BIOVIA LES

Proven 25% productivity improvement, 50% reduction in cycle times, 10 x reduction in compliance risk for QA/QC operations

BIOVIA LES is the leading Laboratory Execution System for QA/QC operations with 9 out of the top 10 pharmaceutical companies using the system to support Regulatory submissions within GxP operations. BIOVIA LES delivers transformational productivity for QA/QC labs supporting common workflows such as material testing for recipes, stability testing, product release testing and post-release quality testing. BIOVIA LES is ideally suited for Quality Control laboratory testing supporting procedures such as:

• Method execution
• Calibration checks
• Data acquisition from instruments
• Calculations and data processing
• Data review
• Data exchange
• Data storage and archival

BIOVIA LES provides lab analysts with an electronic environment that removes paper processes and automates the interaction with methods, instruments, and supplies that scientists and analysts use every day, while handling this automation in a compliant and controlled way. By automating the execution of procedures BIOVIA LES removes paper based inefficiencies, liberates more resources for capacity, eliminates transcription and calculation errors that happen in paper-based and disjointed systems, and accelerates reporting and review cycles while reducing costs.

Customers report the following operational improvements:

Cycle Time Reductions:

• "50% Reduction"
• "Instant Access to Information"
• "75% Faster Overall Process"
• "When you’re done, you’re done – no more paperwork!"

Productivity Gains:

• "50% Elimination of Data Review"
• "20+% Labor Content Liberated"
• "43% Resource Reduction"
• "We went from 10-15 error investigations/month to ZERO"

Reduced FDA Compliance Risk:

• "Proper Recording…Enforced Method Execution and Review"
• "Platform for Right-First-Time"
• "60% Labor is Paperwork, Causes Increased Errors"

Remove Challenges of Paper Based Processes

From the point a sample enters the lab until a final test result is reported, most tasks executed by lab analysts are documented in paper. Analysts often reference a hard-copy Standard Operating Procedure (SOP), either in a binder or as a printout. Compounding the problem is having to cross reference everything that involves the execution of that SOP, such as verification of instrument calibration, pedigree of supplies used, and any notes that a lab analyst may also record. Analysts are also burdened by tedious manual transcriptions of test results into forms, either paper based or electronic forms in LIMS, which is not only a non-value adding activity but also error-prone And bearing compliance risks. It’s no wonder that a significant portion of an analyst’s day is spent doing paperwork, not science!

With BIOVIA LES users will:

• View only the current and approved SOP "under glass"
• Execute test with method onscreen, without switching screens
• Capture instrument data electronically
• Validate calculations with a single click
• Handle data review on a dashboard, without of piles of paper
• Finish your work error free and on time

Streamline Your Review Process

In paper-based data review processes, the most significant time sink is that reviewers need to look at everything. Given the volumes of data produced on a daily basis, it would be easy to overlook a mistake that might cause an investigation later on. Not only is the review process time consuming, but the resulting rework loops cost significant time and materials.

Lab notebooks, log books, data packets, and data entry forms all have to be checked and rechecked for accuracy and authenticity to verify that raw data are retained to support results and address the following questions.

A streamlined review process with BIOVIA LES enables:

• "Review by exception" – deviations are with a color-coded flag on the data review dashboard with link to reports and audit trails
• Compliance – capture of audit trails, electronic signatures, reasons for change, and annotations
• Elimination of transcription and calculation errors - validated calculations within validated procedures
• Easy investigations - sample ID, user ID, method, preparation data, and results are dynamically linked