Article published on Pharmaceutical Technology Europe – New Annex 11: Enabling Innovation –
Read it online here.
EU GMP Annex 11 in French language can be downloaded here. (thanks to Mr. Yves Samson)
Update (July 2013) on Aide Mémoire 07121202 der ZLG: Überwachung computergestützter Systeme (Annex 11 / Anhang 11)
Read the CCS brochure online:
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How systems can support compliance in a regulated environment:
The webinar will consider the evolution in the development and delivery of compliance related document management systems using the challenges of managing Quality Management System (QMS) documents. It will look at the advantages of using documents in a SharePoint environment for working examples.
Over the last decade, the requirements of organisations around the implementation of compliance related systems have evolved, which has significantly changed the relationship between the people, process and technology.
The tendency now in the experienced organisations (those where EDM is in its 2nd or 3rd generation) is to implement a configurable platform, providing a set of functionality to support the users but not to make the system wholly responsible but operate in conjunction with the working processes and the decisions made by the users themselves. This change can be loosely described as a rebalancing of the people-process-technology triangle, which is often used to describe the implementation of systems.
This evolution has resulted in advantages in terms of usability, acceptability and reduced total cost of ownership in ensuring GxP compliance. READ MORE
23 March 2011 at 15:00 GMT
contact: atoepsch@gxpi.de
EMA published today the new GMP Annex 11 – Computerised Systems – revision January 2011 – download your copy here: PDF
The deadline for coming into operation of the new Annex 11 is 30th June 2011.
Basic Principle of the new Annex 11 (Ref.: annex11_01-2011_en):
This annex applies to all forms of computerised systems used as part of a GMP regulated activities. A computerised system is a set of software and hardware components which together fulfill certain functionalities.
The application should be validated; IT infrastructure should be qualified.
Where a computerised system replaces a manual operation, there should be no resultant decrease in product quality, process control or quality assurance. There should be no increase in the overall risk of the process.
Contact now CCS for the new Annex 11 implementation package for efficient and compliant integration: talk@comes-compliance.com
GxPi Ltd. is the UK partner of comes compliance services, providing excellent services and products to our customers. Find below current GxPi case studies and white papers:
Contact us today for more information or a product presentation: talk@comes-compliance.com
comes compliance services is looking back to a very successful year 2010. CCS successfully increased revenues as well as hired a number of new professionals to further strengthen the compliance management teams. A number of local and global compliance projects were successfully finished, e.g. FDA audit preparations, eValidation implementation, Quality Management integration, Corrective Action planning and management, FDA independent review tasks, IT system validation, MES, BMS, and SCADA projects.
In 2011 several projects will be executed by CCS including HP Quality Center integration as eValidation tool, a full compliance tracking team on customer site, new ERP andMES validation projects, new quality plan integrations and corresponding remediation plans.
Three new team members will join CCS in January 2011, followed by several other experts and professionals for the regulated industry and more than 20 days of public trainings are already planned for several topics.
when it comes to compliance….
CCS was giving a lecture at the Hochschule Albstadt Sigmaringen (University – pharmaceutical Technology). Mr. Markus Roemer was giving to the students an overview of different aspects of Pharma 2.0 methods and current industry thinking & approaches.
The implementation of electronic systems, which are using electronic signatures, e.g. for batch recording, lab management, eCTD, and document management systems, require a well balanced approach of implementation and validation.
comes compliance services was sponsoring the PDA Event:
PDA Europe Conference – Parenterals 2010 – Integrating Process, Technology and Regulation, 26-28 October 2010 in Berlin, Germany.
The visitors’ feedback of the conference was very positive – excellent speakers, good speach topics, well organized, opportunity to exchange information and ideas.
Feel free to contact us today at talk@comes-compliance.com for more information and our CCS solutions.
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).
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:
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
