1. Risk Management

GMP guidance recommends a risk assessment of computerised systems to consider patient safety, data integrity and product quality. PharmCD complies with the NHS Data Security and Protection Toolkit to certify that our systems are fit for purpose for processing NHS patient data, ensuring patient safety and data security. See our accreditation status. We recommend that you register a free PharmCD account to test if our product is of sufficient quality to surpass your current systems.

2. Personnel

We offer cooperation and support with ensuring that PharmCD helps you meet your requirements and improve efficiency within your organisation. You can contact us via email or telephone as required.

3. Suppliers and Service Providers

We can provide a Service Level Agreement to include clear statements of responsbility for your usage of PharmCD and any data and records that you choose to store within it. We also provide template Standard Operating Procedures outlining how to perform different operations within PharmCD, such as performing a balance check or destroying expired stock. If you have any questions or suggestions, please contact us and we'll be happy to help.

4. Validation

We recommend downloading and modifying our template SOPs to produce your own protocols and data flows that meet how your organisation operates. You can then register a free PharmCD account to test that our software meets your requirements and for validation testing.

5. Data

PharmCD doesn't currently integrate with any 3rd party computer systems. There is no legal requirement to transfer existing controlled drugs register entries when switching systems, so we would not recommend this. Please read our template SOPs for more guidance on how to get started with PharmCD by making registers.

6. Accuracy Checks

PharmCD has built-in accuracy checks on manually entered data, to help minimize the risk of errors. For example, when making an entry for stock entered out, a preview of the new balance is provided to ensure that this tallies with the expected running balance before committing the entry.

7. Data Storage

All data and records entered onto PharmCD is securely stored on our cloud-based servers in London, and encrypted back-ups are done at least daily. For more information on data storage, please contact us.

8. Printouts

Controlled drug registers within PharmCD can be exported as printable PDF documents; for further information, please read our template SOPs and register a free PharmCD account to test this functionality out.

9. Audit Trails

All entries made into PharmCD are attributable to a named user. Any edits or "deletions" (voiding) of entries are also attributed to the user who took that action, allowing for a clear and legible audit trail for all GMP-relevant changes.

10. Change and Configuration Management

As a web-based software, changes to your organisation's settings can be made by named users with sufficient administrative privileges only. We can assist you in ensuring that only those members of your team who are sufficiently authorised are able to make changes to your organisation's settings and setting up role-based access controls.

11. Periodic evaluation

We're happy to assist with your organisation's periodic evaluation of PharmCD and will provide any systems information that you might need. Please note that we update the list of available CDs within PharmCD on a weekly basis against the NHS Dictionary of Medicines and Devices.

12. Security

Each PharmCD user should have their own personal login. Users can be assigned different roles and levels of access to the CD registers. 2 Factor Authentication can be set up on request to prevent unauthorised off-site access to your PharmCD account.

13. Incident Management

Please consider reporting any incidents to us where we can confidentially support you in improving PharmCD to reduce the risk of future incidents. Where appropriate we will make changes to PharmCD or disseminate learnings and best practice to other PharmCD customers to improve the management of controlled drugs.

14. Electronic Signature

All controlled drugs record entries in PharmCD have an equivalent electronic signature associated with them: these are permanently linked to the respective record, and include the date and time that they were applied. They can have the same impact as hand-written signatures within the boundaries of your organisation.

15. Batch release

PharmCD does not have any functionality for batch release.

16. Business Continuity

In the unlikely event of significant unavailability of PharmCD, we would recommend a back-up of suitable paper CD registers, as well as SOPs covering business continuity.

17. Archiving

PharmCD registers can be downloaded and exported as PDF documents, which can either be archived locally or printed and stored. For more information, please see 8. Printouts.