"MONITORINGZ" - software for trending microbial cleanliness and number of airborne particles in clean production areas (1)

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Software applicationMONITORINGZ
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What is MONITORINGZ ?

• MONITORINGZ is a multiuser server-client
  application designed for input, storage and
  processing of sampling results for microbial
  cleanliness and number of particles in clean
  production areas, usually called environmental
  monitoring.
• Application consists of two parts database
  back-end in PostgreSQL server and client
  front-end interface in MS Access.

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What is MONITORINGZ ?
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Why is it important to regularly perform
environmental monitoring and report about
collected results?

• Environmental monitoring of clean production
  areas belongs to critical GMP requirements in
  pharmaceutical, food and similar industries.
• Sampling on microbial cleanliness and number of
  airborne particles are obligations prescribed by
  legal regulative, and as such they are subject of
  state inspections and inspections of business
  partners.
• By timely sampling and reporting, it is possible
  to determine contamination in early stages,
  before end-product quality is questioned. In such
  way, all possible sources of contamination are
  timely detected, so that end-product quality is
  ensured and risk of recall from market is
  significantly lowered.
• Regulative, inspections, as well as internal
  documentation of companies often require
  graphical and statistical trending of microbial
  cleanliness and number of particles in clean
  areas.
• By carefully designed and processed reports you
  show care for end-product quality and build
  positive image of your company.

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Why do you need MONITORINGZ?

• Trending and processing of environmental
  monitoring results is often time-consuming and
  hard job, for many reasons
• Complicated sampling matrix (many departments,
  different production plants, areas, sampling
  types and sampling locations, different
  cleanliness classes and sampling frequencies)?
• Sampling system based on batch numbers, where
  results for quite different samples are put in
  the same batch number
• Great amount of sampling data that must be
  processed in short time (usually just before an
  inspection)?
• Lack of time and personnel
• Non-systematical approach
• Complicated organization scheme where
  responsibilities regarding data processing are
  not clearly defined
• Form of reports is not defined (every employee or
  department has own approach)?

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Why do you need MONITORINGZ?

• Although sampling of different sampling locations
  under the same batch number represent logical and
  practical system of sampling, archiving of
  sampling data under such batch reports makes
  classical paper reports useless for statistical
  and graphical trending of results. In order to be
  trended, sampling results must be sorted by key
  of sampling locations. Therefore it becomes
  necessary to manually copy results from paper
  batch reports to Excel sheets. Consequences of
  such inefficient classical system of data
  processing are following
• Much archived, but useless sampling data
• Unnecessary multiplying of job (copying from
  paper batch reports to Excel sheets)?
• Loss of time and human resources
• Unreadiness for GMP inspections
• MONITORINGZ is designed with purpose to make
  the job of input, storage and processing of
  environmental monitoring results easy, efficient
  and reliable. Emphasize is put on easy input and
  powerful reporting of sampling results.

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Why do you need MONITORINGZ?

• Program MONITORINGZ provides
• Easy and logical input of organization structure
  and sampling matrix
• Fast and easy input of sampling results through
  forms that resembles classical paper forms
• Powerful reporting and data navigation, including
  statistical and graphical trending of results by
  sampling locations
• Possibility of exporting reports to different
  external formats (.txt, .xls, .rtf, .pdf, .html,
  .snp etc.)?
• Easy data collecting from external sources
  (Excel sheets, continuous particles counter
  etc.)?
• Data access control through user groups and
  passwords of different authorization levels
  (according to 21CFR Part11)?
• Control of data authenticity through
  automatically generated audit-trail record
  (according to 21CFR Part11)?
• Automatically updated sampling time schedule

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Basic features of MONITORINGZ
Regular environmental monitoring of clean areas
is essential part of good manufacturing practice
in pharmaceutical and similar industries.
Although regulative, inspections and internal
documents of companies demand periodical
graphical and statistical trending of results, in
real life it is a requirement hard to accomplish.
MONITORINGZ offers wide spectra of predefined
reports, including tabular, graphical and
statistical trends. In the same time, MONITORINGZ
keeps simple and fast data input through forms
that are user-friendly, designed in imitation of
usual paper forms. Reports can be printed on the
paper (hardcopy) or stored in some electronical
format, such as .pdf or .snp format, which makes
it possible to store and review reports without
need for paper print-out. Such reports can be
permanently stored in any electronic media, as
well as imported into electronical data
management systems (Documentum, for example). As
MONITORINGZ client interface is integrated into
MS Office system, reports can be easily exported
to different formats, such as XML, Text, HTML,
Excel (.xls), Word (.rtf) etc.
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Basic features of MONITORINGZ
Besides predefined reports, it is possible to
search and filter results by using datasheet
tables (similar to Excel sheets), pivot tables
and pivot charts. These advanced options provide
tools for fast search and filtering of database
with optional searching criterias, so making it
possible to create specific ad-hoc reports.
Fast navigation through data is possible through
cascading view survey form, that consists of
hierarchy of subforms with tabs and combo boxes.
By navigation through cascading view, one can
instantly get information from all kind of
reports in one window. To have better control
over sampling dynamics users can view and print
sampling time-schedule in any moment. According
to GMP and 21CFRPart11 data access is defined by
8 levels of authorization. Every users group has
predefined authorizations and restrictions.
Groups are defined according to usual roles in
organization units. According to GMP and 21 CFR
Part11 requirements, every action on data
(insert, update, delete) is permanently recorded
in automatically generated record (audit
trail). From audit trail, it is always possible
to investigate who and when entered, changed or
deleted which data.
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Authorization levelsand user groups
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Login to the server

• After starting the application, a login form
  appears. A user connects to the database by
  providing correct username and password.

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Main switchboard

• After successful login to the server, user can
  choose between basic functionalities of the
  application. By pushing a button in the main
  switchboard or by choosing from the menu it is
  possible to open following basic windows
• Input of sampling results - opens a form for
  regular input of sampling results into the
  database
• Correction of entered results - opens a form for
  correction of errors in previously entered
  results
• Viewing of results and reports creation - opens
  a form in which user can choose between different
  types of reports and views of results
• Organization structure and sampling matrix -
  opens a form for input of organization structure
  and sampling matrix
• Options different options regarding data input
  and localization
• Audit trail opens a form for viewing
  audit-trail record
• Password change opens a form for password
  change
• Users and user groups opens a form for adding
  and removing users from user groups

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Main switchboard
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Options

• Before we can start with regular usage of the
  program, some options important for normal
  functioning of the application must be defined.
  The Options window consists of three tabs
• Input of microbial sampling results
• An authorized person chooses whether batch
  microbial sampling results will be entered into
  the database on the basis of sampling types or on
  the basis of production areas (rooms).
• Localization of time units
• In this tab, an authorized person translates time
  units from English to corresponding expressions
  in the local language.
• Localization of batch status expressions
• An authorized person translates English
  expressions for status of batch results to
  corresponding expressions in the local language.

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Options
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Organization structure and sampling matrix

• Before we can start with regular input of
  sampling results and reports creation,
  organization structure and sampling matrix must
  be defined. Therefore we must first input data
  about sampling matrix, including all relevant
  data about sampling locations, sampling
  frequency, alert and action limits.
• Through appropriate form for input of
  organization structure and sampling matrix, an
  authorized person enters data about company,
  departments, production plants, production areas
  (rooms), microbial sampling types and cleanliness
  classes.
• Finally, an authorized person enters sampling
  matrix for microbial sampling and sampling of
  particles.

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Data input about company, departments and
production plants
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Data input about microbial sampling types,
cleanliness classes and production areas (rooms)
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Data input of microbial sampling matrix and
number of particles sampling matrix
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Input of sampling results

• Regular input of sampling results is simple and
  user-friendly. Through appropriate combo boxes,
  user chooses department, production plant and
  sampling type or production area (room) where
  sampling is taking place. A form for data input
  then appears. The form is based on the values in
  combo boxes and data in sampling matrix. It
  consists of two tabs
• Input of microbial sampling results
• (depending on the chosen option, batch data
  input can be organized on the basis of sampling
  types or on the basis of production rooms)?
• Input of sampling results of number of particles
  in the air

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Input of microbial sampling results by sampling
types
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Input of microbial sampling results by production
areas
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Input of sampling resultsof number of airborne
particles (by production areas)?
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Correction of errors in previously entered
sampling results

• Operators that regularly input sampling results
  can unintentionally make a mistake. Once they
  confirmed data input, members of these user
  groups can do nothing to correct the error.
  According to GMP and 21 CFR Part11, it is
  required that a user of the higher authorization
  level corrects the error. Members of the higher
  level authorizations user groups should be
  persons that are ordinated to operators that
  perform regular data input.
• According to 21 CFR Part11, audit trail keeps
  originally entered data, as well as any later
  update or deletion. Also, audit trail records
  time stamp and user name of the user that
  entered, changed or deleted data. From
  audit-trail, it is always possible to examine who
  and when entered, changed or deleted which data.
• An authorized user can correct and delete entered
  batch sampling data, through the window for
  correction of results.

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Correction of errors in previously entered
sampling results
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Viewing of results and reports creation

• Data entered to the database become useful only
  when processed in form of thoughtful report.
  Therefore MONITORINGZ provides fast and efficient
  data processing of sampling results through
  predefined reports and views, including tabular,
  graphical and statistical processing of sampling
  results.
• Reports are created through a form in which user
  chooses departments and plants to be included in
  reports, start and end date, report type, as well
  as option of showing all results or only
  deviations.
• Reports can be printed out on paper or can be
  saved in some protected electronic format (.snp
  or .pdf format). This enables electronic storage
  and later viewing of reports without necessity
  for printing on paper. Saved reports can be
  stored in any electronic media, as well as
  imported into system for electronic management of
  documentation, such as Documentum. On account of
  being integrated into MS Office system, reports
  can be exported to different formats, such as
  Text, HTML, Excel, Word etc.

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Viewing of results and reports creation

• Besides predefined reports, it is additionally
  enabled to search and filter data by using
  datasheet tables (similar to Excel tables) and
  so-called pivot tables and pivot charts. These
  advanced options provide tools for fast and
  flexible search and filtering of database with
  defined searching criteria. In that way you can
  get very specific ad-hoc report.
• Fast searching of data is also enables through
  the cascading survey form for data view of
  results. It is based on the hierarchical system
  of forms and subforms with tabs and combo boxes,
  by which you can navigate through sampling
  results. This view gives you concentrated
  information from all kinds of reports in only one
  window. In distinction from predefined reports
  that are adjusted for printing and archiving of
  results, cascading view is adjusted for fast
  viewing of results.
• Additionally, it is enabled to view and print
  sampling time-schedule in any moment, which
  improves control over sampling.

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The window for viewing of results and reports
creation
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Reports

• The window for viewing of results and reports
  creation enables fast creation of the following
  reports
• List of batches simple list of batch numbers
  sorted by sampling dates, with noted batch
  statuses
• Report by batches results are sorted by batch
  numbers, in the same way as they are entered into
  the database
• Tabular-graphical-statistical report by sampling
  locations - exhaustive report with detailed
  tabular, graphical and statistical trending, in
  which results are sorted by samples (sampling
  locations). This type of reports contains
  statistical evaluation on every hierarchical
  level (departments, plants, sampling types,
  areas, samples).
• Tabular report by sampling locations
• Statistical report by sampling locations
  condensed statistical report by all hierarchical
  levels (department, plant, sampling type, area,
  sample)?
• Graphical-statistical report by sampling
  locations
• Graphical report by sampling locations
• Time-schedule (short)?
• Time-schedule (detailed)?

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List of batch numbers
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Report by batch numbers
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Tabular-graphical-statistical reportby sampling
locations
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Tabular-graphical-statistical reportby sampling
locations
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Tabular-graphical-statistical reportby sampling
locations
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Tabular-graphical-statistical reportby sampling
locations
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Tabular-graphical-statistical reportby sampling
locations
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Tabular-graphical-statistical reportby sampling
locations
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Tabular-graphical-statistical reportby sampling
locations
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Short statistical reportby sampling locations
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Short statistical reportby sampling locations
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Time schedule of sampling
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Time schedule of sampling
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Exporting of reports to external formats(.txt,
.rtf, .xls etc.)?
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Viewing of results through sampling data survey
form

• If a user just wants to take a brief view and
  simply navigate through results without need for
  printing on paper, opening of the data survey
  form is much suitable than viewing of reports.
• In opposite to reports which are adjusted for
  printing on paper, this survey form consisted of
  hierarchical system of subforms and tabs is
  suitable for viewing results on screen. It
  contains most important information from all
  kinds of reports, that are placed in just one
  interactive screen.
• The window for viewing of results consists of
  system of forms and subforms with tabs and combo
  boxes lists, by which user can navigate through
  results. Detail data are presented in tables,
  graphs and statistics.

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Survey form for viewing of results
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Survey form for viewing of results
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Survey form for viewing of results
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Survey form for viewing of results
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Survey form for viewing of results
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Survey form for viewing of results
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Datasheet reports

• It is possible to view sampling results in
  spreadsheet tabular form, similar to Excel
  sheets. It is called datasheet view. Those
  familiar with Excel would easily get accustomed
  with datasheets.
• In datasheet view, columns can be shrinked or
  spread, shown or hidden, data can be sorted
  ascending or descending The main advantage of
  datasheets is possibility of searching and
  filtering.
• In contrast to predefined reports, datasheet view
  gives freedom in viewing, filtering and sorting
  of data, so it is suitable for creation of
  specific ad-hoc reports and advanced data
  processing.

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Datasheet reports
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Filtering and searching data

• Filtering and searching of data is almost the
  same like in MS Excel, so everybody familiar with
  Excel will be familiar with these advanced
  options.
• Filter by Selection Data is filtered by
  criteria of the value in selected cell. All data
  that satisfy the criteria will be shown.
• Filter Excluding Selection All data except
  those that satisfy filtering criteria will be
  shown.
• Filter by Form This option enables filtering by
  multiple criteria in one step. Filtering criteria
  can be defined separately for every column in
  table.
• Advanced Filter/Sort This is the most advanced
  way of filtering data, suitable for advanced
  users, especially those that are familiar with
  making queries on databases. By choosing this
  option, you can use Query Builder with
  possibility of creating queries with different
  filtering criteria. This advanced tool offers
  vast freedom in searching and filtering sampling
  results.
• Besides filtering, you can use Searching tool by
  choosing Records/Find, which resembles similar
  tools in MS Word and Excel.

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Filter by Selection
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Filter by Form
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Advanced Filter/Sort
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Searching data (Records/Find)?
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Pivot tables and pivot charts

• Pivot tables and pivot charts are very powerful
  and flexible tools, which provide advanced
  filtering, summarization and cross-tabulation of
  hierarchical data.
• In pivot tables you can define the data values
  for rows, columns, pages and summarization. The
  pivot table frame consists of horizontal and
  vertical boxes Filter Fields, Column Fields, Row
  Fields, and Totals or Detail Fields, for which
  you provide data values by simply drag and drop
  appropriate fields from list. You can rotate the
  columns and rows to summarize the data from
  different points of view.
• Analogously, you can define fields for different
  sections of pivot charts Series Fields, Category
  Fields, Data Fields and Filter Fields.
• In contrast to predefined reports, during
  creation of pivot tables and charts, users have
  absolute freedom. Pivot tables and graphs are
  empty frames that are populated with data by
  simply drag and drop of fields into different
  sections of the frame.

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Pivot Tables
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Pivot Tables
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Pivot Tables
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Pivot Charts
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Pivot Charts
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Pivot Charts
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Pivot Charts
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Audit-trail record

• Regulative demands that software applications
  handling GMP-critical data automatically generate
  record about all inserts, updates and deletions
  of data.
• Program MONITORINGZ automatically creates
  audit-trail record in the form of original tables
  copies, in which all originally entered data are
  kept permanently recorded, as well as all later
  updates and deletions.
• In audit trail, It is also marked which user
  entered, changed or deleted which data, as well
  as action type (insert, update, delete) and
  timestamp of action.
• From audit trail, It is always possible to
  investigate who and when changed or deleted data,
  as well as what was the original data. In order
  to prevent misuse, the content of audit-trail
  record can't be changed or deleted.

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Audit-trail record
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CONTACT

• Zlatko Matic,
• Požeška 236, 35404 Cernik
• Croatia (Hrvatska)
• e-mail matalab_at_gmail.com
• http//matalab.freehostia.com