Explore compliance and Precisa balances

What is GxP and CFR21 part 11 compliance?

Good practice (GxP) refers to a set of quality guidelines and regulations to ensure consistency, reliability and uniformity within various disciplines. The most common subcategories included are:

Good laboratory practice (GLP)

Good clinical practice (GCP)

Good manufacturing practice (GMP)

CFR21 part 11 compliance is a set of rules outlined by the USA to ensure that drug manufacturers and other relevant companies comply to the same standards. This set of guidelines is aimed at providing guidance towards electronic documentation in laboratories and similarly controlled companies, but is still a standard that paper-based companies can adhere to.

Why are GxP and CFR21 part 11 compliances important?

To ensure that no fraudulent practices are occurring that could prevent the generation of reliable and accurate data or products. Additionally it is also to ensure that all relevant companies adhere to the same quality standard, and that any code violations are detected and prevented in order to produce quality drug products that are safe and efficient.

How do Techcomp Lab products by Precisa balances meet compliance requirements?

Various features have been implemented to ensure GxP compliance within your laboratory.

Suitable: The weighing system you are using should be suitable. This means that you use a balance which is within the range of what you are weighing. Whilst it is the user’s responsibility to check that the balance they are using is suitable, in order to provide an extra security measure, Techcomp developed the minimum sample weight (MSW) feature. This ensures that the sample you are weighing is above the minimum required sample weight according to the US Pharmacopeia, meaning that your weighing results will have statistical relevance. The Series 390 and 520PT balances contain the MSW features integrated, and so will inform the user the minimum weight required on the weighing pan to meet these requirements.

Calibrated and levelled: The balance should only be used when it has been calibrated and levelled: if the balance is used when it has not met this criteria, then the results generated will be inaccurate. This is why the Series 390 and 520PT balances provide the user with a visual warning when the balance is not level, to ensure that you are only ever receiving accurate and reliable weighing results. Calibration occurs at the touch of a button, and levelling is simplified, with the balance informing the user which way to turn the feet to be levelled.

User-specific profiles: Any data generated should be attributable, and state clearly who performed the action and when. In order to achieve this electronically, balances should have user specific profiles. These user profiles come with the ability to individually set access rights. Access depth is defined, with access to special settings either locked or unlocked depending on the requirement. For the Series 390 and 520PT balances, you are able to store 15 different password protected user profiles.

Alibi memory and audit trail: A key component of compliance includes data management and modifications, which means having a permanent, tamper-protected, time-stamped log of all events – this is also vital for both CFR and GxP compliance. The general rule is, if it is not documented then you cannot prove it happened. Therefore, having an electronic log that allows the reconstruction of events related to the creation, modification or deletion of data means that you will always be able to prove what happened and when. To achieve this digitally, balances should have an audit trail. Additionally, alibi memory software stores all weighing results. These systems complement each other to ensure data integrity, which can also be exported onto a USB, ensuring safe data transfer which cannot be tampered with.

Signature: It is essential for data to be attributable. With the Series 390 and 520PT balances, a printout of results will include the username of the individual. Additionally, balances which contain an audit trail allow for the traceability of all data digitally, with the audit trail correlating with the username of the individual. Alternatively, you can print off your balance results, which allows the user to sign the relevant documents by hand for other series of balances such as the 360. Both of these methods allow for your data to be attributable and the balance can adapt to your laboratories requirements, depending on whether or not you require a signature digitally or on paper.

Which balance is best for me to ensure GxP / CFR compliance?

This is dependent on your laboratory’s needs and application, and whether or not you require full digital compliance.

The Series 390 and Series 520PT balances

To ensure complete digital compliance with GxP standards, the Series 390 or 520PT balances are the ideal choice, due to their advanced features, which includes:

• User defined profiles – ensures accountability for all measurements
• Integrated audit trail – allows for traceability of data that has been generated, changed or deleted
• Alibi memory – ensures data integrity through storing of weighing results

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