Business requirements Building a Smart Laboratory 2012 Table 1: Software categories based on GAMP 5[5]


Category 1 Infrastructure software • Established or commercially-available layered software including operating systems, databases, office applications, etc.


• Infrastructure software tools including antivirus, network management tools, etc.


Category 2 Firmware • Discontinued – firmware now treated as category 3, 4 or 5.


• Clash with USP <1058> over approach for Group B laboratory instruments: validate or qualify?


Category 3: Non-configured products • Off-the-shelf products that cannot be changed to match the business processes. • Can also include products are configurable, but only if the default configuration is used.


Category 4: Configured products


• Configured products provide standard interfaces and functions that enable configuration of the application to meet user-specific business processes.


• Configuration using a vendor supplied scripting language should be handled as custom components (category 5).


Category 5: Custom applications • These applications are developed to meet the specific needs of the regulated company.


• Implicitly includes internal application macros, LIMS scripting language customisations, VBA spreadsheet macros


• High inherent risk with this type of software.


work and adopt it as my own’) and also by an impartial witness (‘I have read and understood this work’).[7,8] Evidence in US patent interferences is


subject to the Federal Rules of Evidence. Tere are a number of important hurdles that need to be overcome, in particular the Hearsay Rule (by definition, if the author cannot be present, then the evidence is hearsay) and the Business Records Exception. Te Business Records Exception is an


exception to the hearsay rule that allows business records, such as a laboratory notebook, to be admitted as evidence if they can be demonstrated to be relevant, reliable and authentic. Te following criteria must be met: • Records must be kept in the ordinary course of business (e.g. a laboratory notebook);


• Te particular record at issue must be one that is regularly kept (e.g. a laboratory notebook page);


• Te record must be made by or from a knowledgeable source (e.g. trained scientists);


As a minimum, a LIMS could consist


of only category 4 soſtware, but in a GMP environment it will also contain at least one type of category 5 soſtware, the scripting language option for customisation. Tis mixed environment affects the life cycle and will lengthen the time for implementation of the system. Terefore, when at all possible, the lab should change the business process to match the LIMS to reduce implementation time and validation cost, which was discussed in the previous section.


GAMP software categories and system life cycle for a LIMS


To define the risk and amount of work that we need to do when validating a LIMS, we need to understand the categories of soſtware present. Once this is determined, the life cycle that is necessary to implement a LIMS can be defined.


System life cycle detail and documented evidence


Te life cycle and documented evidence discussed in this section is based upon the validation of a number of systems, but needs to be understood in the context of an


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organisation’s computer validation policies and procedures. Each organisation can have different approaches and terminology. Terefore, the terminology used here may be different to some organisations. However, what matters is the question of whether you performed the work described in each section rather than argued over the name of a specific document. Te key message is that you can


demonstrate that the system was developed under control and is validated. Te main documents needed for validation of a LIMS are presented in Table 2.


Patent-related issues


Te US patent system is based on ‘First to Invent’ and in order to help determine who was first to invent, most companies engaged in scientific research create and preserve evidence that they can use to defend their patents at a future date. Traditionally, this evidence has been in the form of the bound paper laboratory notebook. In a patent dispute, any inventor is


assumed to have an interest in the outcome of the case, so their testimony must be corroborated. Most organisations require these notebooks to be signed by the author (‘I have directed and/or performed this


• Te record must be made contemporaneously (e.g. at the time of the experiment);


• Te record must be accompanied by testimony by a custodian (e.g. company records manager). Any doubt about the admissibility of


electronic records was largely removed by this statement from the Official Gazette (10 March 1998)[9]


: ‘Admissibility of electronic records in


interferences: Pursuant to 37 CFR 1.671, electronic records are admissible as evidence in interferences before the Board of Patent Appeals and Interferences to the same extent that electronic records are admissible under the Federal Rules of Evidence. Te weight to be given any particular record necessarily must be determined on a case-by-case basis.’ In terms of admissibility, paper and


electronic records are therefore equivalent. Te judgment is made on the evidence, not the medium in which it is presented. However, it is important to understand the factors that impact upon the authenticity of electronic records and that in the adversarial nature of the courtroom, the opposing side will attempt to discredit the record, the record keeping system and the record keeping process. Te integrity of the system and the process used to create and preserve records are therefore paramount. However, a lot of organisations still


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