Technology Solutions
SmartAdvance™ Solutions
SmartAdvance Solutions are probably the most robust, simply designed, fully integrated, cost efficient and compliant to 21 CFR Part 11, enterprise operation management tool in the market.
SmartAdvance™ Solutions are based on the Integral-Nodes methodology and information technology. The SmartAdvance™ Solution is a powerful and simple batch information management system. It is an integrated suite of modules that includes computer-integrated batch documentation.
SmartAdvance™ Solutions model, control and track all aspects of production on the plant floor, while providing a detailed and complete history for compliance and performance improvements. SmartAdvance™ Solutions has four main components : SmartAnalysis™, SmartControl™, SmartReport™ and SmartStat™.
Business Benefits of SmartAdvance™ Solutions
The advantages of SmartAdvance™ Solutions can be grouped into two categories: operational efficiency and compliance improvements. Some of these significant, business-related benefits possible for pharmaceutical manufacturers that use SmartAdvance™ Solutions include:
- Reduced cycle times
Reductions in the physical passing of records between departments will lead to an overall reduction in the time needed to produce and ship product.
- Improved accuracy and consistency of batch record
The information content management structure provided SmartAdvance™ Solutions will decrease errors, which in turn will decrease the time spent by quality assurance in the review of these records.
- Reduced costs of compliance
Automation of quality assurance functions such as the generation of qualification test scripts and reporting features built into the Nodes Suite information technology will decrease the effort required to research product deviations.
- Increased productivity
Electronic exchange of batch records decreases the amount of time spent collecting the various components of the batch record from different departments.
- Cost avoidance
Batch records must be retained for at least one year after the expiration of drug product. Use of SmartAdvance™ Solutions can eliminate the need to allocate resources to the storage and retrieval of archived batch records.
- Increased speed of product changes and product introductions
Use of SmartAdvance™ Solutions during drug development process will lead to greater efficiencies in a New Drug Application.
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