Gutmann method

Gutmann method

The Gutmann method is an algorithm for securely erasing the contents of computer hard disk drives, such as files. Devised by Peter Gutmann and Colin Plumb and presented in the paper Secure Deletion of Data from Magnetic and Solid-State Memory in July 1996, it involved writing a series of 35 patterns over the region to be erased. The selection of patterns assumes that the user does not know the encoding mechanism used by the drive, so it includes patterns designed specifically for three types of drives. A user who knows which type of encoding the drive uses can choose only those patterns intended for their drive. A drive with a different encoding mechanism would need different patterns. Most of the patterns in the Gutmann method were designed for older MFM/RLL-encoded disks. Gutmann himself has noted that more modern drives no longer use these older encoding techniques, making parts of the method irrelevant. He said "In the time since this paper was published, some people have treated the 35-pass overwrite technique described in it more as a kind of voodoo incantation to banish evil spirits than the result of a technical analysis of drive encoding techniques". Since about 2001, some ATA IDE and SATA hard drive manufacturer designs include support for the ATA Secure Erase standard, obviating the need to apply the Gutmann method when erasing an entire drive. The Gutmann method does not apply to USB sticks: a 2011 study reports that 71.7% of data remained available. On solid state drives it resulted in 0.8–4.3% recovery. == Background == The delete function in most operating systems simply marks the space occupied by the file as reusable (removes the pointer to the file) without immediately removing any of its contents. At this point the file can be fairly easily recovered by numerous recovery applications. However, once the space is overwritten with other data, there is no known way to use software to recover it. It cannot be done with software alone since the storage device only returns its current contents via its normal interface. Gutmann claims that intelligence agencies have sophisticated tools, including magnetic force microscopes, which together with image analysis, can detect the previous values of bits on the affected area of the media (for example hard disk). This claim however seems to be invalid based on the thesis "Data Reconstruction from a Hard Disk Drive using Magnetic Force Microscopy". == Method == An overwrite session consists of a lead-in of four random write patterns, followed by patterns 5 to 31 (see rows of table below), executed in a random order, and a lead-out of four more random patterns. Each of patterns 5 to 31 was designed with a specific magnetic media encoding scheme in mind, which each pattern targets. The drive is written to for all the passes even though the table below only shows the bit patterns for the passes that are specifically targeted at each encoding scheme. The result should obscure any data on the drive so that only the most advanced physical scanning (e.g., using a magnetic force microscope) of the drive is likely to be able to recover any data. The series of patterns is as follows: Encoded bits shown in bold are what should be present in the ideal pattern, although due to the encoding the complementary bit is actually present at the start of the track. == Criticism == Daniel Feenberg of the National Bureau of Economic Research, an American private nonprofit research organization, criticized Gutmann's claim that intelligence agencies are likely to be able to read overwritten data, citing a lack of evidence for such claims. He finds that Gutmann cites one non-existent source and sources that do not actually demonstrate recovery, only partially-successful observations. The definition of "random" is also quite different from the usual one used: Gutmann expects the use of pseudorandom data with sequences known to the recovering side, not an unpredictable one such as a cryptographically secure pseudorandom number generator. Nevertheless, some published government security procedures consider an overwritten disk to still be sensitive. Human factors and potential limitations in the overwriting software create a residual risk that is not considered acceptable at the highest security levels. Gutmann himself has responded to some of these criticisms and also criticized how his algorithm has been abused in an epilogue to his original paper, in which he states: In the time since this paper was published, some people have treated the 35-pass overwrite technique described in it more as a kind of voodoo incantation to banish evil spirits than the result of a technical analysis of drive encoding techniques. As a result, they advocate applying the voodoo to PRML and EPRML drives even though it will have no more effect than a simple scrubbing with random data. In fact performing the full 35-pass overwrite is pointless for any drive since it targets a blend of scenarios involving all types of (normally-used) encoding technology, which covers everything back to 30+-year-old MFM methods (if you don't understand that statement, re-read the paper). If you're using a drive which uses encoding technology X, you only need to perform the passes specific to X, and you never need to perform all 35 passes. For any modern PRML/EPRML drive, a few passes of random scrubbing is the best you can do. As the paper says, "A good scrubbing with random data will do about as well as can be expected". This was true in 1996, and is still true now. Gutmann's statement has been criticized for not recognizing that PRML/EPRML does not replace RLL, with critics claiming PRML/EPRML to be a signal detection method rather than a data encoding method. Polish data recovery service Kaleron has also claimed that Gutmann's publication contains further factual errors and assumptions that do not apply to actual disks.

Information extraction

Information extraction (IE) is the task of automatically extracting structured information from unstructured and/or semi-structured machine-readable documents and other electronically represented sources. Typically, this involves processing human language texts by means of natural language processing (NLP). Recent activities in multimedia document processing like automatic annotation and content extraction out of images/audio/video/documents could be seen as information extraction. Recent advances in NLP techniques have allowed for significantly improved performance compared to previous years. An example is the extraction from newswire reports of corporate mergers, such as denoted by the formal relation: MergerBetween ⁡ ( c o m p a n y 1 , c o m p a n y 2 , d a t e ) {\displaystyle \operatorname {MergerBetween} (\mathrm {company} _{1},\mathrm {company} _{2},\mathrm {date} )} , from an online news sentence such as: "Yesterday, New York based Foo Inc. announced their acquisition of Bar Corp." A broad goal of IE is to allow computation to be done on the previously unstructured data. A more specific goal is to allow automated reasoning about the logical form of the input data. Structured data is semantically well-defined data from a chosen target domain, interpreted with respect to category and context. Information extraction is the part of a greater puzzle which deals with the problem of devising automatic methods for text management, beyond its transmission, storage and display. The discipline of information retrieval (IR) has developed automatic methods, typically of a statistical flavor, for indexing large document collections and classifying documents. Another complementary approach is that of natural language processing (NLP) which has solved the problem of modelling human language processing with considerable success when taking into account the magnitude of the task. In terms of both difficulty and emphasis, IE deals with tasks in between both IR and NLP. In terms of input, IE assumes the existence of a set of documents in which each document follows a template, i.e. describes one or more entities or events in a manner that is similar to those in other documents but differing in the details. An example, consider a group of newswire articles on Latin American terrorism with each article presumed to be based upon one or more terroristic acts. We also define for any given IE task a template, which is a(or a set of) case frame(s) to hold the information contained in a single document. For the terrorism example, a template would have slots corresponding to the perpetrator, victim, and weapon of the terroristic act, and the date on which the event happened. An IE system for this problem is required to "understand" an attack article only enough to find data corresponding to the slots in this template. == History == Information extraction dates back to the late 1970s in the early days of NLP. An early commercial system from the mid-1980s was JASPER built for Reuters by the Carnegie Group Inc with the aim of providing real-time financial news to financial traders. Beginning in 1987, IE was spurred by a series of Message Understanding Conferences. MUC is a competition-based conference that focused on the following domains: MUC-1 (1987), MUC-3 (1989): Naval operations messages. MUC-3 (1991), MUC-4 (1992): Terrorism in Latin American countries. MUC-5 (1993): Joint ventures and microelectronics domain. MUC-6 (1995): News articles on management changes. MUC-7 (1998): Satellite launch reports. Considerable support came from the U.S. Defense Advanced Research Projects Agency (DARPA), who wished to automate mundane tasks performed by government analysts, such as scanning newspapers for possible links to terrorism. == Present significance == The present significance of IE pertains to the growing amount of information available in unstructured form. Tim Berners-Lee, inventor of the World Wide Web, refers to the existing Internet as the web of documents and advocates that more of the content be made available as a web of data. Until this transpires, the web largely consists of unstructured documents lacking semantic metadata. Knowledge contained within these documents can be made more accessible for machine processing by means of transformation into relational form, or by marking-up with XML tags. An intelligent agent monitoring a news data feed requires IE to transform unstructured data into something that can be reasoned with. A typical application of IE is to scan a set of documents written in a natural language and populate a database with the information extracted. == Tasks and subtasks == Applying information extraction to text is linked to the problem of text simplification in order to create a structured view of the information present in free text. The overall goal being to create a more easily machine-readable text to process the sentences. Typical IE tasks and subtasks include: Template filling: Extracting a fixed set of fields from a document, e.g. extract perpetrators, victims, time, etc. from a newspaper article about a terrorist attack. Event extraction: Given an input document, output zero or more event templates. For instance, a newspaper article might describe multiple terrorist attacks. Knowledge Base Population: Fill a database of facts given a set of documents. Typically the database is in the form of triplets, (entity 1, relation, entity 2), e.g. (Barack Obama, Spouse, Michelle Obama) Named entity recognition: recognition of known entity names (for people and organizations), place names, temporal expressions, and certain types of numerical expressions, by employing existing knowledge of the domain or information extracted from other sentences. Typically the recognition task involves assigning a unique identifier to the extracted entity. A simpler task is named entity detection, which aims at detecting entities without having any existing knowledge about the entity instances. For example, in processing the sentence "M. Smith likes fishing", named entity detection would denote detecting that the phrase "M. Smith" does refer to a person, but without necessarily having (or using) any knowledge about a certain M. Smith who is (or, "might be") the specific person whom that sentence is talking about. Coreference resolution: detection of coreference and anaphoric links between text entities. In IE tasks, this is typically restricted to finding links between previously extracted named entities. For example, "International Business Machines" and "IBM" refer to the same real-world entity. If we take the two sentences "M. Smith likes fishing. But he doesn't like biking", it would be beneficial to detect that "he" is referring to the previously detected person "M. Smith". Relationship extraction: identification of relations between entities, such as: PERSON works for ORGANIZATION (extracted from the sentence "Bill works for IBM.") PERSON located in LOCATION (extracted from the sentence "Bill is in France.") Semi-structured information extraction which may refer to any IE that tries to restore some kind of information structure that has been lost through publication, such as: Table extraction: finding and extracting tables from documents. Table information extraction : extracting information in structured manner from the tables. This task is more complex than table extraction, as table extraction is only the first step, while understanding the roles of the cells, rows, columns, linking the information inside the table and understanding the information presented in the table are additional tasks necessary for table information extraction. Comments extraction : extracting comments from the actual content of articles in order to restore the link between authors of each of the sentences Language and vocabulary analysis Terminology extraction: finding the relevant terms for a given corpus Audio extraction Template-based music extraction: finding relevant characteristic in an audio signal taken from a given repertoire; for instance time indexes of occurrences of percussive sounds can be extracted in order to represent the essential rhythmic component of a music piece. Note that this list is not exhaustive and that the exact meaning of IE activities is not commonly accepted and that many approaches combine multiple sub-tasks of IE in order to achieve a wider goal. Machine learning, statistical analysis and/or natural language processing are often used in IE. IE on non-text documents is becoming an increasingly interesting topic in research, and information extracted from multimedia documents can now be expressed in a high level structure as it is done on text. This naturally leads to the fusion of extracted information from multiple kinds of documents and sources. == World Wide Web applications == IE has been the focus of the MUC conferences. The proliferation of the Web, however, intensified the need for developing IE systems that help people

Radical trust

Radical trust is the confidence that any structured organization, such as a government, library, business, religion, or museum, has in collaboration and empowerment within online communities. Specifically, it pertains to the use of blogs, wiki and online social networking platforms by organizations to cultivate relationships with an online community that then can provide feedback and direction for the organization's interest. The organization 'trusts' and uses that input in its management. One of the first appearances of the notion of radical trust appears in an info graphic outlining the base principles of web 2.0 in Tim O'Reilly's weblog post "What is Web 2.0". Radical Trust is listed as the guiding example of trusting the validity of consumer generated media. This concept is considered to be an underlying assumption of Library 2.0. The adoption of radical trust by a library would require its management let go of some of its control over the library and building an organization without an end result in mind. The direction a library would take would be based on input provided by people through online communities. These changes in the organization may merely be anecdotal in nature, making this method of organization management dramatically distinct from data-based or evidence based management. In marketing, Collin Douma further describes the notion of radical trust as a key mindset required for marketers and advertisers to enter the social media marketing space. Conventional marketing dictates and maintains control of messages to cause the greatest persuasion in consumer decisions, but Douma argued that in the social media space, brands would need to cede that control in order to build brand loyalty.

Format-transforming encryption

In cryptography, format-transforming encryption (FTE) refers to encryption where the format of the input plaintext and output ciphertext are configurable. Descriptions of formats can vary, but are typically compact set descriptors, such as a regular expression. Format-transforming encryption is closely related to, and a generalization of, format-preserving encryption. == Applications of FTE == === Restricted fields or formats === Similar to format-preserving encryption, FTE can be used to control the format of ciphertexts. The canonical example is a credit card number, such as 1234567812345670 (16 bytes long, digits only). However, FTE does not enforce that the input format must be the same as the output format. === Censorship circumvention === FTE is used by the Tor Project to circumvent deep packet inspection by pretending to be some other protocols. The implementation is fteproxy; it was written by the authors who came up with the FTE concept.

Cryptovirology

Cryptovirology refers to the study of cryptography use in malware, such as ransomware and asymmetric backdoors. Traditionally, cryptography and its applications are defensive in nature, and provide privacy, authentication, and security to users. Cryptovirology employs a twist on cryptography, showing that it can also be used offensively. It can be used to mount extortion based attacks that cause loss of access to information, loss of confidentiality, and information leakage, tasks which cryptography typically prevents. The field was born with the observation that public-key cryptography can be used to break the symmetry between what an antivirus analyst sees regarding malware and what the attacker sees. The antivirus analyst sees a public key contained in the malware, whereas the attacker sees the public key contained in the malware as well as the corresponding private key (outside the malware) since the attacker created the key pair for the attack. The public key allows the malware to perform trapdoor one-way operations on the victim's computer that only the attacker can undo. == Overview == The field encompasses covert malware attacks in which the attacker securely steals private information such as symmetric keys, private keys, PRNG state, and the victim's data. Examples of such covert attacks are asymmetric backdoors. An asymmetric backdoor is a backdoor (e.g., in a cryptosystem) that can be used only by the attacker, even after it is found. This contrasts with the traditional backdoor that is symmetric, i.e., anyone that finds it can use it. Kleptography, a subfield of cryptovirology, is the study of asymmetric backdoors in key generation algorithms, digital signature algorithms, key exchanges, pseudorandom number generators, encryption algorithms, and other cryptographic algorithms. The NIST Dual EC DRBG random bit generator has an asymmetric backdoor in it. The EC-DRBG algorithm utilizes the discrete-log kleptogram from kleptography, which by definition makes the EC-DRBG a cryptotrojan. Like ransomware, the EC-DRBG cryptotrojan contains and uses the attacker's public key to attack the host system. The cryptographer Ari Juels indicated that NSA effectively orchestrated a kleptographic attack on users of the Dual EC DRBG pseudorandom number generation algorithm and that, although security professionals and developers have been testing and implementing kleptographic attacks since 1996, "you would be hard-pressed to find one in actual use until now." Due to public outcry about this cryptovirology attack, NIST rescinded the EC-DRBG algorithm from the NIST SP 800-90 standard. Covert information leakage attacks carried out by cryptoviruses, cryptotrojans, and cryptoworms that, by definition, contain and use the public key of the attacker is a major theme in cryptovirology. In "deniable password snatching," a cryptovirus installs a cryptotrojan that asymmetrically encrypts host data and covertly broadcasts it. This makes it available to everyone, noticeable by no one (except the attacker), and only decipherable by the attacker. An attacker caught installing the cryptotrojan claims to be a virus victim. An attacker observed receiving the covert asymmetric broadcast is one of the thousands, if not millions of receivers, and exhibits no identifying information whatsoever. The cryptovirology attack achieves "end-to-end deniability." It is a covert asymmetric broadcast of the victim's data. Cryptovirology also encompasses the use of private information retrieval (PIR) to allow cryptoviruses to search for and steal host data without revealing the data searched for even when the cryptotrojan is under constant surveillance. By definition, such a cryptovirus carries within its own coding sequence the query of the attacker and the necessary PIR logic to apply the query to host systems. == History == The first cryptovirology attack and discussion of the concept was by Adam L. Young and Moti Yung, at the time called "cryptoviral extortion" and it was presented at the 1996 IEEE Security & Privacy conference. In this attack, a cryptovirus, cryptoworm, or cryptotrojan contains the public key of the attacker and hybrid encrypts the victim's files. The malware prompts the user to send the asymmetric ciphertext to the attacker who will decipher it and return the symmetric decryption key it contains for a fee. The victim needs the symmetric key to decrypt the encrypted files if there is no way to recover the original files (e.g., from backups). The 1996 IEEE paper predicted that cryptoviral extortion attackers would one day demand e-money, long before Bitcoin even existed. Many years later, the media relabeled cryptoviral extortion as ransomware. In 2016, cryptovirology attacks on healthcare providers reached epidemic levels, prompting the U.S. Department of Health and Human Services to issue a Fact Sheet on Ransomware and HIPAA. The fact sheet states that when electronic protected health information is encrypted by ransomware, a breach has occurred, and the attack therefore constitutes a disclosure that is not permitted under HIPAA, the rationale being that an adversary has taken control of the information. Sensitive data might never leave the victim organization, but the break-in may have allowed data to be sent out undetected. California enacted a law that defines the introduction of ransomware into a computer system with the intent of extortion as being against the law. == Examples == === Tremor virus === While viruses in the wild have used cryptography in the past, the only purpose of such usage of cryptography was to avoid detection by antivirus software. For example, the tremor virus used polymorphism as a defensive technique in an attempt to avoid detection by anti-virus software. Though cryptography does assist in such cases to enhance the longevity of a virus, the capabilities of cryptography are not used in the payload. The One-half virus was amongst the first viruses known to have encrypted affected files. === Tro_Ransom.A virus === An example of a virus that informs the owner of the infected machine to pay a ransom is the virus nicknamed Tro_Ransom.A. This virus asks the owner of the infected machine to send $10.99 to a given account through Western Union. Virus.Win32.Gpcode.ag is a classic cryptovirus. This virus partially uses a version of 660-bit RSA and encrypts files with many different extensions. It instructs the owner of the machine to email a given mail ID if the owner desires the decryptor. If contacted by email, the user will be asked to pay a certain amount as ransom in return for the decryptor. === CAPI === It has been demonstrated that using just 8 different calls to Microsoft's Cryptographic API (CAPI), a cryptovirus can satisfy all its encryption needs. == Other uses of cryptography-enabled malware == Apart from cryptoviral extortion, there are other potential uses of cryptoviruses, such as deniable password snatching, cryptocounters, private information retrieval, and in secure communication between different instances of a distributed cryptovirus.

View model

A view model or viewpoints framework in systems engineering, software engineering, and enterprise engineering is a framework which defines a coherent set of views to be used in the construction of a system architecture, software architecture, or enterprise architecture. A view is a representation of the whole system from the perspective of a related set of concerns. Since the early 1990s there have been a number of efforts to prescribe approaches for describing and analyzing system architectures. A result of these efforts have been to define a set of views (or viewpoints). They are sometimes referred to as architecture frameworks or enterprise architecture frameworks, but are usually called "view models". Usually a view is a work product that presents specific architecture data for a given system. However, the same term is sometimes used to refer to a view definition, including the particular viewpoint and the corresponding guidance that defines each concrete view. The term view model is related to view definitions. == Overview == The purpose of views and viewpoints is to enable humans to comprehend very complex systems, to organize the elements of the problem and the solution around domains of expertise and to separate concerns. In the engineering of physically intensive systems, viewpoints often correspond to capabilities and responsibilities within the engineering organization. Most complex system specifications are so extensive that no single individual can fully comprehend all aspects of the specifications. Furthermore, we all have different interests in a given system and different reasons for examining the system's specifications. A business executive will ask different questions of a system make-up than would a system implementer. The concept of viewpoints framework, therefore, is to provide separate viewpoints into the specification of a given complex system in order to facilitate communication with the stakeholders. Each viewpoint satisfies an audience with interest in a particular set of aspects of the system. Each viewpoint may use a specific viewpoint language that optimizes the vocabulary and presentation for the audience of that viewpoint. Viewpoint modeling has become an effective approach for dealing with the inherent complexity of large distributed systems. Architecture description practices, as described in IEEE Std 1471-2000, utilize multiple views to address several areas of concerns, each one focusing on a specific aspect of the system. Examples of architecture frameworks using multiple views include Kruchten's "4+1" view model, the Zachman Framework, TOGAF, DoDAF, and RM-ODP. == History == In the 1970s, methods began to appear in software engineering for modeling with multiple views. Douglas T. Ross and K.E. Schoman in 1977 introduce the constructs context, viewpoint, and vantage point to organize the modeling process in systems requirements definition. According to Ross and Schoman, a viewpoint "makes clear what aspects are considered relevant to achieving ... the overall purpose [of the model]" and determines How do we look at [a subject being modelled]? As examples of viewpoints, the paper offers: Technical, Operational and Economic viewpoints. In 1992, Anthony Finkelstein and others published a very important paper on viewpoints. In that work: "A viewpoint can be thought of as a combination of the idea of an “actor”, “knowledge source”, “role” or “agent” in the development process and the idea of a “view” or “perspective” which an actor maintains." An important idea in this paper was to distinguish "a representation style, the scheme and notation by which the viewpoint expresses what it can see" and "a specification, the statements expressed in the viewpoint's style describing particular domains". Subsequent work, such as IEEE 1471, preserved this distinction by utilizing two separate terms: viewpoint and view, respectively. Since the early 1990s there have been a number of efforts to codify approaches for describing and analyzing system architectures. These are often termed architecture frameworks or sometimes viewpoint sets. Many of these have been funded by the United States Department of Defense, but some have sprung from international or national efforts in ISO or the IEEE. Among these, the IEEE Recommended Practice for Architectural Description of Software-Intensive Systems (IEEE Std 1471-2000) established useful definitions of view, viewpoint, stakeholder and concern and guidelines for documenting a system architecture through the use of multiple views by applying viewpoints to address stakeholder concerns. The advantage of multiple views is that hidden requirements and stakeholder disagreements can be discovered more readily. However, studies show that in practice, the added complexity of reconciling multiple views can undermine this advantage. IEEE 1471 (now ISO/IEC/IEEE 42010:2011, Systems and software engineering — Architecture description) prescribes the contents of architecture descriptions and describes their creation and use under a number of scenarios, including precedented and unprecedented design, evolutionary design, and capture of design of existing systems. In all of these scenarios the overall process is the same: identify stakeholders, elicit concerns, identify a set of viewpoints to be used, and then apply these viewpoint specifications to develop the set of views relevant to the system of interest. Rather than define a particular set of viewpoints, the standard provides uniform mechanisms and requirements for architects and organizations to define their own viewpoints. In 1996 the ISO Reference Model for Open Distributed Processing (RM-ODP) was published to provide a useful framework for describing the architecture and design of large-scale distributed systems. == View model topics == === View === A view of a system is a representation of the system from the perspective of a viewpoint. This viewpoint on a system involves a perspective focusing on specific concerns regarding the system, which suppresses details to provide a simplified model having only those elements related to the concerns of the viewpoint. For example, a security viewpoint focuses on security concerns and a security viewpoint model contains those elements that are related to security from a more general model of a system. A view allows a user to examine a portion of a particular interest area. For example, an Information View may present all functions, organizations, technology, etc. that use a particular piece of information, while the Organizational View may present all functions, technology, and information of concern to a particular organization. In the Zachman Framework views comprise a group of work products whose development requires a particular analytical and technical expertise because they focus on either the “what,” “how,” “who,” “where,” “when,” or “why” of the enterprise. For example, Functional View work products answer the question “how is the mission carried out?” They are most easily developed by experts in functional decomposition using process and activity modeling. They show the enterprise from the point of view of functions. They also may show organizational and information components, but only as they relate to functions. === Viewpoints === In systems engineering, a viewpoint is a partitioning or restriction of concerns in a system. Adoption of a viewpoint is usable so that issues in those aspects can be addressed separately. A good selection of viewpoints also partitions the design of the system into specific areas of expertise. Viewpoints provide the conventions, rules, and languages for constructing, presenting and analysing views. In ISO/IEC 42010:2007 (IEEE-Std-1471-2000) a viewpoint is a specification for an individual view. A view is a representation of a whole system from the perspective of a viewpoint. A view may consist of one or more architectural models. Each such architectural model is developed using the methods established by its associated architectural system, as well as for the system as a whole. === Modeling perspectives === Modeling perspectives is a set of different ways to represent pre-selected aspects of a system. Each perspective has a different focus, conceptualization, dedication and visualization of what the model is representing. In information systems, the traditional way to divide modeling perspectives is to distinguish the structural, functional and behavioral/processual perspectives. This together with rule, object, communication and actor and role perspectives is one way of classifying modeling approaches === Viewpoint model === In any given viewpoint, it is possible to make a model of the system that contains only the objects that are visible from that viewpoint, but also captures all of the objects, relationships and constraints that are present in the system and relevant to that viewpoint. Such a model is said to be a viewpoint model, or a view of the

Electronic lab notebook

An electronic lab notebook or electronic laboratory notebook (ELN) is a computer program designed to replace paper laboratory notebooks. Lab notebooks in general are used by scientists, engineers, and technicians to document research, experiments, and procedures performed in a laboratory. A lab notebook is often maintained to be a legal document and may be used in a court of law as evidence. Similar to an inventor's notebook, the lab notebook is also often referred to in patent prosecution and intellectual property litigation. Electronic lab notebooks offer many benefits to the user as well as organizations; they are easier to search upon, simplify data copying and backups, and support collaboration amongst many users. ELNs can have fine-grained access controls, and can be more secure than their paper counterparts. They also allow the direct incorporation of data from instruments, replacing the practice of printing out data to be stapled into a paper notebook. == Types == ELNs can be divided into two categories: "Specific ELNs" contain features designed to work with specific applications, scientific instrumentation or data types. "Cross-disciplinary ELNs" or "Generic ELNs" are designed to support access to all data and information that needs to be recorded in a lab notebook. Lab Platforms that combine an ELN, LIMS, and scientific data management together, all-in-one configurable software environment. Solutions range from specialized programs designed from the ground up for use as an ELN, to modifications or direct use of more general programs. Examples of using more general software as an ELN include using OpenWetWare, a MediaWiki install (running the same software that Wikipedia uses), WordPress, or the use of general note taking software such as OneNote as an ELN. ELN's come in many different forms. They can be standalone programs, use a client-server model, or be entirely web-based. Some use a lab-notebook approach, others resemble a blog. ELNs are embracing artificial intelligence and LLM technology to provide scientific AI chat assistants. A good many variations on the "ELN" acronym have appeared. Differences between systems with different names are often subtle, with considerable functional overlap between them. Examples include "ERN" (Electronic Research Notebook), "ERMS" (Electronic Resource (or Research or Records) Management System (or Software) and SDMS (Scientific Data (or Document) Management System (or Software). Ultimately, these types of systems all strive to do the same thing: Capture, record, centralize and protect scientific data in a way that is highly searchable, historically accurate, and legally stringent, and which also promotes secure collaboration, greater efficiency, reduced mistakes and lowered total research costs. == Objectives == A good electronic laboratory notebook should offer a secure environment to protect the integrity of both data and process, whilst also affording the flexibility to adopt new processes or changes to existing processes without recourse to further software development. The package architecture should be a modular design, so as to offer the benefit of minimizing validation costs of any subsequent changes that you may wish to make in the future as your needs change. A good electronic laboratory notebook should be an "out of the box" solution that, as standard, has fully configurable forms to comply with the requirements of regulated analytical groups through to a sophisticated ELN for inclusion of structures, spectra, chromatograms, pictures, text, etc. where a preconfigured form is less appropriate. All data within the system may be stored in a database (e.g. MySQL, MS-SQL, Oracle) and be fully searchable. The system should enable data to be collected, stored and retrieved through any combination of forms or ELN that best meets the requirements of the user. The application should enable secure forms to be generated that accept laboratory data input via PCs and/or laptops / palmtops, and should be directly linked to electronic devices such as laboratory balances, pH meters, etc. Networked or wireless communications should be accommodated for by the package which will allow data to be interrogated, tabulated, checked, approved, stored and archived to comply with the latest regulatory guidance and legislation. A system should also include a scheduling option for routine procedures such as equipment qualification and study related timelines. It should include configurable qualification requirements to automatically verify that instruments have been cleaned and calibrated within a specified time period, that reagents have been quality-checked and have not expired, and that workers are trained and authorized to use the equipment and perform the procedures. == Regulatory and legal aspects == The laboratory accreditation criteria found in the ISO 17025 standard needs to be considered for the protection and computer backup of electronic records. These criteria can be found specifically in clause 4.13.1.4 of the standard. Electronic lab notebooks used for development or research in regulated industries, such as medical devices or pharmaceuticals, are expected to comply with FDA regulations related to software validation. The purpose of the regulations is to ensure the integrity of the entries in terms of time, authorship, and content. Unlike ELNs for patent protection, FDA is not concerned with patent interference proceedings, but is concerned with avoidance of falsification. Typical provisions related to software validation are included in the medical device regulations at 21 CFR 820 (et seq.) and Title 21 CFR Part 11. Essentially, the requirements are that the software has been designed and implemented to be suitable for its intended purposes. Evidence to show that this is the case is often provided by a Software Requirements Specification (SRS) setting forth the intended uses and the needs that the ELN will meet; one or more testing protocols that, when followed, demonstrate that the ELN meets the requirements of the specification and that the requirements are satisfied under worst-case conditions. Security, audit trails, prevention of unauthorized changes without substantial collusion of otherwise independent personnel (i.e., those having no interest in the content of the ELN such as independent quality unit personnel) and similar tests are fundamental. Finally, one or more reports demonstrating the results of the testing in accordance with the predefined protocols are required prior to release of the ELN software for use. If the reports show that the software failed to satisfy any of the SRS requirements, then corrective and preventive action ("CAPA") must be undertaken and documented. Such CAPA may extend to minor software revisions, or changes in architecture or major revisions. CAPA activities need to be documented as well. Aside from the requirements to follow such steps for regulated industry, such an approach is generally a good practice in terms of development and release of any software to assure its quality and fitness for use. There are standards related to software development and testing that can be applied (see ref.).