Outsourced Enterprise Compliance and Quality Management — application and data management in the form of Software as a Service (SaaS) — is a partnership needed more today than ever, particularly in the increasingly complex regulatory environment that Pharma, Biotech and Medical Device companies find themselves.
Historically, these Life Sciences companies maintained their systems and data in-house and went through the traditional and ongoing challenges of software upgrades, database administration, validation and dealing with software vendors. There is nothing wrong with this, but resources are often thin, and this alone can lead to additional work being placed on already stretched staffing.
These activities frequently cause distractions, which pull people away from the primary objective of developing new therapies. Most Life Sciences companies are dealing with increasing constraints on time, money and resources. Additionally, there is added pressure from the executive level to decrease costs while improving results.
Some of the upcoming regulations will place an even greater strain on such companies’ in-house systems and their maintenance. These include the proposed New Rules for Medical Devices which were published by the EU in October of this year. These include:
- Stronger supervision of the notified bodies by national authorities
- Better coordination between national surveillance authorities
- More powers for notified bodies, including unannounced audits and sample testing
- Extended database on medical devices, providing the possibility for publicly available information
- Better traceability of medical devices with a Unique Device Identification System
- Stricter requirements for clinical evidence
- New classification of medical devices containing nano particles
- Revision of the conformity assessment of class III products by an EU body
Interestingly, these are planned as regulations and no longer directives.
The old reasons companies did not implement SaaS no longer apply. Network bandwidth has come of age, and software has been running on the Web for almost 15 years and is usable and practical. User interfaces are also improving. There is no discernible difference between the performance of an in-house or outsourced system.
European companies rightly had reservations about the safety of their data in the U.S., but with more companies now gaining Safe Harbor Certification, that concern is alleviated. Even as so many Life Sciences companies expand their operations into Third World or developing countries, there has been no problem with Internet access. Indeed, most of these countries have better Internet and telephone connections than industrialized nations because their infrastructures are brand new and state of the art.
No longer can SaaS be seen as a puzzle. The user will see exactly the same content, the software is the same, support is the same and as long as certain fundamentals are adhered to (see “Safe Harbor” above), and the supplier has a record of, or an ongoing commitment to SaaS, then this author can see no reason for putting off SaaS any longer.
Most of the larger Enterprise Compliance and Quality Management Systems will have CAPA, Complaint, Document, Training, Reporting and Audit covered. This is a huge advantage because these products will have been tested by specialists—the system designers—and the regulatory authorities. They are smart, efficient and have good interfaces with both the system itself and experience with the authorities.
Given that SaaS now is an option for most Life Sciences companies, it is important to consider what a smaller to mid-size company can do if it doesn’t have a budget for an in-house system. Concerning budget, it is important to remember that it comprises not only the cost of buying a system but also the cost of implementing, running and maintaining it, and the cost of users to input and analyze data.
These smaller to mid-size companies are ideally suited to an outsourced system and its many advantages. These include mostly fixed and predictable costs, reduced overhead and someone else to manage day-to-day administration.
The savings are not only financial; there is peace of mind knowing that the providers have experience and that this is their job. There is the relief of the burden of maintaining another in-house system. And probably greatest of all, there is no need to provide 24-hour support.
A larger company looking to outsource some of its EQMS work, on the other hand, could achieve all of the benefits described above without having to waste the time and effort already spent in implementing their in-house system.
Often, the biggest concern of middle management in large Life Science enterprises is the restriction on headcount. Departments are bursting at the seams, and there is neither the will nor the ability to add more. Outsourcing some of the more arduous or time consuming tasks often is the answer. However, there is also the need to know that these tasks are being performed to the required regulations and standards, and at the required speed.
It should be fairly easy to choose a vendor who runs the same system or has experience of the system in-house. There is no need for in-depth training, just some low-level familiarization with configuration.
It is important to reiterate that one of the biggest advantages for any company is the relief of the burden of maintaining the system. This enables the company not only to do its “real” job – bringing new products to market – but also to do it efficiently with good, clean, validated data. The time of SaaS definitely is upon us.