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Agaram Tech
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Enterprise Laboratory Information Management Software Solutions
Enterprise Laboratory Information Management Software Solutions

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#Data #Integrity #Concepts - USFDA /MHRA

How does FDA use the term 'backup' in 211.68(b)?

It is a true copy of the original data that is maintained in a secure environment consistent with the records retention period.

A true copy must include the metadata and be retained in the original format, provided that a documented system in place to verify and record the integrity of the copy.

Not backup copies that may be created during normal computer use and temporarily maintained for disaster recovery.

Typical backup systems will not be able to handle the “backup” requirements of FDA. You may need a specialized system like SDMS, which can capture the original data along with metadata and store it in a meaningful manner. This also means you should have functional capabilities for accessing the data based on metadata.
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#Data #Integrity #Concepts - USFDA /MHRA

Static vs. Dynamic Records

Static: fixed data document such as a paper record or an electronic image, temperature recording, humidity as RH%. These could be some examples of static record.

Dynamic: record format allows interaction between the user and the record content such as a chromatogram where the integration parameters can be modified.

While there could be static records in the cGMP environment. But the static records should also accompany the metadata. e.g. when temperature is recorded you would need the metadata like which room, date and time was the temperature recorded.

Dynamic records like chromatographic records are the real challenging ones. If you are using an instrument with a software that does not have versioning or audit trailing capability, this setup will definitely raise a question on the data’s integrity. If you vary a single parameter you can generate an integration output that is different from the previous one. This could be termed as testing to specification as per recent data integrity observations.

If you are able to setup a system that can monitor such changes to the dynamic data and its related metadata with version control, the system’s integrity will not be questionable. Take a look at our LogiLab SDMS to understand how your organization can minimize data integrity related risks.
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#Data #Integrity #Concepts - USFDA /MHRA

What is an “audit trail”?

It is a secure computer generated date/time stamped log of events that lead to the creation, modification, deletion of data. It should be easy to find out the chronological events like who did what when and why for a specific record.

Suggestion for systems that do not have audit trails is to capture the metadata while creating the record in a secure system. E.g. record the metadata when creating say a HPLC run (which instrument, method, integration parameters used, column, flow rate, solvents etc).Any reprocessing should include the appropriate metadata and a reason for reprocessing.

You need to have a system that can allow you to record metadata for your primary data along with audit trail of events that happened to the record. It will be Ideal to have a system that can capture the raw and metadata with version control.

System audit trails like user login, failed login attempts, locking of users from un-authorized access are a must for cGMP.

You need to have a system that has a system level audit trail as well.

CGMP-compliant record-keeping practicesprevent data from being lost or obscured.

You need to have a system that can protect your records from being lost, deleted or obscured and at the same time maintain the relationship between you data and metadata. Ordinary backup systems will not be able to handle such requirement.
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#Data #Integrity #Concepts - USFDA /MHRA

What is Metadata?

It is contextual data about the cGMP data or record. e.g. if you capture the weight of a substance using balance, metadata such as the following are to be associated with the data.

1. Data and time of capture with instrument ID. Who captured the data.
2. For which sample, batch, lot, product, test etc.
3. For a test you may have to capture several weights, so you may need to associate the metadata like sample-weight or standards-weight, weight of sample before drying etc.
4. For a batch record you may weigh the raw materials to be used for production. which product, raw material, batch etc are metadata.

You need to have a system that can associate the data with such metadata.
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A recent presentation on Data Integrity and cGMP from Sarah Barkow and Karen Takahashi of CDER. Link - goo.gl/8RgWXD
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Say No to papers! No to spreadsheets! Get your data captured with LogiLAB ELN and Go Green. Learn more- http://ow.ly/RCNl30388iv
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Document Management System
Struggling to manage your documents?
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To save time and effort, eliminate manual processes in your laboratory with a reliable software solution.
For more details, Visit:- https://www.agaramtech.com/
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#Enterprise #Laboratory #Information #Management #Software Solutions: #QuaLIS™ by Agaram Technologies
Visit: www.agaramtech.com to know more about our products and services.
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Say No to papers! No to spreadsheets! Get your data captured with LogiLAB ELN and Go Green. Learn more- http://ow.ly/RCNl30388iv
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