Unrivalled Radiopharmaceutical Batch Reporting Capabilities in PETra
13th February 2018
The Batch Report is the key, central document in any radiopharmaceutical manufacturing facility. It is used to record and report all key data relating to batch release and is often heavily scrutinised.
The responsible person for producing the document is under significant pressure to ensure the batch record is accurate and is approved in a timely fashion.
When using a typical, paper-based system a number of issues can often arise. For example,
- Production and QC staff making hand-written entries or copying significant amounts of key batch data, can lead to time delays and increase the risk of transcription errors.
- Signatures relating to key process steps can be missing or wrongly-attributed,
- Approvals or operations can happen too early or out of sequence.
- Non-approved (unreleased) materials can be unwittingly used within the batch.
The impact of these issues can be wide-ranging and serious.
- Transcription errors and missing signatures are GMP non-compliances, commonly reported as serious quality assurance failures in Regulatory Compliance audits.
- Lengthy paper-based documents can cause confusion or delays, or can cause crucial information to be missed, leading to possible release of an unsafe or incomplete batch.
- Use of unapproved or expired materials is always considered an unacceptable risk to patient safety.
PETra, LabLogic’s PET-specific LIMS system provides a solution for removing unnecessary issues and reducing these risks.
- Direct data capture from equipment eliminates the risk of transcription errors.
- Electronic Signatures ensure no signature is ever missed and signing of the batch for release is quick and simple.
- Pre-configured methods, with step-by-step prompts ensure that only correct processes are followed in the correct sequence during a batch.
- Operator accountability is ensured through user-specific log-ins and comprehensive audit trails.
- Security levels can be established to ensure only qualified persons perform batch release.
- Inventory management ensures that only approved/released materials are used in a batch and that appropriate stock levels are maintained.
Not only does PETra help resolve the issues when collecting the data for the batch report, it also makes creating the batch report simple and hassle free.
- With all the relevant data in a secure, central repository the production of a batch report is available at the click of a button.
- Report templates can be easily customized to suit various reporting needs.
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