I WANT THE RIGHT HAND SIDE COLUMN FILLED WITH CERTAIN EXAMPLES OF THE SYSTEMS MENTIONED BELOW ,ANY ONE WHO HAS EXPERIENCE ON WORKING ON COMPUTER SYSTEM VALIDATION IN GAMP environement can do this ,should have knowledge of 21 cfr part 11
the systems i would like to take as an example are
• Clinical Trial Management Systems: Oracle Clinical, IMPACT,CDMS
• Desktop Applications: Excel spreadsheets, Access databases, SharePoint sites
• Digital Signature: DocuSign, AdobeSign
• Document Management Systems: Documentum, SharePoint, Veeva
• Electronic Data Capture (EDC): Medidata products
• Enterprise Requirements Planning Systems: SAP
• Labeling and Inspection Software: Calypso, MeasureMind, Docu-Proof
• Laboratory Instrument Software: Empower, NuGenesis, ChemStation, Quadstar
• Laboratory Information Management Systems: STARLIMS, Applied Biosystems, Thermo
• Learning Management Systems: ISOtrain, Active Learner, IQS
• Manufacturing Execution Systems: Delta V
• Pharmacovigilance Systems: PV Works, PV analyser ,PV dashboards
• Quality Management Systems: TrackWise, IQS Quality Management, EtQ
• Validation Management Systems: HP ALM
Dear Sir,
I have read your job and I can provide you with the skills you require. I use to work to time lines and meeting clients' expectations with prompt communication.
I have got more than 8 years of experience working with SharePoint.
Some of the clients I recently worked for are:
1. Arriva Group
2. Adidas Group
3. Associated Foreign Exchange
4. iJento
5. Red 7 Marine
6. Retail Space Design
7. Housing Solutions
Should my proposal be of interest to you please do not hesitate to contact me to discuss this further.
Kind Regards,
Nihar Shah.
Hello! I have been working more than 10 years in computerized systems validation at various international pharma companies. There are a few things that you should know about this list for example when talking about Quality Management Systems this also includes Document Management, Digital Signatures, Learning Management as these are critical quality management processes. Most software packages can be used for different purposes e.g. a company I worked for used SAP for document management. If a software package contains features for part 11 compliance it should also include digital signatures. There are almost as many laboratory instrument software packages as there are types and models of laboratory instruments. It will take about a day to list up all the software I know about which are used in the industry.
I'm eager to learn more about your challenges in order to help you achieve part 11 compliance. My rates are negotiable depending on the effort and duration of the project. Best Regards!