Management of the registering documentation of the pharmaceutical quality system on the DIRECTUM platform

Praksea Rus LLC is child structure of corporation Praxair, Inc. The company renders services in production, construction and operation of industrial airdividing installations, the systems of gas providing and also service in supply of technical, medical and special gases and the innovative technologies connected with it which allow to increase performance due to reduction of amount of the consumed energy and to increase the level of environmental safety.

In the Russian market of industrial gases and technologies Praksea Rus LLC is since 2008. During the presence in the territory of the Russian Federation the Praxair company purchased such enterprises as Volzhsky Azot LLC, Argon Service LLC and JSC Volgograd Oxygen Plant in property. Total production capacity of five large projects which are already implemented by the company in Russia exceeds 3,500 tons of oxygen, nitrogen and argon in day, plus small volumes of hydrogen. Deliveries of not expensive and highly reliable industrial gases in the Volgograd, Sverdlovsk, Samara, Rostov and Nizhny Novgorod regions allow to provide requirements of different customer groups, including clients of the metallurgical, chemical, food, medical and glass industry.

System Selection

The choice of the DIRECTUM system for the solution of the specified tasks was caused by the whole complex of factors. Existence of ready tools based on which it is possible to create the solution which is completely meeting needs of the customer in short terms became one of main.

In the product range which is made and delivered to clients of Praxair stand gases of medical appointment, in particular, medical oxygen which is delivered as in gaseous state, shaken on cylinders alone, and in the form of liquid. Requirements of orders of the Ministry of Industry and Trade No. 916 "About the approval of Rules of production organization and quality control of medicines" and No. 1997 "About the approval of Recommendations about production organization and quality control of medicines" are fully applied to medical oxygen. Production of each series of medical oxygen should be followed by collecting, the analysis and the approval of the registration file which contains records – the documents fixing accomplishment of different actions for the proof of compliance to instructions and the documents confirming quality of the made series.

The registration file on medical oxygen contains about 15 documents which are processed by different workers at different stages of a technology chain. At the same time the structure of documents and an order of their design can differ for liquid and gaseous medical oxygen. For increase in transparency and controllability of processes of collecting of the registration file and also for ensuring reliable storage and simplification of preparation of documentation for checks upon the demand of regulatory authorities, in Praksea Rus LLC the decision to organize collecting, a statement and storage of the registration file in electronic form using an information system was made. Such opportunity separately makes a reservation in the order of the Ministry of Industry and Trade No. 916 "About the approval of Rules of production organization and quality control of medicines".

Project Tasks

During the project specialists of Akelon company should solve the following key problems:

• automate business process of collecting, the analysis and approval of the file of the registering documentation;
• create uniform electronic archive of the registering documentation according to standard GMP;
• create specifications and document templates of the file for each business process;
• provide support of version control of each separate document;
• automate processes of creation of documents;
• provide access to a system through Internet (web access).

Project solutions

As a task specific therefore the solution "by GMP was developed for the solution of assigned tasks. Quality management". This solution includes a set of reference books, document templates and standard routes for automation of process of collecting and the approval of the file on a product series.

As Praksea Rus LLC is child structure of Praxair corporation, not only Russian-speaking workers therefore the solution was translated into English will use the solution.

Business processes

The Praksea Rus LLC company makes and delivers to the clients medical oxygen in two aggregate states: liquid, poured in conveyor tanks, and in gaseous, packed into cylinders of standard tanks. Depending on aggregate state and a method of packaging, the release of a product series is performed on one of business processes:

• production of a series of liquid oxygen (BULK Series);
• production of a batch of liquid oxygen (Batch of BULK);
• production of a batch of liquid oxygen for the subsequent swing on cylinders (A batch of BULK for PAG);
• production of a batch of the gaseous oxygen packed into cylinders (the Batch of PAG).

During the project for each of listed business of processes was developed a standard route for collecting, the analysis and the approval of the registration file and also specifications and document templates which should be a part of the registration file were developed.

For work with the solution the special cover is created. On a cover links for start of a standard route on collecting and the approval of the file for each type of a series, the link for opening of the key reference book "Series" and functionality on document retrieval of the file were taken out.

Registers, reference books and standard routes

The central komponenty information system there was a reference book "Series" which represents the unified register of all product series made on different platforms. End-to-end automatic numbering allows to identify unambiguously a series, and the card of the reference book contains the main information on each series. Without fail for each series it is specified:

• nomenclature position which is made within release of a series;
• type of a product which is made (liquid or gas);
• the platform on which this series is produced in;
• capacity in which a series will be packaged;
• the authorized person on production control;
• the authorized person on quality control.

Important parameter of a series is its type. Depending on type of a series is defined what nomenclature positions can be made within release of this series and also a standard route along which collecting of the registration file will be performed.

The following reference books were developed for filling of a card of a Series:

• Products. The reference book contains information on products which are turned out by the enterprise.
• Units of measure. The reference book is intended for information storage about units of measure of volumes of finished goods.
• Platforms. The reference book contains information on platforms on which products are made.
• Tanks. The reference book is intended for information storage about the used tanks.
• Nomenclature. The reference book is intended for data storage about the nomenclature positions made on different platforms.

Business process of tests of quality

Protocols of the executed tests of quality and the analytical sheet with summary results of tests should be a part of the registration file on each product series. On the basis of the analytical sheet the person authorized to control product quality does the conclusion about compliance of a series to pharmakopeyny article of the enterprise and to the GMP standards. For different nomenclature positions the quality test set which should be executed can differ.

The reference book "Tests of Quality" is developed for information storage about tests of quality. In the reference book the name of the test, its description is set and also the template of the electronic document which will be used for formation of protocols of tests of this kind is specified. In the reference book "Specifications of Tests of Quality" lists of tests which should be executed for certification of a series of this or that nomenclature position are set. For example, for a nomenclature position "Oxygen liquid medical" tests according to the specification are executed:

The specification is set in a card of a nomenclature position (reference book "Nomenclature"). Thus, it is possible to configure flexibly test sets which should be executed for different types of products.

During business process of collecting of the file, the worker responsible for carrying out tests receives a task for accomplishment of tests of quality in DIRECTUM:

The card of a series on which collecting of the file is performed is enclosed in a task. The Add Tests button is provided in a card of a series.

On clicking this button for this series the filled forms of protocols of tests of quality according to the specification are automatically generated. Responsible should fill result of tests and put down sign of compliance of result of necessary indicators.

If in the course of tests discrepancies to normative indicators were detected, it is necessary to record a deviation. The reference book "Magazine of Deviations" was for this purpose developed. For creation of a deviation the Add a Deviation button is provided in a card of a series.

Sets of documents and use of templates

For creation of all documents entering the file templates are used that allows to customize flexibly a system and to maintain relevance of forms by forces of the regular system administrator, without resorting to the help of developers.

During passing of standard routes collecting, check, assessment and the approval of the file is performed. As a result, a set of documents contacts a card of each series, each of which is checked and approved by electronic signatures of authorized persons. Prohibition on removal of documents from a system provides integrity of the file, and support of version control allows to manage changes flexibly.

Use of the solution through web access

Praksea Rus LLC is child structure of Praxair corporation, has geographically distributed structure and a set of remote divisions. Employees of the company should address far off documents in a system in the course of their consideration and approval.

Special expansion of Praxair.GMP was developed for work in web access. In web access the possibility of creation and entering of documents of the file, task performance along standard routes of collecting and the approval of the file on a product series is implemented.

Results

The project was successfully implemented in four months, works on implementation are performed in full. Workers of production (remote divisions) will actively work with the module.

According to the results of an implementation project of a management system for the registering documentation of the pharmaceutical quality system on the DIRECTUM platform the following tasks were solved:

• process of collecting of the file on a product series of medical oxygen for Praksayr Volgograd LLC and laboratory of quality control of JSC VKZ is automated;
• the unified register and electronic archive of the file on product series is created.

Creation of the file on a product series on the basis of templates allowed to simplify and reduce document creation time. The electronic archive of the file on a product series solved the following problems:

• control of obligatory creation of necessary documents in the file;
• exception of loss of documents;
• simplification of preparation of documents for checks at the request of regulatory authorities.

Development Plans

The universality of a system and its adaptation to new business to processes allow to perform without the assistance of developers tunings for use of a system at release of series not only medical, but also industrial output. In the long term a system will be used for the organization of processes of quality control of all product range in Praksea Rus LLC.

In parallel with use of the developed module behind quality control of production of Praksea Rus LLC is going to use the module Office of the DIRECTUM system.

Project terms

Project start date: 06.07.2015. Project completion date: 30.10.2015.

Contractor and course of the project

The developed and geographically distributed structure of Praksea Rus LLC required creation of a common information space for effective work, rather low cost of support of infrastructure and development of functionality. The existing systems not fully met the arisen business needs therefore the management of Praksea Rus LLC made the decision on reengineering of processes and the choice of an ECM system.

Advantage of Directum- is an existence of the subject-oriented building tool IS-Bulder allowing to adapt quickly a system, to integrate with other applications, to upgrade by own forces taking into account development of the company. The Akelon company, the general partner of DIRECTUM company became the contractor of an implementation project.

The following tasks were set for a project team of the contractor:

• creation of uniform electronic archive of the registering documentation of the pharmaceutical quality system according to the GMP standard;
• business process automation of preparation, approval and the approval of the registering documentation;
• integration of a system into information space of the company.

According to technology of implementation of work 4 months should be conducted and at the end of November, 2015 start of a system in commercial operation was planned.

February, 2016

Program screenshot in test mode (2015)

On February 20, 2016 the Akelon company announced completion of works on the project of development in Praxair company of a management system of the registering documentation of the pharmaceutical quality system on the Directum platform.

During the project instruments of automation of collecting and the consolidated storage of registration files on products of medical appointment according to the GMP standard and the order of the Ministry of Industry and Trade No. 1997 "About the approval of Recommendations about production organization and quality control of medicines" are created.

May, 2016

In May, 2016 the Akelon company announced completion of works on development of instruments of automation of collecting and storage of registration files on products of medical purpose of two production sites of the Praxair enterprise - on products of medical oxygen of Praksayr Volgograd LLC and laboratory of quality control of JSC Volgograd Oxygen Plant.