LIMS

SPECTRUM*LIMS is a comprehensive 21 CFR Part 11 compliant software solution that is used to monitor the critical quality attributes in a manufacturing environment. While streamlining the process, it also ensures that the internal and external regulatory compliance parameters are met. The system takes into account the finer elements that are peculiar to any manufacturing operation.

Major benefits of a typical implementation include compliance with internal SOPs and external regulations, single and central database, precise, accurate, relevant and timely information to take decisions for all levels. The results after a successful implementation can be summarized as Cost efficiencies, Quality improvements, Resource optimization, implementation of corporate and regulatory controls etc.

The scope of the software cover various sections such as Raw material, Packaging material, In process, Semi finished, Finished, Competitor product, R&D, Environment etc.

Can independently cater to the requirement of each functional area like physical lab, chemical lab, microbiological lab, and work list assignments etc.

Statistical analysis with SPC tools and charts help diagnose the root cause of the problem and the weak performing areas for process optimization. These tools include Trend Analysis, x-chart, x bar chart, s-chart, Pareto diagram and histogram. System also provides six-sigma monitoring.

The flexibility of the software helps define complex testing formulae and sequence into the system. Once these parameters are defined system ensures that the prescribed procedures are followed and batches/samples are only approved when the results are within approved specifications. In case of an unsatisfactory test result, system has the built-in intelligence to guide the user what retesting requirements are to be followed.

Functions & Features

• Caters any number of section/product/material
• Each section works independently
• Any number & type of tests like Appearance, Color, pH, Viscosity, Content uniformity, Dissolution and etc.
• User defined formulae for result calculation
• Test result passing limits
• Control limits for A-typical results
• User defined number of readings of raw data
• User defined number of decimal places for test results
• Retest (Revalidation) specifications
• Sample login
• Work list assignments
• Online/Manual data acquisition
• Repeat test results
• Decision on batch/sample
• Time consumed on testing of a batch/sample
• Retest (Revalidation)
• Investigation on samples
• Retest (Revalidation) alert
• Sample status
• Analytical report
• Certificate of analysis
• Label printing
• Trend analysis
• Supplier performance analysis
• Outstanding work load
• Monitoring of sample testing delays
• Analyst performance monitoring
• Annual/Periodic review of products
• Graphical presentation of data

Statistical process control tools

• x-chart
• X bar chart
• s-chart
• Pareto diagram
• Histogram
• Cp,Cpk calculation
• Six Sigma Monitoring