Business Benefits and Data Integrity with LabX

Process Automation

A study about risks and benefits, advantages and disadvantages of different systems used in laboratories and their business benefits and return on investments.

The objective of this white paper is to demonstrate that an investment in LabX can bring substantial business benefits to both a laboratory and its parent organization, such as:

Business benefits obtained from automating chemical analyses in GMP regulated labs
Cash flow benefits following from earlier release of products
Compliance cost benefits by ensuring data integrity for chemical analyses

There is an implicit expectation, with the FDA and European regulatory authorities, that the pharmaceutical industry keep up to date. This is best illustrated with 21 CFR 211 on Current Good Manufacturing Practices (CGMP) for Finished Pharmaceutical Goods –the key word is “current”. The preamble to the 1978 CGMP publication states that the meaning of “current” is that industry should keep up-to-date with new advances where one contributes to drug quality. The current situation in many GMP laboratories is that many are paper based and working practices have hardly changed over last decades. In fact, the FDA Guide to Inspection of Pharmaceutical Quality Control Laboratories issued in 1993 is still relevant a quarter of a century after publication as many working practices in regulated laboratories have not changed substantially. Many laboratories still work using:

Manual processes
Blank forms
Hybrid systems
Spreadsheets to perform calculations

The problem is that these approaches do not enhance data integrity and also result in higher second person review and administrative overheads – generating more costs.

Overall, the benefits of automating with LabX for the laboratory are time saving in performing the work, allowing an increase in capacity, and the potential to release product earlier than with a manual process. Review can be automated, which allows for the possibility of reviewing audit trails by exception.

Current situation: QC is at the end of the process and everybody waits until testing is complete before batch release.

See the impact of this on company cash flow of earlier release to market
Potential calculation – If a batch is worth $1m and it takes 10 days to release what would be the benefit to the company if the release was reduced to 9 days?

This white paper demonstrates with examples and charts the advantages of transition from a manual, paper based process to an automated process using an analytical balance and a pH meter (instruments common to every lab) as an example. The automation of the process and the time savings coupled with ensuring data integrity in a regulated GMP laboratory fully offset the purchase and validation costs of the system. Ultimately, combining LabX instrument control software to an ELN, LES or LIMS system brings the most benefit of workflow efficiency, data integrity support and total cost of ownership savings. And finally, after the short term pay back of the validated LabX system, and as the long term savings multiply in efficiency and batch release effort, an even the larger scale benefit is realized in the removal of the cost of 'non-compliance'.