Laboratory Compliance

Laboratory Compliance

Regular audits can disrupt schedules and increase workloads, with the risk of failure leading to potential loss of reputation, business and personnel.

Whether you are trying to manage your human tissue act (HTA) audit, are looking to comply with the Good Laboratory Practice (GLP) guidelines or are looking for software to help assist in your 21 CFR Part 11 compliance, Achiever Medical includes tools to ensure full compliance.

We currently guide and assist the University of Leeds, Nottingham University Hospital Trust and the University of Leicester Bone Bank through their HTA audits.

Promote Compliance

Reduce the overhead of compliance with inbuilt processes to support standards

Reduce Effort & Costs

Minimise the cost and effort of reporting adherence for auditing purposes

Control Lab Standards

Changes to lab standards can be rolled out to system-based processes to ensure they are adapted

Key Features

Implementing Standard Operating Procedures (SOPs)

Achiever can help reduce the burden of compliance through implementing processes (such as Standard Operating Procedures)  within the software to ensure all users are completing the same tasks in a consistent manner, the appropriate data is updated at the right time, areas of non-compliance are highlighted through dashboards and notifications, users are notified when due dates are approaching and the appropriate approvals and documentation (such as consent forms and ethics approval documents) are in place.

 

Full Traceability of Information

Providing comprehensive sample identification and profiling information for each sample registered including its source, reason for registration, details of processing carried out, storage location history, usage and current status is crucial for any audit.  Achiever prompts users to capture critical information at the appropriate times in the process and provides detailed field and record level auditing functionality for complete traceability.

 

Documentation and Consent

In-built document management capability enables informed consent forms, ethics approval documentation and material/tissue transfer agreements to be stored and registered within the solution with dashboards and automated email alerts highlighting areas of non-compliance or missing information.  Data protection rules prevent unauthorised users from accessing and opening sensitive documentation as appropriate.

 

Reporting and Analysis

In addition, reports and analysis providing real-time data, can be run at the touch of a button instead of valuable laboratory personnel spending days (sometimes weeks) painstakingly collating information from various spreadsheets.

SEE WHAT OUR CUSTOMERS SAY

“The NUHT biobank team then went through a full HTA audit within three days of go-live and received a glowing HTA assessment.

The quality of the donor, consent, storage and tissue viability data massively increases the value of the tissues to researchers.”