1. We have limited resources for doing an instrument integration project. How can CSols help?

In comparison with other projects such as LIMS or CDS implementation, instrument integration is less demanding in both time and resources. Typical instrument integration projects are completed in 2 to 3 months. CSols offers a complete range of implementation services that will ensure the system is implemented successfully, both on-time and on-budget.

2. Why should we use CSols consultancy or Informatics implementation services?

Laboratory Informatics is our specialty. We have a proven track record in instrument integration, strategic planning, and informatics system implementation. We have been called in to help out customers when internal efforts have stalled or failed. We have had potential clients tell us that they have purchased a LIMS system but have not yet implemented it.

3. Why should we use CSols validation services?"

CSols informatics specialists have worked in the Pharmaceutical industry working on and managing large scale computer systems validation projects. They learned validation while working in the Pharmaceutical industry. They have extensive validation experience and knowledge. While working in the industry, their efforts have been audited by internal compliance departments, externalcustomers and the FDA.

CSols has provided validation services to some of the largest and fastest growing Pharmaceutical and Biotech companies in the industry; and our customer base continues to grow.

4. Has a validation effort that CSols has worked on for a Pharmaceutical or Biotech customer ever been audited by the FDA?

Yes. A LIMS validation effort that CSols helped perform was audited by the FDA during a routine inspection. The validation effort was found to be acceptable with only a few minor observations. No 483s were issued.

5. How will Links for LIMS add value to our organization?

Instrument-LIMS integration improves efficiency and quality in the laboratory by automating the manual data handling processes. Automation eliminates transcription errors and improves consistency and throughput which results in higher quality results. Higher efficiency means that the laboratory's product - its data, gets to those that need it faster. For manufacturers this means critical production process decisions (e.g. raw material release, in-process testing, product release) can be made faster and with greater confidence. For R&D laboratories, this can contribute to faster time-to-market for new products.

Also, Pharmaceutical manufacturers must comply with the FDA regulations such as 21 CFR Part 11 (Electronics Records & Electronic Signatures). These regulation impacts virtually all aspects of the manufacturing process including the laboratory. Links for LIMS is Part 11 compliant. CSols also develops Links for LIMS using SDLC methodology. Our testing documentation is available to our customers. This results in a reduced validation effort at the customer site.

6. Data from my instrument systems must be manipulated and/or reviewed before it is ready for our LIMS. Can Links for LIMS help automate the processes our scientists perform manually?

Yes. This is the most significant value Links for LIMS can add to the laboratory. Rarely is data that is output directly from instruments or data systems ready for LIMS. It often requires further work-up or manipulation. It must also be properly identified so that it can be reviewed and/or manipulated before it is transferred to LIMS. Link for LIMS can be used to automate this transitional data handling step.

7. What instruments should we interface with LIMS? What instruments has CSols interfaced and to what LIMS?

Some instruments or data systems are better candidates than others. High volume systems should be a priority. Instruments that generate only a couple of results per day are likely not good candidates. Also examine the effort required to manually set-up instrument runs, and the effort required to produce a "LIMS ready" result from data generated by the instruments. If significant time savings can be obtained via automation, then these instruments are good linking candidates.

CSols has interfaced hundreds of different instruments to LIMS of all different types from balances and pH meters to the most complex robotic systems. A list is available on the Instrument Interfacing page of the website. CSols supports all major LIMS products and we have interfaced to in-house developed LIMS systems.

8. How does CSols Links for LIMS differ from a commercial archiving solution such as Nugenesis®, eRecordManager®, or CyberLab®; or an electronic notebook solution such as that offered by Velquest®?

Links for LIMS automates the bi-directional transfer of sample, method, specification and results between a LIMS systems and an instrumentation systems in real time. The data that Links for LIMS handles is used for decision making purposes (e.g. release a product, continue a study, or decide if a formulation is suitable).

Archiving solutions are primarily focused on meeting the record retention and historical retrieval requirements AFTER the operational decisions have been made.

Electronic notebooks are focused on procedural-based compliance by ensuring that the decisions made by the analyst follow the SOPs and that those decisions are documented.

There is minimal competitive overlap between an electronic notebook and Links for LIMS. In fact, VelQuest and Links for LIMS have been successfully deployed together in a major Pharmaceutical R&D company. Links for LIMS focuses on optimizing the data transfer process, whereas Velquest focuses on ensuring that the process (optimized or not) is followed. As such, they fit together very well.

9. Why do I need to purchase Links for LIMS when the LIMS vendor we purchased from already offers an instrument linking utility?

CSols is an industry leaders in instrument integration, and this is our core business. We are advanced instrument integration specialists. It is common for potential clients to tell us that they have purchased X numbers of licenses for instrument integration along with their LIMS but never implemented them. With CSols professional services and products, you don't pay for non-functioning interfaces.

Another key consideration is that Links for LIMS can be deployed in the same way for any LIMS. Many large companies have a mixture of LIMS solutions from in-house systems to commercial products, yet they have the same instrument integration needs. By picking a solution that is independent of any particular LIMS vendor, you can achieve economies of scale and simplify support.

10. How long will Links for LIMS take to pay for itself?

Unfortunately there is no precise answer. We do know from our customers that the resulting benefit to their business can far exceed the time saved in the laboratory. These benefits can be difficult to measure, and more difficult to quantify. Based on time savings for the laboratory, Links for LIMS systems typically have a payback period of 6 to 12 months.