Quality (& Workflow) Management System Software
For the pharmaceutical industry.
What is PCS Intelligence?
PCS Intelligence eQMS Software is, in essence, a workflow management system that is robust, flexible and has been in development since 1993. It contains easily adaptable elements such as centralized procedure distribution, review and approval of procedures, roles & authorizations, training records and procedures such as Change Control, Deviations and Out-Of-Specification (OOS).
The software is so flexible that it requires zero coding to amend the worflows and procedures to your situation. It can read and write Word documents, PDF and Excel files (to name a few). The software even allows you to integrate your email to make sure that complaints, recalls and so forth are processed in a timely manner.
Due to the flexibility of the software we could integrate any element of your quality management system in PCS Intelligence. Nonetheless we have established a baseline of features:
- Workflow Based on SOP's such as Change Control, Deviations, CAPA, OOS, etc.
- Centralized User Access Control (UAC)
- Modification and creation of Word/Excel/PDF documents based on your lay-out
- Centralized review, approval and distribution of SOP's and other documents
- Full E-mail integration and processing based on e-mail contents
- Forms with input checks (validation) for critical data
- Connect to monitoring equipment/balances/etc. for data input & review
- Annex 11 & 21CFR11 validated software
To learn more about the advantages of PCS Intelligence eQMS Software click here.
Single user licensing starts at € 225.- per month. However, we only count concurrent users. And the best part is, we don't restrict access when you need an additional person using the system for a brief period of time. Volume discounts apply. Enquire with PCS for more information on volume discounts.
For more information contact PCS by following this link. Or simply use the form below to get in touch with us.
PCS Intelligence Advantages
All information required for process execution is brought together with PCS Intelligence at one central point and visualized in an advanced manner. The system can be set up by the organization itself and everything takes place on a secure, GMP validated and ISO certified platform. Relationships, dossiers and activities are successfully brought together in one system that is available 24/7. The package is flexible: it grows with organizations and gives space to their activities and growth ambitions. Promis increases the efficiency and effectiveness within the business operations of entrepreneurs and provides transparent and accessible process information to all users of the system.
Centralized Contact Management
Registration of (among other things), address data, company and personal data is centralized in PCS Intelligence. This prevents mistakes and realizes a huge efficiency improvement. If you use a so-called VOIP exchange, incoming calls can be immediately identified and linked to files and stakeholders. You can also call phone numbers from PCS Intelligence directly from the screen. This means maximum service for your customers, vendors and other stakeholders.
Automated Quality Assurance Monitoring and Control Tool
A full audit trail allows all user actions to be monitored, standard processes can be activated automatically, monitored and reports of the monitoring decisions can be made available. This ultimately means that events such as deviations are processed within the expected timelines and according to your procedure. Desired changes can be implemented flexibly by yourself and do not require explicit software adjustments or customization from the supplier of PCS Intelligence. The Automated Quality Assurance Monitoring and Control Tool uses formulas, form checks and so forth to base its decisions on without requiring any programming effort.
Capture and manage all forms of attachments such as photographic records of settle plates. Attachments can be secured from modification or deletion to comply with the Data Integrity requirements for electronic Quality Management Systems.
All incoming documents can be digitized using any scanner. There is also the possibility to intelligently process scanned documents. This means that everything is always immediately available and can even be offered automatically to relevant stakeholders within your processes.
Management Review Information
Dashboards and management reports can be made available in PCS Intelligence. This means management can be provided with an overview of relevant, steering information on the basis of which direct decisions can be made. When you connect digital equipment such as balances or thermometers you can monitor your CQP's and CQA's.
Organize workflow management according to your own wishes. Herein, all individual processes, such as CAPA, Deviations, Out-Of-Specifications (OOS) and follow-up systems (dynamic) can be defined and automated. Related to this is also the fully automated processing of documents which are associated with these processes. These can also be made depending on types of assignments, whether or not in combination with stakeholders. This means that the system ensures the correct procedure is followed and actions are not forgotten.
PCS Intelligence Connect
A module that makes it easy to integrate with other data sources. This means for you an easy connection and access of data to e.g. mobile platforms and third-party systems.
With this module not only e-mails are processed in the usual way but complete and simple integration takes place with all functional components of PCS Intelligence. The mail module uses all known and available mail servers, such as Microsoft Exchange and Gmail. This means that all your incoming and outgoing e-mails are stored correctly and in the right place so that they are always, directly and simply available to everyone who is authorized to use/view them.
The agenda module allows you to, for example, plan and oversee all actions of your employees. Employees can also be scheduled immediately to take over current matters from their colleagues, for example during holidays, peak days when there are many batches to process or illness.
User Access Control (UAC)
Extensive authorization options according to Annex 11 and 21 CFR 11. This means that you can set up the system in such a way that you can determine who can view or change which information and when centrally.
Proven Track Record
- Serum Institute of India (Pune). Support in the design and construction and implementation of quality systems for three new buildings including two vaccines and one sterile finished dosage form. FDA approved.
- Assistance in start-up and quality systems for Protein Sciences (Meriden U.S.). FDA approved.
- Long-term support for Boehringer Ingelheim IT, (Biberach, Germany). FDA approved.
- Long-Term QA support for Roche (Mannheim, Germany). FDA approved.
- WHO Prequalification audit and support for Yuxi Walvax (China).
- Acambis (Cambridge U.S.) QA support in startup and operation of a vaccine manufacturing plant. FDA approved.
- Genibet (Lisbon, Portugal). Design Qualification of a Biotech Manufacturing facility and QA support to Licensing. EU approved.
Our consultants have performed a significant number of assignments globally, in a range of different industries.
We are a dedicated team of consultants who know all ins and outs of Quality Systems and its potential issues.
Our consultants work in a great number of companies across the pharmaceutical industry as Subject Matter Experts.
Overview of Our Services
Click here to contact us if the service you require is not listed below.
- GAP Analysis and Benchmarking
- Risk Assessments of (Proposed) QA Systems
- Development of Pharmaceutical Quality Systems & Quality Culture
- Definition of Suitable Metrics for Quality Monitoring and Improvement
- Practical Implementation Support of Entire Quality Systems or parts thereof
- Coaching and training of personnel at all levels within the organization in the principles and practice of Quality Systems
- Independent inspections to determine ongoing compliance to in-house, corporate or official Quality System requirements
- United States Food and Drug Administration (FDA)
- European Medicines Agency (EMA)
- World Health Organization (WHO) Qualification
- World Health Organization (WHO) Pre-Qualification
- Russian Good Manufacturing Practices (SID & GP)
- Indian National Regulatory Authority (NRA)
- Other National Regulatory Authorities