Solutions for SMEs
The SME dilemma
In small and medium-sized enterprises (SMEs), regulatory and pharmacovigilance functions are often in the same department or team, and sometimes the team handles quality matters as well. Teams are usually small (1-10 people), but because each person tends to have multiple areas of expertise and responsibility, the calibre of person is usually high; both regulatory affairs (RA) and pharmacovigilance (PV) knowledge is required, as people are often expected to multi-task. The situation is often similar in local affiliates of larger organisations.
In situations like this it usually doesn’t make sense to have expensive, separate systems for RA and PV, as the information overlaps and the same people will be using both systems. Furthermore, multiple systems require additional user training and application maintenance. However the efficiency of the team is very important and some sort of solution is required.
Historically it’s been difficult for such teams to justify purchasing expensive systems to manage their data. Instead they usually have numerous spreadsheets with which to manage their data, and they put up with the duplication of effort and unmanageability that using spreadsheets provide. Even if a current or past employee has developed their own home-grown database, or if a complex macro-driven suite of Excel® sheets has been put together, the ongoing maintenance of this often quickly becomes a problem, especially as staff leave and/or responsibilities change.
For these businesses, the increasing electronisation of regulatory information becomes an advantage, because it makes it easier to justify the implementation of a suitable database system. Many agencies no longer accept paper submissions for example, and whilst NeeS submissions could be created manually, eCTD is becoming increasingly popular and in many cases mandatory, so an eCTD tool is required. The latest XEVMPD guidance makes having a proper EVMPD tool more attractive too; although it is of course possible to use EVWEB again to enter your data, remembering to keep it up to date as variations and new authorisations happen can significantly add to the RA professional’s workload and the risks of inadvertently falling out of compliance increase.
Samarind RMS is the perfect choice.
- All your regulatory data in one place. An end to duplicate data entry and inconsistent spreadsheets!
- Enter the data once and reuse it wherever it’s needed. This can save a huge amount of time, especially if you make good use of document templates and our unique query facilities.
- Reduce risk – in smaller teams each person tends to have specific knowledge about a particular product range. Having this information in a proper database rather than in spreadsheets or each person’s head can significantly alleviate this risk.
- A system with a built-in electronic document management system (EDMS) is often greatly welcomed by regulatory teams, as it enables important regulatory documents to be properly controlled within the system rather than the ‘free for all’ of the shared network drive.
- With Samarind RMS there’s one system to purchase, validate and learn. Why implement separate eCTD, EVMPD and tracking tools, try to integrate them and then have three systems to manage when you can have it all in one?
- Time and cost savings all round – from procurement via data entry to information management.
- There’s even the option of a drug safety module, fully integrated with the rest of the system, so if you’re currently outsourcing this function or using an Internet-based ‘pay as you go’ tool, you may be able to save time and money by taking this module too because most of the data is already in the system.
As well as the software, training and ongoing support, Samarind can also provide help with validating the system, either via our pre-built Validation Packages or by supplying on-site resource to guide you through the process. This is welcomed by most small and medium-sized businesses, as they usually have neither the time nor the expertise to author validation reports, trace matrices, PQ scripts etc etc. Samarind’s development is conducted according to GAMP5, so you benefit from the depth and thoroughness of our validation process by not having to do so much yourselves.