Features List
 
Associations
  

Associations are unique to ESM and are designed to specifically address several specific GMP needs. One of the greatest problems faced in the GMP industry is the need to evaluate the impact a change may have on ancillary or support systems or documentation for the item being changed. Often, the person(s) reviewing a requested change have no way of knowing what the effect of the change will be on other documents or specifications. ESM solves this problem by providing a convenient mechanism to relate or "associate" an object in the database with another object in the database.

  

ESM allows you to associate any kind of ESM object to another object. You can associate a document to a component, a component to a component, a folder to a document, etc.

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Document- or File-based Data
  

While much of the information that defines a specification can be stored in a traditional database table, other types of information comprise GMP specifications, also.

 

Documents are a good example of a non-tabular form of a GMP specification. A simple process or system description written in Microsoft Word, for instance, may be considered part of a system specification. Similarly, an AutoCAD drawing or a list of SOPs or User Manuals could be considered part of a GMP specification.

ESM makes it easy to add documents, drawings and files of any type to a GMP specification. Often, these files are stored on a network server but due to obscure naming practices may be difficult for anyone other than the owner to locate. ESM lets you link these documents to the database to make it easy to collect these file references into one logical, structured tree that everyone in the company can access.

Note that files do not have to be moved in order to be linked to the database; they can reside anywhere within the network so changes to your existing naming conventions and storage conventions do not need to be made.

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Import Existing Knowledge
  

What to do with legacy data? ESM makes it easy to import existing knowledge into the database. Using ESM’s Get External Data utility, you can bring data from existing Excel spreadsheet/databases into ESM.

Simply specify the spreadsheet containing the data you wish to import and map the fields to the fields in the ESM database. Your data is automatically entered into the system. Now everyone in the company can access the data.

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Organization of Specification Information
  

One of the greatest problems faced by pharmaceutical firms today is locating accurate specification data.

  
  

The above questions are often heard from within various parts of most pharmaceutical organizations. Unfortunately, the answers often vary depending on the type of specification data being sought, or worse yet, may depend on the person(s) looking for or answering the question.

ESM solves the problem by providing one shared source of data that everyone can use to find specification information. ESM’s tree structure is a familiar and logical way to present structured information.

The ESM tree structure organizes information and data into logical, groups or categories. All of the information for a system, process or facility can be grouped into a branch of the tree. Each branch of the tree may be used to represent a different kind of information or type of information. The flexibility of the tree structure allows for an infinite amount of customization to meet your particular needs

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Query
  

ESM has a powerful search engine that allows you to build sophisticated database queries to find the information you are looking for. Queries can be established to find a single item or a collection of items within the database.

The easy to use ESM query wizard walks you through the process of building your query. If needed, full Boolean logic support is available for your query. When your query has been built and run, you can send the results of the query to Microsoft Excel for further processing. Your query can, of course, be saved for later re-use.

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Security
  

ESM models the industry standard Microsoft NT security schema, whereby each user has a unique ID and password. ESM also supports the "group" structure. Each user can be a member of one or many groups. Each group can be assigned an access level for any collection of groups within the ESM database.

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Specification Generation

When asked, "What do you dislike most about your job?", a group of engineers unanimously responded, "Writing specifications!"

ESM takes the trouble, time and inconsistency out of writing specifications by writing them for you. Using standard Microsoft Word document templates, ESM collects all of the specification data entered into the ESM database for a system, area or even facility and creates a detailed, standardized specification document.

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Standardization  (preferred parts, standard system templates)
  

ESM helps standardize the way specifications are defined by utilizing standard table definitions and structured specification trees.

Standardized tree structures for common systems are supplied with ESM. Using ESM’s Database Administration Program (DAP) the standard system configurations can be modified to reflect your organization’s standardized business practices. Additionally, new system structures can be added. Each time a system is added to the ESM database, the structure is built from the standardized configuration defined by you.

 

ESM table definitions are defined by you to contain the information your organization considers to be important. Each time data is entered into an ESM table, the data format and content has been pre-defined, thus preventing individual interpretation of "what’s important".

Further strengthening ESM’s standardization features is the Preferred List. The preferred list is a configurable list of preferred parts/components/objects that is pre-populated with data. The preferred list makes it easy to enter data consistently.

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Tabular Data
  

Much of the data that represents equipment, system or process specifications can best be defined in a traditional table structure.

ESM provides an almost infinitely flexible table structure allowing you to define tables which can handle any form of table-based data. Tables can contain text, date, numeric, binary and even OLE data. Tables can even be changed "on-the-fly" after they have been created so you are never locked in to a table definition during initial system configuration.

ESM’s preferred parts feature helps you standardize on a pre-defined list of parts or components that you want to use whenever possible. Preferred parts improves standardization and reduces data entry time for repetitive specification information.

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Track Changes
  

How many times have you been reviewing a specification (either your own or someone else’s) and asked yourself, "When was this change made? And why?"

 

  

ESM incorporates a multi-level Revision History feature that gives you the flexibility to track and control changes to ESM files and database entries. You can set the Revision History level for any object in the ESM database to a level appropriate for that object. In some cases, no Revision History is needed at all. As a specification progresses through its lifecycle, you may want to have a reminder that asks you if you want to enter a Revision History reason for a change. Near the end of the lifecycle, you may want to force the user (or yourself) to enter a reason for every change made to the specification. ESM provides you with the ability to set the Revision History level for every object in the database.

The Revision History for an ESM object can be viewed in detail by simply clicking on the Revision History tab within ESM. Full audit trail capability is available to enforce CFR Part 11 compliance.

The Revision History feature is an important aspect of any GMP software and is found in all of cGMP Systems software products.

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VPM Integration

One of the most difficult problems facing validation personnel worldwide is the issue of the ever-changing specification. Although validation documents are supposed to be based on specifications, frequently this does not occur. Sometimes specifications do not exist, or they are difficult to locate or, more often, they are available but not up-to-date. Regardless, the protocols must be generated.

Frequently, protocols are generated from old or erroneous specification data. The result? Erroneous protocols that either fail their acceptance criteria or produce deviations or discrepancies that must, in turn, be explained. These problems result in increased cost and time.

cGMP Systems has solved this problem by dynamically linking the protocol documents to the specification data they are based upon. No longer must a validation person track down the most up-to-date specification for a piece of equipment or a process, the protocol automatically is linked to the correct data. The specification data is stored in the ESM database.

Protocols can be updated with the most recent specification data, thus eliminating the errors produced when protocols refer to inaccurate specification data.

This revolutionary feature is available to users of both the ESM and VPM modules.

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