Here are some of the questions that people typically ask when considering Samarind RMS as their regulatory management system.
If you have a question that is not covered below please don't hesitate to contact us.
Q: Which version is best for me, the Windows one or the 'On Demand' one?
A: The Windows® version of Samarind RMS is more suited to larger companies with an established in-house regulatory affairs team and reasonably large numbers of both licences and users. RMS On Demand is aimed more at smaller companies and regulatory affairs consultants, who are managing smaller numbers of licences and might not have the IT infrastructure or resources necessary to implement the Windows system. Having said that, the two systems share a common database architecture and both are excellent tools in either environment; it's primarily the pricing model that's different. For full details of the differences between the two versions please see our product comparison page.
Q: Can I upgrade from the 'On Demand' version to the Windows one?
A: Yes. Because the database structure is identical, it's straightforward to upgrade from Samarind RMS On Demand to the full-blown Windows version. Just contact our sales team for more information.
Q: Is the system validated?
A: In our experience 'validation' means different things to different people, despite the regulation in the pharmaceutical industry. We have several customers who have validated the system, all to different degrees, according to their company style and the perceived risk surrounding their usage of the system. Whilst we are not permitted to share any customer's validation documentation with any other customer, we have a lot of experience in helping with the validation process and would be glad to assist where necessary.
Q: Is the system suitable for use in the US?
A: Although Samarind RMS was initially developed in collaboration with various European customers it is now moving further afield and we expect to be supporting USA and Canada procedures later this year. If you are interested in this and would like to have an input into our product development process, please get in touch - it could be worth your while!
Q: What do you do when rules/regulations change?
A: We are all aware that the rules and regulations that Regulatory Affairs professionals need to abide by change quite frequently. Samarind keeps a close eye on what's going on in the regulatory world and is in close contact with its customers, and our programme of continual product improvement ensures that the software changes as quickly as necessary to keep abreast of such changes.
Q: Can the system be changed just for me?
A: Many customers have quite specific requirements, which are usually a reflection of their company practices or their personal particular ways of doing things, and we are sometimes asked to change the software just for them. We can do this, but our aim is always to either genericise the request (eg rather than use a particular company's terminology we try to find a general, more universally understood one) or we make it a configurable feature, so that it can be 'turned off' for most customers and only 'turned on' for the company that asked for it. We do not want to end up with 20 different versions of Samarind RMS all with slightly different features in them; that would be a maintenance nightmare, and if we let one company's version diverge then they would not benefit from enhancements made to the main system. So, the answer is yes, but it would still be part of the same system.
If you have a question that is not covered above please don't hesitate to contact us.