QMS Software Features

Our GMP/GDP QMS Software has a great number of amazing features for every organization.

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Features

Due to the flexibility of the software you could integrate any element of your quality management system in PCS Intelligence. Nonetheless we have established a baseline of features:

Multi-Device Support

The full application is available on any type of PC/Workstation or Laptop running Windows. Tablet support allows operation in controlled environments. Using PCS Intelligence Connect you can use the mobile application on the go.

Document Management

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.

Workflow Management

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.

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.

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.

E-Mail Integration

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.

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.

Centralized Outsourcing 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.

Standardized GMP & GDP Documents

A few examples of the documents that come standard with PCS Intelligence:
  • Deviations SOP
  • Change Control SOP
  • Management Review SOP
  • Periodical Risk Inventory SOP
  • Training SOP
  • Training Logbook
  • Complaint SOP
  • Out-Of-Specification (OOS) SOP
  • Investigations SOP
  • Supplier Management SOP
  • Self-Inspection SOP
  • Missing Goods SOP
  • Returns SOP
  • Recalls SOP
  • External Audits SOP
  • Internal Audits SOP
  • Batch Number Registration SOP
  • Counterfeit Medicine SOP
  • Licenses SOP
  • CAPA SOP
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