Will bioassays and mycoplasma-detection technology run the market distance?
There are over 200,000 thousand laboratories in the United States alone1 and additional life science companies also include pharmaceutical, medical device, biotechnology and blood/tissue organizations. Most of these companies are usually respected within their production and sales communities and some companies even rise to the brilliant flavor of scientific ideas that have the potential to affect so many lives for the better.
However, even the outstanding life science companies can forget that ideas are only ideas until they are implemented and that the manner in which those ideas are produced can, in the long term, greatly affect the future successes of the company itself. For instance, even some of the most brilliant life science companies have less than brilliant quality systems and fail to comply with FDA, ISO, EMEA (Europe), and SOX regulations efficiently and quickly. Most life science companies also needlessly separate their quality system processes and their regulatory compliance processes and even more amazingly still use manual or hybrid processes, which in the long run are costing them more time, more money and more loyal and intelligent employees.
The Quality System Problem
As would be expected many life science companies place emphasis and prioritized importance on the research and development phases as well as the design and engineering phases of product development. The problem arises when the quality department is left to sweep up messes (without a fast and effective quality system) that could easily have been prevented by earlier detection and increased communication across all departments.
Mycoplasma Bioassays: Is your product destined to become just another part of a quality system flop?
One piece of online content located on a life science website1 discusses one of its life science products, a mycoplasma bioassay.
The Product
This mycoplasma product is potentially very impactful (and perhaps already is) since the mycoplasma are actually microorganisms that are parasitic and make up the prokaryotes that can contribute to tract infections in the urinary system or to pneumonia. The mycoplasma bioassays allow product purchasers to determine levels of mycoplasma and take appurtenant actions.
So, all is well right? Not exactly. Let’s say for instance that the “manufacturing phase” of the mycoplasma bioassays has been delayed due to an error by the research and development department. Now, all relevant documentation must be revised, reapproved and rearchived to meet regulatory compliance standards, not to mention the safety of the user. This delay is likely to cost hundreds (if not thousands or tens of thousands) of excess dollars since the man hours involved in relocating the documentation, revising it, rerouting it and getting it reapproved will be many, not to mention the time it will take to organize the appropriate training (also to meet compliance regulations) associated with the revised documentation. Then, once training associated with the documentation has occurred across applicable departments, what if some of the old documentation remains in the lab or the manufacturing/production area and is used mistakenly by careless employees? Then, if product malfunctions occur (which is likely) products will have to be recalled and once again documentation must be created, routed and reapproved much to the disillusion of everyone involved.
Not exactly the ideal quality system….
A Quality System that Makes Sense
This scenario is a common one and lowers the power of a company to produce additional products in the future. However, the problem can be solved effectively if life science professionals would choose to view a quality system as a system across departments instead of as the lone quality department left to manual or hybrid processes. A quality system, for instance, should be electronically based, should have a protected and centralized archiving system and should create checks and precise routing techniques that assure an understanding of the products’ state before it goes to design, engineering, production or any phase of its development.
Often, a problem lies not in a company’s ability to think creatively or to build innovative environments but in a simple “balance the budget” mentality. Integrated quality system software can help companies save time, money and future innovations.