The capability of a program or piece of software to produce the results that it is designed to produce.

Association of Clinical Research Professionals.

Informal software testing performed without planning and documentation.

Any undesirable symptom, occurrence or experience affecting a clinical trial subject.

A design pattern that explains how to move from a poor solution to a preferable one.

Acronym for the American Medical Association.

Private nonprofit organization that oversees the development of voluntary US consensus standards for products, services, processes, systems and personnel. Serves as the US representative to ISO.

International association that offers technologies, concepts, tools and training to quality professionals, quality practitioners and consumers.

A condition that occurs that is not in line with expectations.

Analysis of Variance (Statistics)

A type of program designed to perform a specific function for a user.

This is the process of bringing together data from two or more applications or programs.

FDA's approach to the review of applications that may be affected by wrongful acts that raise significant questions regarding data reliability.

This specifies how different software components interact or communicate with each other.

FDA designation given to drugs, biologics and medical devices that have approved marketing applications (NDAs, BLAs or PMAs).

Acceptable Quality Limit

An independent evaluation of a function or system to meet established standards.

The degree to which a component or interaction is accessible when it needs to be used.

A software product that has been formally agreed upon as basis for further development.

A technique or solution that has proven over time and through experience to lead to the correct results.

Operational testing by existing or potential users--employed as a form of external acceptance testing.

An error in coding while creating a program or application.

A certain version or edition of a program. This is most commonly used to refer to pre-release versions and notated by a "build number."

A type of software that extracts and analyzes various performance metrics and benchmarks. Most software of this type has built-in reporting to allow users to better understand the results.

Corrective and Preventative Action.

The process of confirming that a component, system or program complies with certain specified requirements.

Code of Federal Regulations.

Current Good Manufacturing Practices.

The ability of a software product to be modified as necessary.

Requires general controls to ensure safety and effectiveness.

Requires general and special controls to ensure safety and effectiveness. Special controls may include mandatory performance standards, patient registries for implantable devices and postmark surveillance. Requires 510(k) unless exempted; may require clinical trials.

Requires general controls, special controls and Pre-Market Approval (PMA). Includes devices that are life-sustaining, life-supporting or pose potential risk to patients. PMA may require clinical trials.

Global, nonprofit, standards-developing organization that promotes the development and use of voluntary consensus standards and guidelines within the healthcare community.

Study conducted in humans to determine the safety and efficacy of a new drug, biologic or medical device.

The concept of using remote servers hosted on the Internet instead of a local server or personal computer for storage and data processing.

The ability of a software product to work alongside other software and share common resources.

Software products that are ready-made and available for sale to the general public.

How difficult a product, system, or design is to understand.

An agreement between the FDA and a company that outlines steps that a company has to take in order to return to full, independent production. In other words, it is a very strong regulatory action.

Compliance Policy Guide.

Clinical Research Center.

Contract Research Organization.

Acronym for clinical trial.

A type of software that provides a broad look at a company's customers, potential customers and prospects. It can be used with sales, marketing, customer service and technical support.

A representation of possible changes to the state of data objects.

Analyzing modules of data used in business and analyzing the relationships between each piece of data.

The process involved with fixing programming errors (bugs).

A flaw in a program or system that can cause it to fail at its specified function.

A document that describes one general solution to a problem that repeatedly occurs.

Tasks performed while working towards the final goal of creating a piece of software or other program.

The processes and tools that are used to create software, an application or other programs.

Contains a medical device's production history.

A certain program that interacts with a peripheral or piece of software to help it communicate with the computer or server to which it is attached.

The capability of a program to perform its specified functions relative to the amount of resources used.

These standards replace paper, electronic or other human-readable text with machine-coded and readable documents. This information can be exchanged from computer to computer without the need for human involvement.

A type of software that is used to manage enterprise wide content.

The various tools and plans that come together to coordinate applications within an enterprise.

This type of software can manage all the resources of a business. This includes assets, accounts payable and receivable, inventory, orders, labor, etc.

The first executable statement in a program.

The theory of developing products to better suit the person who is the end user.

A human interaction or mistake that produces an incorrect result.

European Union.

The final executable statement in a program.

A method of developing systems that involves trying a number of potential solutions until one seems to "fit."

Issued by the FDA field investigator after an on-site inspection and lists deficiencies in your quality system. The observations contained in every Form 483 are based on the inspector's interpretation of the regulations as they relate to your operational GMP quality system.

A positive attribute of a program or component.

This system helps integrate a number of financial systems. This includes departments such as accounting, asset management and revenue recognition. The purpose of this is for increased transparency into finances.

US agency that ensures that food is safe and wholesome, that cosmetics will not harm humans, and that medicines, medical devices and radiation-emitting consumer products are safe and effective.

Programming which emphasizes evaluation over expression.

A set of standards developed by the International Society for Pharmaceutical Engineering (ISPE) that provides practical industry guidance to achieve compliant computerized systems to fit their intended use in an efficient and effective manner.

A side to side (horizontal) bar chart that graphically illustrates planning of tasks within a project.

Studying the differences between two information systems or applications. A Gap Analysis determines what steps to be taken in order to move from the current state to the desired future state. Put simply it is the study of how to get from where you are to where you want to be.

International ethical and scientific quality standards for the design, conduct, monitoring, recording, auditing, analysis, and reporting of studies. Ensures the data reported are credible, accurate, and that subject's rights and confidentiality are protected.

Describes the standards by which documents are created and maintained. Good Documentation Practice ensures the validity of data and associated outcomes.

Embodies a set of principles that provides a framework within which laboratory studies are planned, performed, monitored, recorded, reported and archived.

Testing of medical devices, pharmaceutical and diagnostics.

Documentation that explains features of a program and offers basic technical support.

Health Insurance Portability and Accountability Act of 1996.

Human Machine Interface.

Also called a patch, this is a release of code that fixes a bug in the programming.

A broad description of software's capabilities to manage human resources, payroll, productivity and other aspects of a firm's human side.

A company that makes and sells software products that run on one or possibly more operating systems.

Ideas about how a selection of information should be organized, analyzed and treated.

Planning how specific information should be given to and explained to a certain audience.

Physical hardware and networking delivered as a service; normally metered so that a user is only paying for the service they use, rather than operating a full-scale server.

A variable that is read by a certain component.

A test to verify equipment or software systems are compliant with appropriate codes and approved design intentions, and the manufacturer's recommendations are suitable.

The process of combining two or more components into a larger project.

An organization established in 1926 that provides specifications for products, services and good practice, helping to make industry more efficient and effective.

Institutional Review Board; Independent Review Board.

A type of planning and developing process that develops a program in small sections.

A (relatively) simple programming language created by Sun Microsystem. It is class based, object oriented and specifically designed to have as few dependencies as possible. It is used on web pages, computer desktops and mobile phones.

This programming language is similar to Java but was developed independently by Netscape to provide dynamic content to web pages, PDF documents and computer desktops.

A development process that involves both the designer and the client.

A measure against a benchmark used by a firm to determine the success of failure of its activities. This can show growth, shrinkage, trends and variances from period to period.

Is a software solution to manage sample scientific test data and processes, from sample login to the reporting of results.

A concept that emphasizes efficiency and minimizes waste during the development and programming process.

An application based on principles, codes and languages that predate what is considered current technology.

Modification of software after release to repair defects or improve overall performance.

This is a subset of a CRM (Customer Resource Management) program. It helps automate various subsets of a marketing program including email marketing, lead management and campaign management.

Software that manages the demand, ordering, flow and control of materials in a manufacturing organization. This software may be plant-specific or work with several locations at one time.

A medical device is an instrument, apparatus, implant, in vitro reagent, or similar or related article that is used to diagnose, prevent, or treat disease or other conditions, and does not achieve its purposes through chemical action within or on the body (which would make it a drug).

Acronym for New Drug Application.

A programming style that is organized around objects and data rather than actions and logic.

One of the characteristics of cloud computing. It refers to the availability of hardware and software services as needed by a firm. This refers to both IaaS (Infrastructure as a Service) and SaaS (Software as a Service).

A program that has made its source code available for use or modification by other developers.

A test confirming system components function correctly throughout specified operating ranges.

The steps that take place by an organization after a customer places an order. It can include tasks such as fulfilling the order, customer communications and shipping. Order Management also refers to software that streamlines the order fulfillment process.

A variable written by a component.

An arrangement of hiring another company to provide certain services rather than taking care of them in-house.

A type of software that can improve the relationship a company has with its partners and those within the supply chain. It often includes functions such as loyalty and marketing management, commission structuring and access to real-time shipping and delivery information.

Quick repair for a programming problem. A patch is often made available for free download.

This is a council formed by credit card vendors that specifies security standards of credit card information.

The process of checking the work of another industry equal (a peer).

A test that confirms end-to-end functionality as defined by system users.

Initial phase of clinical trials comprising safety studies in humans. Maybe be as few as 10 subjects, often healthy volunteers.

Clinical trials of about 100-300 subjects with the condition of interest. Includes PK, does ranging, safety and efficacy, and is well-controlled.

Larger, well-controlled clinical trials of hundreds to thousands of subjects. Includes both safety and efficacy data. Generally need two well-controlled studies to establish efficacy.

Postmarking clinical trials performed to support labeling and advertising or fulfill safety requirements imposed by FDA at the time of NDA approval.

Platforms refer to the infrastructure components needed to run applications over the internet such as development tools, databases and operating systems. When these are offered on an "as-needed" basis for a fee, it is referred to as PaaS.

The location where a sale takes place. This can be either a physical store location or a website. POS software is the type of software that operates this system.

The characteristic of a program that means it can be used on platforms other than the one for which it was originally developed.

A device legally marketed, to which future 510(k) submission products must be proven substantially equivalent.

A type of software that is targeted towards consulting businesses. This often includes functions such as timesheets, invoicing, general reporting and project management.

Tying together the main attributes of project management into the ERP (Enterprise Resource Planning System). This includes proposal and resource management, billing and time-tracking.

The method for determining the best way to complete a project within a certain period of time.

This type of software organizes the summary information of all current projects. This approach makes it easier for decision makers to see the big picture.

A SDM (Systems Development Method) that involves building an early model (prototype) and refining, fixing and rebuilding it as required to obtain the desired results.

A detailed description of what a program code needs to do--expressed in natural speak rather than programming language.

The degree which a program, component or process meets the required specifications.

Those planned and systematic actions established to ensure that tests are performed and data generated are documented and reported in compliance with applicable regulatory requirements.

The operational techniques and activities undertaken within the QA system to verify that quality requirements have been fulfilled.

Requirements related to the methods used in – and facilities and controls used for – designing, manufacturing, packaging, labeling, storing, installing, and servicing medical devices intended for human use.

Acronym for Regulatory Affairs.

The concept that applications can be developed more quickly when developers use tools like prototyping, user reviews and other less-formal methods of design.

Acronym for Regulatory Affairs Professional Society.

Assigned by FDA and applicable to company-initiated recalls based upon reasonable probability and relative degree of health hazard: Class I – violative product would cause serious adverse health consequences; Class II – violative product may cause temporary or medically reversible adverse health consequences or such consequences are remote; Class III – violative product is not likely to cause adverse health consequences.

A process that improves the inner-workings of a software program without changing the external package.

Testing changes made to a program to see if it will still work.

A document that provides information about the software, application or other product and the tests it underwent prior to release.

A type of architecture that captures the state of data or another resource. It then communicates this state to a requesting application. This architecture is often based on XML.

The needs of a user or device to solve a particular problem.

A tracking number that a company provided to customers when a product is returned for replacement or repair. It is important to connect this system with the manufacturing system to help analyze return rates on defective merchandise.

The amount of profit or cost saving realized by an investment.

A factor that could cause negative consequences in the future; the combination of the probability of occurrence of harm and the severity of that harm.

A systematic process of organizing information to support a risk decision to be made within a risk management process. It consists of the identification of potential hazards and the analysis and evaluation of risks associated with exposure to those hazards.

The planning and organizational process that minimizes the effects of risk on the business or organization as a whole. The systematic application of quality management policies, procedures, and practices to the tasks of assessing, controlling, communicating and reviewing risk.

An underlying factor that caused a problem in a piece of software, application or program.

Any time when a program is operational.

The portion of the CRM that deals directly with the sales team. It automates lead management, tracking, forecasting and other elements of opportunity management.

The ability of software or a program to be expanded as needed to serve future needs.

The practice of utilizing various techniques, both on and off page, to help a website rank higher on the search engines and in turn improve the organic search engine traffic.

Attributes of a product or program to prevent unauthorized access.

A downloadable or orderable update to a customer's software or application.

An agreement between two parties that defines the services to be provided as well as the roles, responsibilities, warranties and other expectations. SLAs also include the metrics by which the provided services will be measured.

Integrates Customer Resource Management, Enterprise Resource Planning and Professional Services Automation to create an end-to-end automation solution.

An XML-based protocol that can swap information between applications through the internet. It is not specific to any one particular platform, language or application.

A device used in testing instead of the specified program, software or device.

Incomplete software testing that ascertains that the most important functions are working properly.

A type of eCommerce study that focuses on influencing the buying decisions of customers using social media or user-generated reviews.

Applications or software programs delivered on an as-requested basis through the internet using a web browser. This uses subscription-based pricing and is accessible on a number of platforms.

A collection of development tools, code and information that makes it possible for developers to write code for a certain platform or software type.

The framework defining tasks performed at each step in the software development process. It consists of a detailed plan describing how to develop, maintain and replace specific software. The SDLC defines a methodology for improving the quality of software and the overall development process.

The system is installed and made operational in the production environment after the system and users' acceptance testing. Activities in the SILC include efforts required for implementation including notification to end users, execution of training, data entry or conversion, and system monitoring.

Testing software to its intended use, i.e. demonstrating that user requirements have successfully passed specific tests.

To ensure that essential job tasks are performed correctly, consistently, and in conformance with internally approved procedures.

A collection of software products or applications that work together to help with the operations of a business or organization.

The process of managing a group of connected processes. This normally refers to helping the manufacturing, warehousing and logistics functions of a business work together towards a common goal.

The framework used to plan the developing process of an information system.

An approach to analysis that focuses on how all the parts relate and work together within a concept of the larger system.

A program divided into three distinctive parts: workstation, business logic and database. Each part operates on a separate section of the network.

Calculations that help customers and potential customers see the big picture in terms of benefits and costs of a particular program or solution.

Everything that a user interacts with that is part of an information system. This includes the keyboard, mouse, touchscreen, etc.

A small program that adds to the features offered by an operating system.

When customers are blocked from upgrading an old version of a program or application to the new version.

A selection of tools and applications that is part of the supply chain management system. It helps the warehouse run in conjunction with the supply chain as a whole.

Most serious FDA post-audit letter, demanding action within 15 days.

Software based on the internet that general runs within a web browser. These often run on a common protocol such as HTTP, XML or WSDL.

Programming code that is difficult or impossible to read.