GDP and GMP software
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For pharma & biotech

PCS Intelligence software

PCS offers software for the pharmaceutical and biotech industry. The software, called PCS Intelligence, offers an integrated solution for digitizing quality systems, work processes and reports.

The PCS Intelligence software is designed to link, organize and provide meaning to all information within the company. Everything revolves around the three main functionalities of PCS Intelligence; dossiers, workflows and stakeholders.

Dossiers

Dossiers contain the information and what the information entails. You can see it as a meta database in which all your information can be found.

Workflows

Workflows ensure that the information is processed correctly. These workflows can be set up by the company itself.

Every workflow has a beginning and an end. In each step of the workflow, the company determines what needs to be done; fill out a form, automatically send an e-mail to an employee or run a report.

The information from the workflows is recorded in Dossiers. This information can consist of emails, files, completed forms and all kinds of other data.

Stakeholders

Stakeholders are the suppliers, departments and people the company works with (internally or externally). The actions in workflows are linked to stakeholders. Think of the quality manager, the contract manufacturer or the QC lab. Any party the company works with can be a stakeholder.

With these three components, a pharmaceutical company can digitize any work process. After all, every process consists of people, tasks and information. Whether it's automating the central distribution of procedures, managing registration files or batch record review, PCS Intelligence offers the flexibility and possibilities to painlessly digitize the process.

Why use PCS software?

PCS Intelligence is designed for the pharmaceutical and biotech industry. The flexibility to set up workflows yourself makes PCS Intelligence unique within the pharmaceutical industry. The software is suitable for small to large organizations.

Change workflows

Fully customizable workflows. You can create or modify workflows, without needing external support!

Built by experts

Built by GMP-consultants. We have seen the worst 'pharmaceutical software'. Our software avoids those mistakes and bad practices.

Operator data entry

Operators use tablets to enter data into digital forms. Ready for QA-review in a split second. Feeds data straight to PQR & MR

PCS Intelligence goes beyond standard plug-and-play software

Breaking the norm

Plug-and-play software has been the norm in the pharmaceutical industry for many years. With standardized work processes and functionalities, a pharmaceutical company can get to work immediately.

Creating new possibilities

Unfortunately, this kind of plug-and-play software sacrifices flexibility. Adaptations to plug-and-play software are capital-intensive and time-consuming. In practice, companies adapt their workflows to the capabilities of the software. That's the world upside down. PCS Intelligence is built to open up new possibilities for the industry.

Unlimited processes

Plug-and-play software is also based on a number of basic processes, such as change control, approval of procedures and deviation management. But what if you have a separate process for managing your suppliers. Can that be added? Not in most cases. PCS Intelligence offers customers the possibility to add an unlimited number of processes.

Amazing flexibility

Thanks to the flexibility of the PCS Intelligence software, it grows or shrinks according to the needs or the size of your company. Quality, production or regulatory affairs departments in particular make extensive use of PCS Intelligence.

Advantages of PCS Intelligence

An additional advantage of PCS Intelligence is that it was developed by a company that has been active in the pharmaceutical industry as a consultant and training institute for over 30 years. We've been sitting on the other side of the table all these years. We know better than anyone the pain points of pharmaceutical companies in the field of automation. We have solved these pain points in our software. The pain points we solved include;

  • User Access Control down to task level,
  • Automatic printout of PQR and Management Review reporting,
  • Automatic input checks with automated error messages and notifications,
  • Complete audit trail that can be read quickly and easily by auditors and inspectors,
  • Standardized validation package according to the EU and U.S. FDA guidelines,
  • Excellent document management functionalities with centralized document distribution, intake and authorization,
  • Keep track of whether SOPs have been read per employee,
  • Centrally collect comments/revisions on SOPs per employee,

And many other functionalities that we have incorporated into the software to make life as easy as possible for the quality department, operators and management.

PCS Intelligence, software for everyone

The software is also used in other industries where the requirements regarding data integrity and security are even stricter than in the pharmaceutical industry. The software behind PCS Intelligence is used in the aviation sector by processors of medical data and insurers. This assures PCS Intelligence customers that the security and integrity of data is thoroughly tested and guaranteed.

The software service of PCS

PCS offers help with setting up the software. This allows us to speed up the implementation process together with you. PCS also offers main user training. We teach the main users in 2 to 5 days how to set up work processes, files and the like.

After this training, the main user can almost set up the software himself. We also offer user training, in which we walk through the software together with the users and highlight practical points.

Setting up standard processes

If desired, we can also introduce a number of standard processes in advance. If you wish, a number of standard GMP or GDP processes can be prepared in the software. This is particularly useful if you do not yet have a quality system or if you wish to have a set of samples. Examples of these standard processes are; deviations, change control or CAPA processes.

Speed up the validation process

We can also help you validate the software. Although PCS provides a standard validation package, you will still have to perform a set of tests yourself to complete the validation on your side. If desired, PCS can provide specific validation knowledge and input to speed up the validation process.

Validated to
international standards

EU GMP Annex 21 - U.S. FDA 21 CFR 11 and WHO GMP validated.

EudraLex logo
U.S. FDA logo

What does the PCS software cost?

Prices for a main user start at €225,- per concurrent user license per month. Main users can change the work processes, forms, files and the other layout. Volume discounts apply when multiple power users (with concurrent license) are desired.

Standard users start at 40 euros per concurrent license per month. Standard users are users that cannot configure the software.

In addition, there are one-time installation costs of 1500 Euro. If you need help setting up or configuring the system, the support costs are 95 euros per hour.

How to get PCS Intelligence

You can send an email to info@pcs-nl.com containing a request for the software. We hereby invite you to specify your wishes. We will then schedule a demo with you. In the demo we go through the main functionalities of the software. After the guided demo, you will receive login details to get started with the software yourself. This demo period is between 14 and 30 days.

After the demo period we will set up a Proof-of-Concept (POC). We use processes, documents and other examples from your company to show how the software will work for you.

After a successful POC you will receive an acceptance environment in which the software is set up and tested. When the development is almost ready, we bring you to the production environment, this is the 'live' environment, after which the software is active.

Alternatively, fill in the form below and we will be in touch soon!

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