In today’s technology-driven world sharing of information is now easier than ever. With rapidly advancing technology and continuously evolving digital systems, the means of sharing of information are also aplenty. With so many individual ways of sharing information, it has also become more imperative than ever to safeguard and prevent any misuse, hacking or confidentiality breach of information.
The client-CMO collaboration starts with a confidentiality and non-disclosure agreement. A CMO service provider, while undertaking client projects, generates no proprietary intellectual property. The ownership of all data generated rests with clients. That is why good CDMOs know the importance of establishing secure IT systems and infrastructure which gives clients the confidence they need about the security of their data. It is imperative to not only implement digital systems but also educate and counsel users to advance the adoption of emerging technologies. This must accompany the implementation of stringent confidentiality and IT policies with well-defined protocols. Extensive training on IT policies and protocols should be extended to stakeholders with access to confidential information.
Implementation of ERP system, LIMS QMS, DMS, electronic lab notebooks, EMPOWER (and few other advanced) HPLC activity tracking systems, CSV (computer system validation), automation servers, web-based accessing of real-time data (by client), allow for an end to end data protection. At the same time, at the individual level, monitoring & restricting access to computer activities is important.
While companies strive and safeguard own information, the government of almost all major countries – US (CCPA/privacy act), UK (Data protection act), EU (GDPR) and others - are either contemplating or already have implemented regulations that protect their citizen data. Personal data records of clients such as name, email addresses, contacts, etc. which may be gathered by service providers need to be documented, traceable and removable upon request.
Data security is an issue client must consider and evaluate while selecting a CMO partner. Not only CDMOs but also outsourcing companies need to become aware of advanced or more secured technologies to safeguard their data.