Click any of the questions below to find your answers.

1. What is a lab execution system?
2. What do you mean by the term “automated method execution”?
3. How does the SmartLab notebook integrate with my lab instruments?
4. How does the SmartLab Electronic Notebook System interoperate with my other IT systems currently in my lab – such as LIMS, Chromatography Data Systems (CDS) and ERP systems?
5. Why is SmartLab referred to as a “GMP Electronic Notebook System” instead of just an ELN (electronic lab notebook)?
6. How does the SmartLab solution differ from a Laboratory Information Management System (LIMS)?
7. How can I assess the impact and costs to implement the SmartLab Electronic Notebook System?
8. How can I get started quickly and try out the SmartLab solution?
9. How do I load my methods into the SmartLab system?
10. Who uses the SmartLab system and what benefits have they reported?
11. What can I do to assess SmartLab in my environment?
12. What validation support does VelQuest provide?

 

Q1)What is a lab execution system?

The SmartLab GMP Lab Execution System (LES) and Electronic Notebook System is a purpose-built QA/QC software platform designed for analysts, reviewers and supervisors to manage the entire process of executing laboratory test procedures in a paperless environment while maintaining cGMP requirements for compliant data capture, documentation, review and transfer. The foundation of the system is an automated "Procedure Execution System" where the user GUI IS the actual procedure/SOP/Word document to be followed.  The system automates the analyst’s method execution and integrates all lab instruments within the context of the test method. The solution is ideal for late stage development and quality control environments.  Regulatory mandates state that, for cGMP operations, written procedures shall be established and followed.  The SmartLab system absolutely ensures that the regulatory requirement is adhered to every hour of every day.

Q2) What do you mean by the term “automated method execution”?

When using the SmartLab Lab Execution System and ELN, analysts call up their test method “under glass” (tablet PC, etc.) based on their security privileges. Embedded in the actual document are data and metadata triggers to open up the data capture fields at the bottom of the PC. The analyst simply enters the needed information or automatically captures the information directly from the instruments (balance, pH meter, spectrophotometer, HPLC, particle size analyzer, dissolution apparatus etc.). This automation eliminates transcription errors and ensures compliant data capture electronically – direct to database.  For some of our customers, the use of a worksheet or forms-based approach can be implemented.  This is useful for some application areas such as environmental testing (micro).  Forms or full method automation - either can be implemented in the SmartLab system.

Q3) How does the SmartLab notebook integrate with my lab instruments?

The SmartLab system interoperates with ALL instruments in the QC lab. For “simple” instruments, such as balances, pH meters, titrators etc. that have typically RS232 output, an inexpensive protocol converter is attached to the instrument allowing the data stream to be network compatible. For more “complex” PC driven instruments (HPLC’s, spectrophotometers etc.), SmartLab utilizes the printing functions of the instrument software with a SmartLab print driver. The system captures the printout as a pdf image and automatically parses and transcribes the needed QC method information/data to the VelQuest database. In addition, the entire pdf image is saved for review purposes.  Over the last decade, VelQuest has integrated to over 90% of the instruments used in QC testing.  These connections are in our Instrument Library, allowing the SmartLab system to be connected to all your instruments in a matter of a few days.

Q4) How does the SmartLab Electronic Notebook System interoperate with my other IT systems currently in my lab – such as LIMS, Chromatography Data Systems (CDS) and ERP systems?

SmartLab contains an XML based data exchange module that provides an input and output structure to interoperate with other IT systems. This “adaptor” technology is easily configured to any LIMS, any CDS system and/or direct interaction with traditional ERP systems. In fact, several of our users have decided to eliminate the LIMS administration functions of their IT structure and go direct to their ERP system with final reviewed and approved data from the SmartLab system.  

Q5) Why is SmartLab referred to as a “GMP Electronic Notebook System” instead of just an ELN (electronic lab notebook)?

SmartLab is a “purpose-built” method or lab execution system for cGMP operations. It is not a general purpose, open ended, free form ELN for general purpose R&D-like use. The cGMP lab environment is VelQuest’s only focus and, as such, the SmartLab GMP Electronic Notebook System contains all the specific GMP related details for compliant data capture and documentation requirements. It is, in fact, a Procedure Execution System, as the user GUI is the actual document that must be followed.  SmartLab provides a systematic and disciplined approach to ensure that only the latest approved methods are available to analysts that are trained on the method – it ensures that only calibrated instruments are used in the process and that all supplies are in date. In addition, procedure data thresholds for each step in the process allows the “system” to flag any data element that falls outside of the expected normal range thus establishing a “right first time” process for the QC lab.

Q6) How does the SmartLab solution differ from a Laboratory Information Management System (LIMS)?

In fact, SmartLab can be PART of a LIMS initiative at any company. The “Total LIMS” requirements have both an administration function and a lab execution function. Traditional LIMS deployments require substantial custom coding and validation in an attempt to integrate with the laboratory processes (analysts and instruments). VelQuest provides a COTS (commercial off-the-shelf) product that fully integrates with any LIMS solution and eliminates the costs and time constraints when attempting to drive a LIMS technology into the lab environment. The LIMS administration functions such as sample management, trending, reporting etc. can be implemented quickly with SmartLab integrating the entire “lab execution” tasks. In doing this your LIMS initiative can be completed in far less the time and costs of attempting to do the whole job using only the LIMS custom coding process. Our users refer to this strategy as a “thin LIMS” deployment.

Q7) How can I assess the impact and costs to implement the SmartLab Electronic Notebook System?

VelQuest can perform a Business Impact Planning Phase to scope and assess an implementation plan for your site or multi-site operation. Included in the BIPP is a full analysis of your paper-based workflow along with a lab survey and infrastructure requirements. The analysis will detail an “all-in” estimate of project costs (client and VelQuest costs) and a financial analysis on projected payback period (ROI, IRR etc.). Included in the BIPP is an initial deployment of the software for testing in a non-validated environment for clients to experience the benefits of the system before validation and roll-out.

Q8) How can I get started quickly and try out the SmartLab solution?

In addition to the Business Impact Planning Phase (see Q7), VelQuest has configured our SmartLab Pilot Program to provide both a validated or non-validated deployment in specific high volume, high automation benefit areas in the QC operation. The Pilot Program typically includes 5 user licenses, 5 instrument connections and 5 test methods configurations to “go-live” in your cGMP area in as little as a few weeks. The Pilot Program is a full deployment of SmartLab, so users can extend the use at any time. Included in the Pilot Program includes installation, training and full validation of the system. You can test it out there and add more later. Typical Pilot Program application areas incude: Raw Materials Testing (USP-based), Calibration/Metrology, Solutions Preparation and Chemical Inventory, Finished Product Testing including Content Uniformity, Dissolution and Assay, and LIMS Instrument Integration.  Our Pilot Program can be configured for your specific requirements – contact your VelQuest representative for details.

Q9) How do I load my methods into the SmartLab system?

Your existing method documents are simply used within the SmartLab MethodBuilder technology. SmartLab MethodBuilder is an automation software tool to create SmartLab methods from existing procedures or test method documents (eg. Word documents). The tool contains a library of pre-validated laboratory unit operations (eg. Weighing, Mixing etc.) as “functional objects” that can be easily dragged and dropped into a document to create a SmartLab executable procedure or method. The unit operations contain all the underlying software code to work in the SmartLab GMP Electronic Notebook System. In addition the MethodBuilder contains a Qualification Engine to automatically create a flow chart of the procedure/method and the test script for procedure qualification.

The unit operations can, in turn, be linked together to create “Sections” of functionality that is specific to various types of methods such as buffer preparation or mobile phase preparation. In turn, those blocks can be saved in the library and linked to create method “Test Methods” such as dissolution or content uniformity. By preparing your method with MethodBuilder, you can totally automate the method conversion process including documentation and qualification from paper to SmartLab.

Q10) Who uses the SmartLab system and what benefits have they reported?

VelQuest co-sponsors the annual International Meeting on Automated Compliance Systems (IMACS) where users report their experiences and management metrics. Typical benefits include 50-75% reduction in review cycle times and reporting, 20% + overall cost reductions usually achieved by significant reductions in review resources and large improvements in error reductions and overall cycle times for just-in-time manufacturing release initiatives. In analyzing the return on investments for this technology, typical returns are achieved in 6 months to 1.5 years depending on the environments. Reporting companies include: AstraZeneca, Bristol-Myers Squibb, Eli Lilly & Company, McNeil Consumer Healthcare, GlaxoSmithKline, Forest Labs, Meda Pharmaceuticals, Nycomed, Forest Labs and many more. For more information on IMACS go to www.imacs-world.com.

Q11) What can I do to assess SmartLab in my environment?

VelQuest would be pleased to conduct a web presentation to your group at a time and date convenient to you. Also, we can visit your facility/plant and conduct an executive briefing with your key senior managers, QC/QA organization and your IT group that supports cGMP operations. Then we can conduct our Business Impact Planning Phase and produce a report complete with a full financial review for your senior management. You can then implement a Pilot Program configuration in a key area (eg. Raw materials) at a low cost and gather experience and your own metrics in an actual cGMP deployment. With our training and validation documents, you can extend the use across all your development and QC operation.

Q12) What validation support does VelQuest provide?

As mentioned above, VelQuest’s SmartLab Electronic Notebook System is “purpose-built” for cGMP quality lab use. It is an off the shelf PRODUCT (vs. a custom IT/IS Project).  The implementation of the platform includes a full documentation suite for IQ and OQ support. The validation can be implemented by our customers or with full or partial VelQuest services. Our documentation suite can be used as is or modified by our customers’ documentation group. In addition, our services include PQ and PV support in conjunction with user requirements.