Many virtual companies feel they do not require a quality system as much of the regulated work is outsourced to other vendor companies. Shouldn’t the CMO, CRO, or Laboratory have an adequate quality system to ensure the regulations are met? While this is true on paper, it is not the expectation in practice. Both the FDA and the European Health Authorities have been clear that they expect the Sponsor to take responsibility for the oversight of all contracted vendors. This is generally accomplished by a documented, proceduralized, quality assurance audit of the vendors. So, even a virtual company of a few people will need to have a quality system that documents the vendor oversight process.
It is also important to keep the end in mind during life science product development. If the virtual company is developing a device, they may find themselves legally defined as the specification setting entity. Thus, registration with the FDA is required. This also necessitates a quality system be in place to meet Federal regulations. If the virtual company is developing a biologic or a drug, they will need to have quality agreements in place prior to conducting clinical studies overseas. They will also need to register as a private labeler, have documented proof of the qualifications of their consultants, and have documented proof of clinical study oversight. All of these tasks are best accomplished through an established quality system. While some of these expectations may seem burdensome, they really boil down to good business sense. All virtual companies need a quality system; it is just a matter of assessing which aspects are relevant, and ensuring that the system grows appropriately with the company. Safis Solutions is adept at “right sizing” your quality system, and anticipating what pieces will need to be added as the company grows.