Building a Smart Laboratory 2012 Business requirements


time is taken up in managing the paper- based processes and to use this as a basis for potential time savings with an electronic solution. (see Figure 5). Although the start-up costs are high for an electronic solution, the incremental cost of adding new users and increasing storage space is modest. Return on investment (ROI) tends to focus


on the short term – how soon can we get a return on the money invested in deploying a new system – but the true value of the system may be long term and therefore far more difficult to measure since the value will be determined by behavioural changes. For example, there is a growing body of evidence being presented at conferences on electronic laboratory notebooks (ELN) by numerous companies that have implemented such a solution, showing that the short-term time savings are significant. In addition, each of these organisations lists a number of other non-quantifiable, long-term benefits: • Scientists can spend more time in the laboratory;


• It is easier to find information in a searchable archive;


• It is easier to share information; • Increased efficiency can be achieved through the elimination of paper;


• Tere is a reduced need to repeat experiments (knowingly or unknowingly);


• Data quality (legibility) is improved; • A smooth transition when people leave the company;


• Online use in meetings.


If you have an ROI process, get as much help as you can to find out how it works and how to make it work successfully. Consider ‘Cost vs. Value’ and think carefully about the hidden costs of paper.


Regulatory compliance and systems validation


Te FDA requirements for 21 CFR Part 11 compliance for most life science companies has been directed mainly in the area of development, manufacturing and clinical trials. 21CFR Part 11 outlines the criteria under which electronic records and electronic signatures are considered to be trustworthy, reliable and equivalent to paper records. Typically, research or discovery tend to be outside the direct reach of Part


“Any organisation considering the implementation of a new informatics or automation system will want to investigate the return on investment or cost/benefit”


11, but the principles of Part 11 compliance are closely related to legal requirements and it therefore makes good sense to take these into consideration for an ELN project. In this way, the fundamental principles


of the trustworthiness, reliability and authenticity of scientific evidence can be supported by a robust process that defines the course of the regularly conducted business activity used to create the evidence. Furthermore, should the ELN project be extended into development areas, then, of course, compliance will become mandatory. In order to meet regulatory requirements, the following criteria typically apply:


Fig. 5: System costs of paper notebooks and ELNs Paper Electronic Cost Elements


Media Storage


Management Process Number of users


• Te system must be validated; • Te system should produce human readable output;


• Te system should have security/access control;


• Te system should have an audit trail; • Te system should have version control; • Te system should have data validity checks;


• Te system should have provide an electronic signature process for all signed electronic records that includes: - Printed name of the signer; - Date and time of signature execution; - Meaning of signature;


• Establish corporate internal policies and guidelines for regulatory compliance: - Validation policy and procedures; - Disaster recovery; - Revision and change control procedures;


- System access and security procedures; - Training procedures; - Document control procedures;


• Develop a clear, comprehensive migration strategy: - Include records, signatures, audit trail;


• Establish retention policies based on current predicate rule requirements.


Regulatory compliance and systems validation is more common in the GxP environment and is applied to LIMS, SDMS and LES systems.


GAMP software categories in a LIMS


Te Good Automated Manufacturing Practice (GAMP) guidelines is an industry-written document for the validation of computerised systems used in the pharmaceutical industry now in its 5th version.[5]


In all versions


there is a classification of soſtware into one of five categories presented in Table 1. Further discussion and debate on the GAMP soſtware categories as applied to laboratory computerised systems can be found in the paper by McDowall.[6] A LIMS could therefore contain the


following categories of soſtware: • LIMS application soſtware which is configured (category 4);


• Customisation of the product using the internal scripting language (category 5);


• Writing custom code using a recognised computer language to connect the LIMS to another application or instrument (category 5).


17


System cost


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