Information Technology Summary
IT Challenges
Your IT department has been challenged by management to implement software automation that increases productivity in the labs while cutting costs and maintaining regulatory compliance. You also have to create and maintain an integrated infrastructure to allow reuse of that data for corporate decision making. If you can do all that, will everyone be happy?
 Not necessarily. Some groups may be threatened by the changes that automation brings about. Others are resistant to the loss of familiar tools and processes. This may put the users at odds with management and your IT group.
Once you clear those hurdles, you need to ensure that any new technology will mesh with current IT investments. The technology must be quickly deployed and validated to ensure the business units aren’t significantly impacted in a negative way. With aggressive timelines and budget restrictions, the challenge can be daunting.
A Purpose-Built Solution
VelQuest can help you answer the challenge with the SmartLab GMP Electronic Notebook System. It is a proven purpose-built pharmaceutical industry solution that mimics the paper-based processes that lab analysts are used to working with, but offers all the advantages of computer driven automation such as:
- Secure access to approved files and systems on your network
- Reliable data capture from PC and RS-232 lab instruments
- Data exchange with other IT systems (LIMS, EDMS, ERP, CDS)
- Sensible organization and search of data in the event of an audit
- Technical controls for Part 11 compliance
- Built on industry standard tools
Because SmartLab is a configurable COTS system, and doesn’t require complex customization at the code level, the demand for FTE’s to maintain the system is much less than you’d find with other lab technologies like LIMS. It’s also designed to be configured and maintained by the business unit that owns it, making life simpler for IT. The system runs on industry standard tools such as Microsoft Windows, Citrix, and Oracle. Once configured, it can be scaled to the rest of the organization.
VelQuest can work with all members of your team, from executive management and IT to validation and QA/QC groups, to assess your lab workflow and processes. We’ll identify areas that can improve through use of automated cGMP ELN solutions, and the metrics you can expect. Full short term and long term cost projections (FTE resources, hardware, software, validation, maintenance, and training) and financials (IRR, ROI, NPV) are made available, allowing you to go to management with confidence in the automation you’ll propose.
To learn more about this purpose-built off-the-shelf GMP electronic notebook system, click here
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