In the process of developing and testing a drug candidate or handling of biospecimens, the samples you hold need to meet an evolving set of proprietary, legal and ethical restrictions that apply in biosciences. Such compliance may simply be project-based, or may need to be applied and traced across companies due to the increased number of collaborations between pharma, biotech and academia . This blog will discuss the use of Restrictions applied to inventory samples and/or their containers. Managing restrictions is a wide topic and other aspects will discussed separately.
Having spent time and effort in either preparing samples for your project or securing them from external sources, what are the different options and cases you might need to consider in order to restrict their use to your project?
- Scenario One:- You’ve synthesised or acquired the latest sample(s) for your project. How do you ensure that your precious sample(s) are for your project use only and not requested for inappropriate assays before you’ve had time to address the project’s interest in the sample?
- Scenario Two:- Your project has had one of its molecules accepted as a drug candidate. Since it is now entering a more controlled phase of the regulatory process it is essential to manage any use of this compound.
- Scenario Three:- A number of samples/batches of your substance of interest exist, and you want to reserve one container solely for your project’s use. However, you are happy for other containers/batches to be requested for other projects.
- Scenario Four:- Your work requires the department to store and use small amounts of controlled substances, for which you have a licence. You must therefore have a robust method of ensuring that only authorised people can request and use controlled substances from your inventory, and any use is captured in an audit trail.
- Scenario Five:- You have a collaboration with an academic institute working with biological samples, for example, vials of blood. Approval is required before any vial can be used, plus it can only be used by those projects which have permission.
What type of management might each of these restrictions need in your inventory software? What sort of information needs to be stored about the sample, its processing and its container to ensure these restrictions are met? Are these restrictions short-term or do they cover the life cycle of the sample?
Titian’s Mosaic sample management software offers a variety of Restriction Types in order to make it easy to manage your samples to comply with each of the above scenarios.
Let’s look more closely at the requirements in each case:
Scenario One: Your project use only
Questions that you need to consider are:
- Do you just need to restrict the submitted sample? Or should you include any children created from it (for example plates or tubes) as well?
- How long does the restriction need to be applied for? Is it a fixed time, for example 6 months after which is it optionally renewable, or does it never expire?
- What authorisations are needed for project members and others? Are project members automatically authorised to request the sample? Does everyone else require approval before their request is allowed? Or do you want to prevent everyone outside the project from even requesting the sample whilst the restriction is in force?
Is your sample tracking system capable of logging and managing such requirements? If not, you will need to consider updating it.
Titian’s Mosaic sample management software is designed to make it easy to comply with different sample restrictions. You can either apply a Labware Item Restriction for the submitted labware barcode, which would apply to just the sample, or use a Substance Restriction (normally at the batch level) which will restrict all children of that sample as well. If an expiry date has been set, then notification emails can be sent to the restriction approvers in advance, allowing them to decide if the restriction needs to be extended or not. Authorisations can be set at a number of levels.
Scenario Two: Track any use
This is a more restrictive example of scenario one, where it is essential to track exactly who is requesting the sample and for what purpose. Here any sample of the substance (including children) would need to get approval before it is used, and these restrictions should never expire.
In Mosaic software a Substance Restriction at the substance level with no expiry date would manage this case.
Scenario Three: Reserve one sample container
In Mosaic software, a Labware Item Restriction is applied to the specific labware barcode(s) to be restricted. No restriction is applied to all other sample containers. Provided one of these non-restricted containers is suitable for a sample request then the most appropriate will be used without any restriction. If these additional samples have been used up then the restricted labware item will be protected.
Scenario Four: Managing controlled substances
Controlled Substances are a particular case and require special handling and an audit trail which manages:
- where a controlled substance is stored
- who is able to see the inventory data on controlled samples
- who can request a controlled sample
- who can dispense a controlled sample
As a further complication, different regulatory authorities have different lists of Controlled Substances. Whilst the majority will be common to all and hence the restriction will apply whether the sample is to be shipped or not, other Controlled Substances are country specific. How data is managed between systems when shipping is also a point to consider.
In Mosaic software, Substance Restriction is set at the Compound ID level, along with secure storage and tracking. Together these control the substance at a detailed level. Mosaic can be configured to record that an action on a controlled substance was witnessed by a third party: for example, whilst weighing out the required sample. As with all actions in Mosaic, this is stored as part of the audit trail and can be used to create reports as required. Mosaic also manages shipping requests for substances, including controlled substances. Controlled Substance data may originate from either in-house data or via third-party services such as ChemAxon’s Compliance Checker or Scitegrity's Controlled Substances Squared.
Scenario Five: Biological samples
Here it is essential to track exactly who is requesting the sample and for what purpose. Whilst various options on how to achieve this are possible, one solution would be to automatically deny use to all but a select few people, and at the same time notify all in the group when anyone approved does use the sample.
The main requirement for managing chemical and/or biological substance restrictions in inventory or LIMS software is the capability to either deny a request or initiate a negotiation where the final outcome will be to approve or deny the request.
In addition, in Titian’s experience, it is useful to have an option which keeps track of what is being requested but does not in itself prevent the item from being ordered.
Finally, Mosaic software allows users to limit or allocate a restricted sample, with approval only required if certain limits are exceeded. If a sample is limited, the restriction only applies if more than a certain amount is requested. If it is allocated, the restriction applies if the neat amount remaining would fall below a reserved amount as part of the order.
It is worth noting that Mosaic software allows other aspects sample management to be restricted by use of Access Control Lists, however these will discussed in a separate article.
In summary, Mosaic software is a useful tool that is flexible enough to help you deal with a range of different cases where restrictions are needed. It allows users to easily place restrictions either at the substance (Compound ID, Batch, Tissue Sample) or labware (tube or plate) level to meet a range of needs and it also ensures that all requests and authorisations are logged in an audit trail.
However, the whole topic of sample restrictions is more complex than can be described in a short blog, particularly when it concerns Controlled Substances. If you have questions, please get in touch with Titian for further information.
 The complexity of compliance in sample management: a review of key issues impacting small molecule and biological sample management in early drug discovery, 2019 : https://journals.sagepub.com/doi/10.1177/2472630318817735
More about Mosaic software:
See how our sample ordering process supports restrictions and an efficient workflow.
View our Resource Centre for videos and white papers.
In any case, consider talking to one of our Titian experts – there is a better way to manage your samples!