ISPE Good Practice Guide for Project Management – RACI Chart example 

ISPE offers a free pre-view for RACI roles / RACI Chart used in the pharmaceutical industry within a Project Delivery Plan (PDP): ISPE Good Practice Guide for Project Management – RACI Chart example Read more (GMP datability projects)    

Part 11 and Annex 11 – Commonality Analysis for the number 11 

It seems that the number 11 is prereserved to computerized system topics in the GMP regulated industry. Beside of EU EudraLex Vol.4 Annex 11 and 21 CFR Part 11 the PIC/S guideline for computerized systems hold this number (PI 011) or the German Expert Inspector Group with EFG 11. What is it about the number […]

FDA Guidance for Industry / Draft: Management of Cybersecurity in MEDDEV 

  This guidance has been developed by the FDA to assist industry by identifying issues related to cybersecurity that manufacturers should consider in preparing premarket submissions formedical devices. Read more: Guidance For Industry: Management of Cybersecurity Contact us:

Computervalidierung: Grundlagen, Regeln, GAMP 5, 18.-19. November 2014 in Baden-Baden 

Special: Sondertraining wegen großer Nachfrage Am 18. und 19. November bieten wir nochmals ein Sondertraining zur Computersystemvalidierung in Baden-Baden an. Dieses Training beinhaltet ferner weitere Themen und Aspekte zur Computersystemvalidierung, z.B.: Was versteht die US-FDA unter “exact/true copy” einer elektronischen Aufzeichnung? Datenintegrität: Was sind Rohdaten, Meta-Daten, Stammdaten oder Audit Trail Daten? Ausführliche Darstellung des ZLG […]

BioLAGO-Projekt eArchiving – Daten sicher und dauerhaft speichern 

Am 29. Juli 2014 fand der erste Workshop in Konstanz statt. Im Vordergrund des Workshops standen Themen wie: Ablage von Daten (Kundendaten/Mess- und Labordaten), Datenaustausch (u.a. mit Geschäftskunden), Zugriffsregelung, Sicherheit, GxP-Konformität, Analyse auf historischen Daten oder Rohdatenmanagement. “eArchiving” wird gefördert durch die landesweite Initiative “smart businessIT: Die IT stärken. Das Land vernetzen”. Diese zielt darauf ab, […]

MHRA – Guidance on medical device stand-alone software (including apps) 

The MHRA (Medicines and Healthcare Products Regulatory) has published a guidance on medical device stand-alone software (including apps) in March 2014. The following guidance is for healthcare and medical software developers who are unsure of the regulatory requirements for CE marking stand-alone software as a medical device. Read it online here: OPEN EXTERNAL LINK Read […]

FDA – Q&A on cGMP – Records and Report from August 26, 2013 

Question #3 of the Q&A section: How do the Part 11 regulations and “predicate rule requirements” (in 21 CFR Part 211) apply to the electronic records created by computerized laboratory systems and the associated printed chromatograms that are used in drug manufacturing and testing? Some in industry misinterpret the following text from “The Guidance for Industry – Part […]

Training: Experte für Dokumentation am 11.-13.11.2014 in Niederkassel bei Köln 

    EU GMP Kapitel 4 – Dokumentation – Rohdaten und elektronische Dokumentation richtig bewerten und verwalten: Wie sind GMP Dokumentationsanforderungen und Gute Dokumentationspraxis in elektronischen Systemen darstellbar? Was sind Vorgabe- und Nachweisdokumente und was davon Rohdaten oder Metadaten? Wie verhält es sich mit Signaturen, wenn das Masterdokument elektronisch definiert ist? Wie sind konforme Ausdrucke […]

CCS Solutions: Technology Partner Novatek 

Partnership Announcement Novatek and CCS Montreal, Canada / Ravensburg, Germany, April 11th, 2014 Novatek is delighted to announce a strategic partnership with comes compliance services (CCS). comes compliance services is a European based, highly experienced consulting company specializing in simplifying and streamlining EMA, FDA, ICH, GHTF quality systems, and fulfilling validation and regulatory compliance requirements. […]

EMA: Guideline on process validation for finished products 

The EMA has published the “Guideline on process validation for finished products – information and data to be provided in regulatory submissions”. This Guideline will come into effect on 15. July 2014. This guideline replaces the previous note for guidance on process validation (CPMP/QWP/848/96, EMEA/CVMP/598/99). The guideline is brought into line with ICH Q8, Q9 […]