Building a Smart Laboratory 2012 Technical issues


Tis is an issue that every electronic records initiative has to face, regardless of scope or scale. Whether it is government records, medical records, scientific records or a personal collection of digital photographs, the problem is the same; what do we have to do to ensure that we can still access these records in 50 years’ time, or more? Te track record of the IT industry in addressing long-term data preservation is not good; proprietary data formats, content tied to the application, lack of integration standards, unreliable media and a lack of a stable operating system environment all conspire to produce a major challenge in switching to electronic records. For laboratory informatics, there are two


major factors to take into consideration to guarantee the long-term preservation of records: data formats and electronic records management.


Data formats


Currently the most common solution for electronic laboratory notebooks (ELNs) is to render completed experiment documents as PDF or PDF/A files for long-term record keeping. Te Portable Document Format (PDF), created by Adobe Systems, has evolved into an international standard (ISO 32000) for rendering documents in a fixed layout that is device-independent. PDF/A is a standard for the long-term archiving of electronic documents and is also an ISO standard (ISO 19005-1:2005). It is a subset of PDF, leaving out features not suited to long-term archiving. Te use of PDF or PDF/A is generally


considered to be the best option for the preservation of documents for IP and legal purposes, but the long-term storage of lab data is a different matter. Te biggest problem by far is proprietary data formats. Most laboratory instruments are not designed with long-term record keeping considerations in mind and generate data in proprietary


Quality criteria


Internal use


Regulatory 21CFR part 11


Patents Internal requirements


Published regulations, with comment


Case law,


Federal Rules of evidence, etc.


formats. In some markets, this situation is being progressively addressed by means of open platforms that provide data interchange and systems’ integration standards. In the clinical world there is good progress, driven by the demand of health records. Unfortunately, the laboratory world does not have an equivalent driver. For this reason, it becomes important to


establish not only how the laboratory records are managed, but also how data files are stored and where. Although most commercial ELNs will accommodate data files in the ELN database, best practice is generally to store data in a separate repository, possibly an SDMS, with appropriate links, and to include appropriate graphical representation of the data in the ELN; basically the electronic equivalent of pasting in selected graphical instrument output into a paper lab notebook. In this way, the ELN contains sufficient


information to support the conclusions of the experiment and to allow the experiment to be repeated, but eliminates the need to manage disparate proprietary data within the ELN system. Where data resides outside of the ELN, links to this data can be made from within the ELN, but it will be necessary to take into consideration how this data and the links are managed over the long term through new revisions of soſtware.


Electronic records management


Long-term data preservation raises the question whether the records should be stored in the ELN, or whether they are transmitted to a separate records management system, leaving the ELN to serve mainly as an operational system. For large companies, records management is typically a broader organisational process, managed by specialists, and ELNs oſten need to be integrated with an existing records management system. For smaller companies, it will be an essential


Material to be preserved Scrutiny


Scientific data and experimental write up


Primarily scientific data. Some write up


Primarily experimental write up. Some data


Little, if any


Regulatory inspection


Adversarial


decision in the implementation project to determine just how ELN records will be managed over the long-term. Basic records management guidelines are


as follows: • Integrate electronic content/records management;


• Understand the legal implications of electronic records;


• Establish a file plan; • Establish an electronic records preservation file plan;


• Establish a records management team; • Train the technical team; • Establish and communicate policies; • Avoid point solutions; • Don’t keep electronic records forever. General requirements for electronic


records are summarised in the table below.


Systems integration Prior to around 1900, most scientific innovation and development was either embedded in an industrial process or was an outcome of academic or privately-initiated research. Te progressive introduction of industrial research and development labs heralded a new era of innovation and development with an extensive dependence on the skills, knowledge and creativity of individual scientists. Te evolution has continued into the ‘information age’ with a growing dependence on information technology as both an integral part of the scientific process and as a means of managing scientific information and knowledge. From the basic application of


computational power to undertake scientific calculations at unprecedented speeds, to the current situation of extensive and sophisticated laboratory automation, black box measurement devices and multiuser information management systems, technology is causing glassware and paper notebooks to


Timescale Company defined Defined by regulations


~ 10 years before first come under scrutiny. Retain for 50 to100 years


Format


XML, De Facto standards, ad hoc


XML, De Facto standards PDF (paper, microfilm)


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