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GMP-Compliance bei IT-Projekten

IT Validation Matter Expert in German language – 17. to 18. June 2013 in Freiburg, Germany.

—————– in German ————————–

IT-Projekte ziehen sich von der Bedarfsmeldung bis zur Implementierung oft über Jahre hinweg, sind kostenintensiv, in hohem Maße interdisziplinär und oft ganz oder in Teilen GMP-relevant. Durch diese Kombination kommen IT-Projekte ganz automatisch an der einen oder anderen Stelle ins Stocken, es kommen unerwartete Fragen auf, die einen neuen Fahrplan für das Projekt bedingen. Dabei spielt es keine Rolle, ob es sich um ein ERP, EBR, ein MES oder irgendein anderes Projekt zur elektronischen Dokumentation oder Steuerung von Prozessen handelt. Die Leiter und Hauptverantwortlichen eines IT-Projektes brauchen Geduld und Ausdauer und gute Partner an ihrer Seite.

An diesem Tag stehen Sie mit Ihren Fragen und Problemen im Mittelpunkt. Profitieren Sie von den Tipps der Experten und den Erfahrungen der anderen Teilnehmer – hier liegt ein immenses Potential, um Fehler zu vermeiden und Wege aus festgefahrenen Situationen zu finden. Nutzen Sie diese große Chance zur Kosteneinsparung und Optimierung Ihres IT-Projektes!

Programm
Wir besprechen genau die Themen, die Ihnen persönlich auf den Nägeln brennen! Teilen Sie uns dazu im Vorfeld Ihre Fragen mit.

Mögliche Schwerpunkte sind:
– Wir stehen am Beginn eines IT-Projektes. Wie müssen die Weichen gestellt werden, damit das Projekt ohne große Verzögerungen abläuft?
– Welche Parteien müssen mit im Boot sitzen und wie sollten die Verantwortlichkeiten verteilt werden?
– Was ist zu beachten, wenn Programme von Mutterhäusern oder aus dem Konzernverband übernommen werden sollen?
– Wie erreichen wir ein optimales Design, das alle wichtigen und nicht zu viele Funktionalitäten erfüllt?
– Ist erforderlichenfalls eine funktionierende Audit-Trail Funktion vorgesehen?
– Wie finde ich den richtigen Lieferanten? Welche Leistungen können / sollten im Hause erbracht werden und welche nicht? Was ist Bestandteil des Quality Agreements?
– Wann fällt das Projekt in Teilen oder vollem Umfang unter die Validierungsanforderungen (Systemklassifizierung)?
– Sind die regulatorischen Anforderungen nach Annex 11 erfüllt?
– Welche Stolpersteine können bei der Implementierung auftreten und wie gelingt eine reibungslose Einführung und Umstellung?
– Was ist bei der Planung der Datenmigration beachten?
– Was ist bei Abschaltung des Altsystems zu beachten?

Read more

Or contact us at talk@comes-services.com for more details.

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New GAMP® Good Practice Guide: Testing

ISPE issued the second edition of the GAMP® Practice Guide: A Risk-Based Approach to Testing of GxP Systems. This Guide helps the reader to maximize testing efficiency without compromising the quality of GxP Systems by focusing testing on areas that have the greatest impact and eliminating duplicate testing. This GAMP® Good Practice Guide has been recently expanded and updated to conform to GAMP® 5 standards and terminology.

Read more

 

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Berater (Freelancer) gesucht – Ihr PLUS an Beratung im CCS Netzwerk

Sie sind ein selbstständiger Berater oder Freelancer im GxP – regulierten Bereich oder haben die Absicht sich selbstständig zu machen? Gemeinsam mit anderen professionellen Mitgliedern in einem renommierten Netzwerk sind verschiedene Vorteile für Sie umsetzbar.

Lesen Sie mehr in unserer Broschüre: Freelancer für CCS broschüre

Kontaktieren Sie uns via Email – freelancer@comes-services.com.

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Global Harmonization Task Force (GHTF) moved to IMDRF

The Global Harmonization Task Force (GHTF) website is no longer operational at http://www.ghtf.org/.

The site was moved to the International Medical Device Regulators Forum at http://www.imdrf.org/. The archived documents can be found at: http://www.imdrf.org/ghtf/ghtf-archived-docs.asp

The International Medical Device Regulators Forum (IMDRF) was conceived in February 2011 as a forum to discuss future directions in medical device regulatory harmonization.

It is a voluntary group of medical device regulators from around the world who have come together to build on the strong foundational work of the Global Harmonization Task Force on Medical Devices (GHTF), and to accelerate international medical device regulatory harmonization and convergence.

 

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Rules and Guidelines in 2013 for Computer System Validation

Annex 11 (“Computerised Systems”) and Chapter 4 of January 2011 have been revised in response to the increasing use of electronic documents within the GMP environment by the EMA (European Medicines Agency). Two years later (January 2013) we would like to reflect the current status of the implementation at some agencies and the pharmaceutical industry.

Download the article here: Computer System Validation 2013

If you have questions or comments, please contact us at talk@comes-services.com.

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EudraLex – Volume 4 GMP – Chapter 1 – Pharmaceutical Quality System – revision 3 and Chapter 7 – Outsourced Activities

EMA published revision 3 of GMP Chapter 1 and renamed it to “Pharmaceutical Quality Systems”, as refered to ICH Q10, and Chapter 7 “Outsourced Activities”.

The deadline for coming into operation of both chapters is 31 January 2013.

Contact us today for more information or on how to integrate PQS and QRM at: talk@comes-services.com

Further reading: Current interpretation of Chapter 7 to Annex 11 requirements – Read it online

 
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A Pragmatic Approach and Solution for Spreadsheet Validation – BSP Solution

Within the GxP-regulated environment every firm is using spreadsheets in its daily use. Some are used on an ad-hoc basis for simple calculations or verifications; some are used for calculating quality-decision or product relevant data, which may be used for batch certifications or other quality records and reports.

In any case the design, usage and management of spreadsheets should follow a risk-based validation approach. Very often the MS Office application “MS Excel” is used for spreadsheet calculations, but also other (similar) or open-source software may be used.

The ISPE GAMP 5 standard does provide one single chapter in a special topics area for the special “system” type of “IT applications” – this is more or less described on one page of the entire guidance document. To understand the expectations of an inspector it might be useful to reference to the Draft version of the EU EudraLex Vol. 4 – Annex 11 – Computerised Systems ref. Section 3.8. Also this section was not taken over to the final version of Annex 11 (Revision 2011), it is showing the challenges and the expectations from a regulatory point of view.

 Source: Annex 11 Draft Version – February 2008

3.8  Spreadsheets should be suitably checked for accuracy and reliability and stored in a manner which ensures the appropriate version control. The calculations should be secured in such a way that formulations are not intentionally or accidentally overwritten. The calculations should be executed with precision displayed on the screen or in reports. Formulations should also be protected from accidental input of in appropriate data type (e.g. text in a numeric field and or a decimal format into integer field).

One of the major hurdles in validating spreadsheets is that these are normally purely file-based and stored on a more or less secured file server location on the basis of the operating system. The above mentioned “appropriate version control” of files and requirements for avoiding the “overwriting” of them seems to be insolvable if not transferred to a better (unique) platform.

Therefore CCS has developed together with the solution partner “ott+partner” – http://www.ott-partner.com/ a basic spreadsheet platform (BSP Solution), which is enabling pharmaceutical companies to use validated spreadsheets in their daily business cases and executions.

Our BSP solution is based on the fundamental architecture and principles of database objects and can be totally integrated in any customer system landscape, if required to already implemented solutions like ERP systems, LIMS, or Document Management Systems (e.g. on the basis of MS SharePoint). In any case the BSP solution will be the secured and central point for all spreadsheet applications and do fulfil the technical and procedural requirements to the best practice principles for a risk-based validation. In addition features like electronic signatures or dedicated approval workflows can be implemented and spreadsheets are easy to use and to validate.

 Contact us today for more information or an online demo at: talk@comes-services.com

 

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Partnership Announcement Phamedics and CCS

 Durham NC / Ravensburg, Germany , September 14th, 2012

Phamedics Consulting is delighted to announce a strategic consulting partnership with comes compliance services. comes compliance services is a European based, highly experienced, boutique consulting company specializing in simplifying and streamlining EMA, FDA, ICH, GHTF quality systems, and fulfilling validation and regulatory compliance requirements.

This partnership will allow comes compliance services to continue to expand its excellent compliance services by utilizing Phamedics Consulting as partner to provide Quality & Compliance services throughout the United States especially to the Triangle region of North Carolina, the South East Pharma and Biotech corridor of the US.

The two firms compliment one another`s quality and compliance service offerings and will work together to provide clients with excellent services in cGMP compliance, Project Management, Quality Systems Improvement and Validation. 

 

About Phamedics Consulting

Phamedics Consulting is a project consulting firm focused on supporting the pharmaceutical, biotechnology, medical devices, food & beverages, clinical research, cosmetics, consumer products and other FDA regulated industries solve the complex challenges and decisions facing their company today. Phamedics Consulting offer Quality & Compliance solutions and project management consultant services to a diverse range of regulated industry clients. Please visit our website to learn more about services at www.phamedics.com

About comes compliance services

comes compliance services is a European based, highly experienced, boutique consulting company specializing in simplifying and streamlining EMA, FDA, ICH, GHTF quality systems, and fulfilling validation and regulatory compliance requirements. At comes compliance services (CCS), we strongly believe that quality and compliance management will drive continuous improvement and performance optimization. We utilize a more proactive and risk-based approach to quality assurance and validation backed by proven expertise and electronic tools from our partners. We focus on value-added project, process and risk management to achieve regulatory compliance and inspection readiness. The following services and products are available to GMP, GLP, GCP and medical device regulated companies and suppliers:

  • Quality Management Services
  • IT Project Management Services
  • Comprehensive and risk-based validation concepts and services
  • Validation Tools for Requirements, Project, and Test Management

We invite you to explore our website and learn more about our capabilities, spectrum of services, contact information, and much more at www.comes-compliance.com and www.auditservicecenter.com .