Pharmacy Courses

Tips for Regulated Laboratories | Data Integrity

Are You Haunted by Hybrid Systems?

Hybrid systems are the worst possible solution to have in any regulated or unregulated laboratory.

The best definition of a hybrid system or approach is found in the WHO guidance on good data management practices:

This refers to the use of a computerized system in which there is a combination of original electronic records and paper records that comprise the total record set that should be reviewed and retained.

Ideally, hybrid chromatography data systems should be reconfigured and revalidated to work electronically with electronic signatures. 

The principles for this design should be:

  • Electronic data should be captured at source.
  • All work should be done electronically, with all calculations performed within the CDS and report being electronically signed.
  • Ideally, sample weights and analysis identities should be downloaded from a LIMS or equivalent application. As this process is validated, the only transcription error checks are for manually entered data.
  • Transfer of results to a LIMS or similar application should only be performed by a validated and automatic transfer.
  • Know where the data are stored, so that electronic records can be retrieved quickly when required (ideally, this should be on a secure and resilient drive on the network that is backed up regularly by the IT function).

The best approach is to have a CDS architecture, even for a single chromatograph, that has the networked solution for record security and backup database to manage records.

Though good documentation practice plays important role in pharmaceuticals industry, they don't take it seriously and ignore it. Hence most of the observations or nonconformity arise because of this. Therefore practicing and applying computerized systems that meets the requirements of laboratory activities is most essential and needed.

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