Regulatory and Statutory Documents for Computerised Systems used in Laboratories

The full statutory and regulatory recommendations for computerised systems are always printed and supplied with a LabDriver system. We can provide help for a laboratory to validate and document the installation of the LabDriver or LabComm systems.

Laboratories and Clinics working in the Clinical Trials environment have extremely demanding regulations to follow and adhere to. If you are not working in this environment you will almost certainly be subject to less onerous regulations. 

The key documents are:

UK - The Good Laboratory Practice Regulations” 2004 Statutory Instrument No 994

OECD – “The Application of the Principles of GLP to Computerised Systems” M 116 Paris 1995

– Food and Drug Administration (FDA) CRF 21 Part 11

EU – European Clinical Trial Directives 2001/20/EC 2001

The requirements and recommendations of the different authorities are similar. Most of the recommendations are good practice and include procedures that a laboratory should be following anyway. The requirements for Clinical Trials are much more stringent that those for laboratories involved in diagnostic (general testing) work.  The laboratory should not assume that it is compliant with the regulations of all authorities if it has only used the regulations of one specific authority.

The LabDriver glossary of terms can be referred to for help with specific terminology. The word system in this context is used to mean a computerised system and is defined as “a group of hardware components and associated software designed and assembled to perform a specific function or group of functions".

Many of the regulations or guidance were written more than a decade ago. In 1997 the FDA issued 21 CFR part 11, which provides criteria for acceptance by FDA of electronic records. This document was written to show how an electronic signature would be accepted by the FDA as being equivalent to a handwritten signatures written on paper. This is a very difficult task for a computerised system as it requires that all user actions are recorded and every change (save or commit action) on a database is recorded.

In order to be compliant with 21 CFR part 11 the laboratory needs to assign user names and implement the Esig and Qsig features which are embedded within the LabDriver LIMS system.

A summary of the regulatory requirements from the documents above, are shown below.

  • The data stored in a computerised system should be backed up regularly.
  • Users must enter a unique username and password in order to gain any access to the system and these passwords should be changed periodically.
  • Different users should belong to different groups with different access rights, depending on their experience and role in the laboratory
  • The electronic signature of the users should appear on screen, in the audit trails and on the laboratory reports.
  • The system should log users out after a period of inactivity.
  • The system should use electronic signatures to show which user entered data and the system should show the source of that data (eg manual entry or analyser).
  • The system should allow laboratory reports to be produced, clearly defining their status (final or interim) within that Laboratory Report.
  • An audit trail should include when the laboratory reports were printed, by whom and where (location & printer)
  • An audit trail should provide the entire history of a sample from the point that the sample was booked in to the time the sample was completed and the lab report was issued
  • The audit trail should include details of the latest approved results, as well as any previous versions of the results.
  • The computerised system should have a User Requirements Specification (URS) and System Requirement Specification providing details of the intended functions and use of that system
  • The computerised system should be validated (tested and checked) against the requirement of the users (URS)
  • A full audit trail should exist for the laboratory analysers that are interfaced and show the source and date and time the data was acquired
  • The raw data from the electronic analysers should be archived
  • The system should be capable of exporting data in configurable formats.
  • The users should have training records that are maintained by the Laboratory

The OECD further defines the key requirements and summarises.

"Where computerised systems are used to capture, process, report or store raw data electronically, system design should always provide for the retention of full audit trails to show all changes to the data without obscuring the original data. It should be possible to associate all changes to data with the persons making those changes by use of timed and dated (electronic) signatures. Reasons for change should be given and recorded."

The features listed above should be included in the Laboratory System or User Requirements Specification document and this document should be used as part of the validation plan. We can provide consultancy help for any laboratory that wants to validate its LIMS system.