Building a Smart Laboratory 2017

is to test each function separately. Tis is oſten what the supplier already has done, so the user may not have to do this if documentation and/or a supplier audit has shown that this has been done.

PQ – Performance or process qualification Te PQ is also defined differently in different organisations. Basically, the PQ is testing that the implemented system is according to business processes. Tis includes indirectly testing that the separate functions work as intended. Tis may also be called the system testing.

If the supplier’s OQ testing is unavailable, more of the functions may have to be included in testing. It is perfectly fine to combine the OQ and PQ into one combined phase. It is important to qualify or validate all the

functions needed for your workflows. A thorough description of IT validation

can be found in the book, International IT Regulations and Compliance. Tis book also has chapters on LIMS and instrument systems, and the tips there are useful to read and follow in order to get a really smart laboratory with the information required. But validation is never done. It’s important

to prove that the system is still validated, even aſter changes in and around the system. Having appropriate procedures to explain how to keep the validated state, and documentation to prove that procedures have been followed, are a must. Tese procedures need to cover whatever

is appropriate, including: l Error handling, including corrective action and preventive action;

l Change management; l Validation/qualification of changes; l Backup and recovery; l Configuration management; l Disaster recovery and business continuity; l E-signatures; l Environmental conditions; l Risk assessment and management; l Security and user access; l Service level agreements; l System description; l Training; l Validation and qualification; l Supplier audit; l Daily use; l Implementation of data in the system; l Qualification/validation of implemented data in the system; and

l Data transfer between systems.

Some of these SOPs will be generic in the organisation, and some will be system specific. Validation is a never-ending job, but with a

validated system the user can be sure that the system works as intended and that the data is secured inside the system. Tat means that the user can prove beyond doubt that the data was entered on a given date and that the system will show that data has been corrected later.

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

“Data integrity, in a general sense, means that data cannot be created, changed, or deleted without authorisation”

be corroborated. Most organisations require these notebooks to be signed by the author (‘I have directed and/or performed this work and adopt it as my own’) and also by an impartial witness (‘I have read and understood this work’).[10, 11] 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, which 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: l Records must be kept in the ordinary course of business (e.g. a laboratory notebook);

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

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

Beyond the laboratory

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

l 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 [12]


‘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 may 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. Many organisations still require their

scientists to keep bound laboratory notebooks. Tis is because there isn’t the case law or other experience for most legal advisors to feel as comfortable with electronic records as they are with paper. Te issue is not one of admissibility, but of the weight that the record will have in court. Unfortunately, we are unlikely to see a suitable body of case law for many years. Te high-stakes nature of the problem,

lack of experience, and long-term accessibility concerns have caused a number of organisations to adopt a hybrid solution, using an electronic lab notebook (ELN) front-end tool to create records, and then preserving the resulting records on paper. Tis gives the benefits of paper records (for the lawyers) while providing the scientists with the benefit of new tools. A fully electronic system will require scientists to sign documents electronically, and the resulting record to be preserved electronically. Using multiple systems for patent evidence

creation and preservation can expose an organisation to increased risk, due to the need to maintain the integrity of each system, and the consistency of the content between them.


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