It has almost become routine: under narratives of increased patient safety and improved efficiency new regulatory requirements are developed, resulting in increased requirements on the industry. The new European pharmacovigilance legislation and the upcoming European medical device regulatory updates are only two examples. Being part of the industry you have very limited impact on the regulations but have to comply with them anyway. That is – if you were to continue marketing your device or drug. Under certain circumstances the cost of meeting legal requirements is so great it may bring into question the viability of continuing certain business activities. This is especially the case for smaller companies or niche products.
- The quality system is, in itself, a high maintenance object which consumes ongoing resources:
- It needs to be revisited often due to changes in the regulatory system or in the business environment.
- Each change may affect many components of the system and a quick modification may cause inconsistency.
- Each modification needs to be accepted, signed-off formally by several people and be disseminated via formally recorded training.
- The organization should withstand audits and inspections in regards to the quality system.
- Living with the quality system: Each SOP and work instruction has to be followed, and typically forms need to be filled, signed and filed.
Young companies which are just embarking on the regulatory path often do not realize these two characteristics of the quality system. Quick fixes in the form of SOP texts copied from other organizations or generic templates are being used to get the initial certification. However, as the organization evolves it realizes that a quality system is not a one-time effort and cannot be glued on from external sources. It has to be streamlined and become part of the way that the organization lives and does business. Companies are enjoying the benefits of improved process design and automation on a large scale every day, in many areas. When recently did you see a delivery person arriving to a pickup without a Barcode reader, so that he does not need to fill any form manually? When was the last time that a software package was released without an automatic consistency check? So too your quality system and related processes may be dramatically engineered to serve you better.