MONITORINGZ is a multiuser server-client application designed for input, storage and processing of sampling results for microbial cleanliness and number of airborne particles in clean production areas, usually called “environmental monitoring”.

1. Software application
“MONITORINGZ”

2. 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.

3. What is “MONITORINGZ” ?

4. 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.

5. 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)

6. 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.

7. 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

8. Basic features of MONITORINGZ
Regular environmental monitoring of clean areas is essential part of good ma-
nufacturing practice in pharmaceutical and similar industries. Although regula-
tive, 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 electro-
nical 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 per-
manently 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.

9. 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 databa-
se with optional searching criterias, so making it possible to create specific
“ad-hoc” reports. Fast navigation through data is possible through casca-
ding view survey form, that consists of hierarchy of subforms with tabs and
combo boxes. By navigation through cascading view, one can instantly get in-
formation 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 restric-
tions. Groups are defined according to usual roles in organization units. Ac-
cording to GMP and 21 CFR Part11 requirements, every action on data (in-
sert, update, delete) is permanently recorded in automatically generated re-
cord (“audit trail”). From audit trail, it is always possible to investigate who
and when entered, changed or deleted which data.

10. Authorization levels
and user groups
ROLE
GROUP1 X X
GROUP2 X X X
GROUP3 X X X X
GROUP4 X X X X
GROUP5 X X X X X X
GROUP6 X X X X X X X
GROUP7 X X X X X X X X X
ADMINS X X X X X X X X X X
Viewing of
sampling
results
Viewing of
organization
structure and
sampling
matrix
Viewing of
audit trail
Viewing of
users and
roles
Sampling data
input
Correction
and deleting
of entered
sampling
results
Insert, update
and delete of
organization
structure and
sampling
matrix
Choosing the
microbiologica
l sampling
logic (by
sampling
types or by
areas)
Time units and
batch statuses
localization
Creation and
deletion of
users

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

12. 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

13. Main switchboard

14. 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.

15. Options

16. 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.

17. Data input about company, departments
and production plants

18. Data input about microbial sampling
types, cleanliness classes and
production areas (rooms)

19. Data input of
microbial sampling matrix and number
of particles sampling matrix

20. 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

21. Input of microbial sampling results by
sampling types

22. Input of microbial sampling results by
production areas

23. Input of sampling results
of number of airborne particles
(by production areas)

24. 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.

25. Correction of errors
in previously entered sampling results

26. 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.

27. 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.

28. The window for viewing of results
and reports creation

29. 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)

30. List of batch numbers

31. Report by batch numbers

32. Tabular-graphical-statistical report
by sampling locations

33. Tabular-graphical-statistical report
by sampling locations

34. Tabular-graphical-statistical report
by sampling locations

35. Tabular-graphical-statistical report
by sampling locations

36. Tabular-graphical-statistical report
by sampling locations

37. Tabular-graphical-statistical report
by sampling locations

38. Tabular-graphical-statistical report
by sampling locations

39. Short statistical report
by sampling locations

40. Short statistical report
by sampling locations

41. Time schedule of sampling

42. Time schedule of sampling

43. Exporting of reports to external formats
(.txt, .rtf, .xls etc.)

44. 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.

45. Survey form for viewing of results

46. Survey form for viewing of results

47. Survey form for viewing of results

48. Survey form for viewing of results

49. Survey form for viewing of results

50. Survey form for viewing of results

51. 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.

52. Datasheet reports

53. 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.

54. Filter by Selection

55. Filter by Form

56. Advanced Filter/Sort

57. Searching data (Records/Find)

58. 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.

59. Pivot Tables

60. Pivot Tables

61. Pivot Tables

62. Pivot Charts

63. Pivot Charts

64. Pivot Charts

65. Pivot Charts

66. 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.

67. Audit-trail record

68. CONTACT
Zlatko Matić,
Požeška 236, 35404 Cernik
Croatia (Hrvatska)
e-mail: matalab@gmail.com
http://matalab.freehostia.com