Business Benefits and Data Integrity with LabX

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.