A quality system and corresponding procedures are often seen as a necessary evil. People have to comply to rules and regulations which they believe are slowing down their processes and activities. They experience that a great part of their work is administration which is not the occupation they applied for. I actually once had a colleague who quit her job in clinical research because of all these extra registry activities. A quality requirement can be missed when there is a lot of pressure, especially by people who are creators and analysists and less structured by nature. When an audit is planned, a lot of checking and extra work is needed to get it all fixed and complete.
This is contrary to the principles of the regulations and guidelines on which the procedures are based. These principles have the intend to improve the efficiency and effectiveness of clinical studies; Being clear in responsibilities will make sure that things will happen by the right persons at the right moment and are not overlooked. Traceability of data will make sure that you can reproduce and validate your results. Documentation and descriptions of the process will make sure 33that the processes are easily transferable to other employees and stakeholders. And for clinical research, rules regarding blinding, safety reporting and so on will make sure that the results are sound and that the safety of (future) patients is guaranteed. Standards will make sure that data is easily transferable and reports can easily be reviewed. These are all measures that every good process engineer would implement to get his company running smoothly and effectively. So what is going wrong here?
Procedures are in most cases written by people who have the drive to create certainty and clarity. However, their pitfall is that they tend to include too many details and are creating new rules for every problem and exception. This makes procedures extensive and complex. In addition, procedures are in many cases copied from standards or examples which do not reflect the actual activities in the company.
Each company is different, has different processes, different size and different missions and visions. Of course, there are distinctions between CROs and pharma companies but also within these two subbranches of our industry there are a lot of variations. That means that while the principles are the same, the procedures between companies should differ. A big sized company needs more registration than a small sized company. Simply because there are more people involved. For a small sized company, the same requirements can often be secured by means of alternative processes which need less registration but includes more responsibility for a particular role.
A pharma company has often one standard for their processes on which the procedures are based while a CRO has many clients, so they need to be more flexible to comply to the requirements of their different clients. What I have seen a number of times is a big pharma company auditing a small CRO. The auditor expects the CRO to have the same detailed procedures as they have themselves and the CRO, being client focussed, is changing their processes towards all these expectations. At the end the CRO processes get more and more complex and tend to outgrow the companies means.
So what I am proposing here, is to stay flexible without overlooking the rules and regulations and what principles they were based on. While writing the procedures, keep in mind the normal processes of the company and what is needed to be efficient in these processes. Keep the procedures lean and mean so that they can be used in daily practice. Then your procedures will support your processes and improve the efficiency instead of decline the efficiency.
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