MES for regulated manufacturing as a collection or domain of manufacturing related functions that integrates business and process controls, information flow, and human interaction to facilitate the operation of an organization. It collects and integrates information and knowledge from many disciplines and sources into a single comprehensive guideline.

http://www2.ispe.org/eseries/scriptcontent/orders/ProductDetail.cfm?pc=GGPGMESUS

Find here subject matter experts for ISPE GAMP 5 MES operational governance and consultancy: www.comes-compliance.com 

New ISPE GAMP Good Practice Guide: A Risk-Based Approach to Operation of GxP Computerized Systems - A Companion Volume to GAMP 5

During the operational life of a GxP system regulators usually focus on the integrity, consistency, and completeness of controls required to maintain compliance. This Guide highlights the importance of the operation phase of the system lifecycle, when the return on investment for the significant time and resource expended in implementing new computerized systems can be achieved. The Guide will help regulated organizations achieve regulated computerized systems that are fit for intended use and compliant with applicable regulations and provides comprehensive guidance for maintaining control of regulated systems throughout their operational life.

Read here the Table of Contents of the GPG.

Listen now to a FDA broadcast - computer systems used in medical device clinical investigations.

Open this link here.