Information System Consulting
IT System Integration Management
As the world becomes ever more strongly globalized, it is not just multinational corporations that are confronted with the challenge that their business processes and IT systems need to be operated and monitored across countries, cultures and continents. Medium-sized companies, too, need to deal with the issue. Major corporations have a long tradition of doing so. For many medium-sized companies this is still relatively uncharted territory, even today.
As the world becomes ever more strongly globalized, it is not just multinational corporations that are confronted with the challenge that their business processes and IT systems need to be operated and monitored across countries, cultures and continents. Medium-sized companies, too, need to deal with the issue. Major corporations have a long tradition of doing so. For many medium-sized companies this is still relatively uncharted territory, even today.
CSV, 21 CFR Part 11
GAMP5 – Revolution or Evolution of CSV
Efficient Computer Systems Validation (CSV) and your risk is under control? GAMP5® takes up the topics “business validation” and “risk-based approach” and thus carries on GAMP4® consistently. Are you informed and up-to-date with your CSV methodology and documentation standards?
GAMP5 – Revolution or Evolution of CSV
Efficient Computer Systems Validation (CSV) and your risk is under control? GAMP5® takes up the topics “business validation” and “risk-based approach” and thus carries on GAMP4® consistently. Are you informed and up-to-date with your CSV methodology and documentation standards?
ERP/SAP Validation
“Validation is driving the costs up! … You cannot validate SAP®!” Even after more than 10 years of validation, these preconceptions have remained in the heads of operators and users of ERP systems. In this way much work was duplicated in the past or processed individually by the validation team. In addition, those responsible for IT often estimate that the expenditure for a manageable change management is very high.
“Validation is driving the costs up! … You cannot validate SAP®!” Even after more than 10 years of validation, these preconceptions have remained in the heads of operators and users of ERP systems. In this way much work was duplicated in the past or processed individually by the validation team. In addition, those responsible for IT often estimate that the expenditure for a manageable change management is very high.
Risk Management
Everyone is talking about the “risk-based approach”, and not just since GAMP 5. And rightly so: only if you know the risk associated with a computer-based system, you can set up and design validation and operations so that one does neither too much nor too little. Only with a clear view of the GxP risk is effective validation possible, targeted and restricted to the essential points.
Everyone is talking about the “risk-based approach”, and not just since GAMP 5. And rightly so: only if you know the risk associated with a computer-based system, you can set up and design validation and operations so that one does neither too much nor too little. Only with a clear view of the GxP risk is effective validation possible, targeted and restricted to the essential points.
Excel Validation
Quick and flexible calculations with Microsoft EXCEL® spreadsheets (ESS) are indispensable in analysis despite highly integrated LIMS and QM systems. Not rarely there are “umpteen” different applications being used at the same time – from simple, stand-alone systems that have been developed internally to purchased, networked and macro-based programming. Often an overview is lacking, as are risk assessment and validation.
Quick and flexible calculations with Microsoft EXCEL® spreadsheets (ESS) are indispensable in analysis despite highly integrated LIMS and QM systems. Not rarely there are “umpteen” different applications being used at the same time – from simple, stand-alone systems that have been developed internally to purchased, networked and macro-based programming. Often an overview is lacking, as are risk assessment and validation.
Infrastructure Qualification
When the topic “IT infrastructure qualification” was first broadly discussed a few years ago, there was great excitement. People talked a lot about it, but besides initiating a few pilot projects, did not do much. After that, all was quiet about IT infrastructure qualification for a long time – but by now, the topic has arrived in practice.
When the topic “IT infrastructure qualification” was first broadly discussed a few years ago, there was great excitement. People talked a lot about it, but besides initiating a few pilot projects, did not do much. After that, all was quiet about IT infrastructure qualification for a long time – but by now, the topic has arrived in practice.
Laboratory Equipment Validation
These days, Analytical Instrument Qualification (AIQ) and Computerized Systems Validation (CSV) are everyday processes in a GMP laboratory. USP General Chapter <1058> and GAMP 5® open up new possibilities to validation and/or qualification. Are you informed and up-to-date with your methodology and documentation standards?
These days, Analytical Instrument Qualification (AIQ) and Computerized Systems Validation (CSV) are everyday processes in a GMP laboratory. USP General Chapter <1058> and GAMP 5® open up new possibilities to validation and/or qualification. Are you informed and up-to-date with your methodology and documentation standards?
cGMP-ITIL -SOX Harmonization
Product safety, process security, safety of business operations – how else can one describe in words the requirements derived from CSV/GMP and ITIL/Cobit or EuroSOX (SOX) compliance. A regulated company’s IT department is exposed to requirements from the most varied sides for safety of operation, data security, process security, ensuring business operations, etc. How can one integrate these things in corporate IT governance?
Product safety, process security, safety of business operations – how else can one describe in words the requirements derived from CSV/GMP and ITIL/Cobit or EuroSOX (SOX) compliance. A regulated company’s IT department is exposed to requirements from the most varied sides for safety of operation, data security, process security, ensuring business operations, etc. How can one integrate these things in corporate IT governance?