INOVAÇÃO

Perseguimos s...

CSV (GxP)

Computerized Systems Validation...

AUTOMAÇÃO INDUSTRIAL

Especialistas em A...

SOFTWARE

À sua ...

SOLUÇÕES WEB

Desenvolvemos à ...

SMS

Comunicação, Marketing e ...

ENGENHARIA DE SISTEMAS

Projecto e ...

http://site.pse-engineering.pt/components/com_gk2_photoslide/images/thumbm/369247untitled.JPG
http://site.pse-engineering.pt/components/com_gk2_photoslide/images/thumbm/301406New_Picture__4_.png
http://site.pse-engineering.pt/components/com_gk2_photoslide/images/thumbm/719848New_Picture__5_.png
http://site.pse-engineering.pt/components/com_gk2_photoslide/images/thumbm/384600New_Picture__7_.png
http://site.pse-engineering.pt/components/com_gk2_photoslide/images/thumbm/269931New_Picture__9_.png
http://site.pse-engineering.pt/components/com_gk2_photoslide/images/thumbm/840066New_Picture.png
http://site.pse-engineering.pt/components/com_gk2_photoslide/images/thumbm/654754New_Picture__8_.png
News Image

INOVAÇÃO

Perseguimos soluções...

News Image

CSV (GxP)

Computerized Systems Validation ...

News Image

AUTOMAÇÃO INDUSTRIAL

Especialistas em Automação...

News Image

SOFTWARE

À sua medida...

News Image

SOLUÇÕES WEB

Desenvolvemos à medida...

News Image

SMS

Comunicação, Marketing e Automação...

News Image

ENGENHARIA DE SISTEMAS

Projecto e Desenvolvimento...

About Our Company

PSE – Consultoria e Engenharia de Sistemas is a young company which combines dynamism and experience. Its main goal is to meet the specific needs of its clients by anticipating problems and presenting resourceful solutions.

PSE is an engineering company which gathers a multidisciplinary team of highly qualified collaborators. This group’s success arises, mostly, from an outstanding interpersonal relationship amongst team members and from the harmony between individual expectations and company’s values.

This company builds on our collaborators technical expertise and experience in diversified areas, such as Industrial Maintenance, Automation, Custom Software and GxP Computerized System Validation (21 CFR part 11, GMP).

 
GxP Excel SpreadSheets Validation

The FDA regulations and EG-GMP-guideline commits pharmaceutical companies with an additional guideline to validate their computational systems if these are integrated in GMP-areas as the production, warehousing, sales department and quality control.

FDA regulations and the EG-GMP-guideline provide an additional guideline to pharmaceutical companies  obliging them to validate their computational systems when the latter are integrated in GMP-areas, such as production, warehousing, sales department and quality control.

Included into computer based systems are Microsoft Excel Applications as these are regularly used in QC and QA for calculations and evaluation of data.

Microsoft Excel Applications are also included into computer based systems because they are regularly used in QC and QA for calculations and data evaluation.

PSE will ensure that: 

    * Excel spreadsheets are based on cGMP.

    * Development, organization and documentation of Excel applications are controlled.

    * Standard requirements concerning GMP are well known and followed.

    * Required tasks () are () elaborated and responsibilities are assigned during the validation process.

    * Excel sheets support and assure achieving top quality  products; additionally the operation of the used systems is adequate concerning GMP guidelines.

Excel sheets do not only support the fabrication of top quality products, but they also assure it; additionally, they guarantee that the operation of systems is adequate concerning GMP guidelines.

The development and validation of Excel spreadsheets in a GMP-compliant way, performed by PSE, are on the current and sophisticated level of available technique. We ensure that your excel spreadsheets comply with all legal requirements and guidelines, such as: 

    * Annex 11 – EU-GMP – “Computerized Systems”

    * Annex 15 – EU-GMP – “Qualification and validation”

    * 21 CFR Part 11 – “Electronic Records; Electronic Signatures”

    * PI 011/03 – “Good Practices for Computerized Systems in Regulated ‘GXP’ Environments”

    * GAMP 5 – “A Risk-Based Approach to Compliant GxP Computerized Systems”
 

  Main features of an Excel Spreadsheet development and validation:

-       Labeling of entry cells;
-       Use instructions;
-       Color differentiation for input and output cells;
-       Data Validation on input cells;
-       Description of formulas printout; ? Printout with the description of formulas
-       Acceptance criteria for final result;
-       Print date, excel file path and spreadsheet name on footer.
-       Specification of the function, including detailed specification for the    creation of formulas used for calculations if necessary;
-       Regulations concerning an explicit classification of the Excel Spreadsheet version;
-       Regulations concerning a control and authorization of each particular Excel Spreadsheet version;
-       Documentation of formats, conditional formats and validity tests of cells;
-       Documentation of the cell protection;
-       Explicit storage folder of these files;
-       Operators training;
-       Change control;
-       Version control;
-       Secure formulas;
-       Secure spreadsheets;
-       Mechanisms against unauthorized access;
-       Secure workbook.

 
Consupl@n

Consupl@n is an integrated tool for private practice management which is meant to facilitate all data treatment related to doctor appointments: it enables a faster and more efficient control over the gathered information, and it includes advanced services of communication with the patients. 

The health sector is highly competitive, that is why the investment on the excellence of customer service is essential. Private practice serves a demanding market, which pays good money for quality service, and quality greatly depends on the efficacy of the communication with the client.

With Consupl@n you can effectively explore communication channels via SMS (Short Message Service) which offer advantages such as the reduction and rationalization of costs and the increase of revenues.

Through this tool, your office, laboratory or clinic can be in direct contact with patients by using SMS, since it enables communication in a reliable, fast and discrete way, without disturbing your client. 

This application also permits a centralized management of the patients’ database, the scheduling of messages or notices to remind patients of the date and time of their appointments, among other services which are crucial to the good performance of your team.
 

For more information go to www.consuplan.pt. English version available.

 
Our Services

§        Development and Computerized System Validation (GxP)

§        Excel Spreadsheets Development and Validation (GxP)

§        Industrial Automation

§        Custom Software

§        Web Design

 
Our Mission

Our mission is to achieve a broad scope of intervention, which comprises the diverse technological areas in which we are technically competent and whose supply in the Iberian market is scarce, providing our customers with high quality products and services. 

In our company, team spirit and team work are fundamental values upon which are built our technical competence and work on behalf of the client.

In this context, our clients, partners, suppliers, co-workers and the community can rely on our loyal attitude, on the fulfillment of our engagements and on the achievement of our goals, always respecting confidentiality.

Creativity is another one of our most treasured values. We seek to offer a competent, quality service with inventiveness and inspiration. We are on a permanent quest for innovations and improvements and we work incessantly to apply them with haste. We set challenging goals and pursue high performances.

 

 
João Ferreira
"A equipa é fantástica e competente. O resultado final do projecto superou todas as expectativas iniciais"
Maria Fernandes
"Conseguimos uma visibilidade relevante com o nosso website e com os modelos de campanha de marketing por SMS "
Carlos Ribeiro
"A PSE é um parceiro indispensável em automação e software à medida."

Opinião

O que pensa do nosso website?
 

Home | RSS Feed | All rights reserved ©2010 PSE - Consultoria e Engenharia de Sistemas | CSS | XHTML

Top