 |
PAS-X Business Functions
|
|
| CORRECTIVE & PREVENTIVE ACTIONS |
|
| Quality Assurance based on the CAPA Strategy |
|
CORRECTIVE & PREVENTIVE ACTIONS
is a web-based PAS-X business function for quality assurance in the pharmaceutical industry, and is based on the CAPA strategy. The software helps you continuously improve the quality of your products and processes. Werum has developed the application in cooperation with Bayer Technology Services.
Definition Corrective and Preventive Actions
The acronym CAPA stands for Corrective and Preventive Actions - an instrument of integrated and comprehensive error management. The core element of the CAPA approach is the effective and systematic processing of quality deficiencies, errors, and malfunctions, with the aim of making appropriate corrective actions and consistently preventing recurrent breaches of compliance. The CAPA strategy has been developed by the American Food and Drug Administration (FDA) for the inspection of medical products. This procedure has quickly become established as one of the most important Quality Systems to be applied within the scope of Quality System Inspection Techniques (QSIT). The practical implementation of CAPA has led to a measurable reduction of non-compliance rates in the medical products industry.
Further information on CAPA (external):
FDA CFR 21 Part 820 (Quality System Regulation)
FDA guidance (PDF)
"Quality Systems Approach to Pharmaceutical cGMP Regulations"
|
|
|
|
| Benefits |
|
|
With the help of CORRECTIVE & PREVENTIVE ACTIONS, all actual and potential product and process
non-conformities are registered and assessed. CORRECTIVE & PREVENTIVE ACTIONS facilitates the
analysis of trends based on the collected data, and provides the user with all the information
required to set up efficient corrective action plans. The system documents and archives all the
data in compliance with GxP requirements - from a deviation registered in production or a customer's
complaint, through to the definitive action taken, along with a final evaluation of its effectiveness.
CORRECTIVE & PREVENTIVE ACTIONS therefore monitors the quality of the products and processes from
distribution through to delivery to the final customer - along the entire supply chain.
|
|
| Fields of Application |
|
|
|
CORRECTIVE & PREVENTIVE ACTIONS
primarily involves those employees responsible for quality assurance, quality control, regulatory affairs, and manufacturing processes. This application provides an efficient means of collecting, assessing, and documenting deviations from out-of-specs, revisions, customer complaints, investigational findings, change requests, and the ensuing corrective and preventive actions in compliance with regulatory requirements. Overall, the processes for deviation and complaint management become more transparent and efficient, and thus more effective. Conventional, manual, paper-based methods are comparatively slow, inefficient, and prone to mistakes. As such, they carry the risk that detected errors are only partially tracked and that regulatory requirements are not sufficiently followed.
|
|
| Functions |
|
|
CORRECTIVE & PREVENTIVE ACTIONS covers three functional groups:
- Deviation Management
- Complaint Management
- Corrective and Preventive Actions
 enlarge
|
|
| Advanced Application Functions |
|
|
- Individual notification paths (e.g. email)
- Linking of external documents
- Monitoring of due dates and deadlines
- Global monitoring of all measures taken
- Comprehensive query and filter functions to facilitate retrieval of information
|
|
| Technical Features at a Glance |
 Top of Page
|
|
enlarge
Form for the capture of deviations
|
Web-Based System
The user captures the data using self-explanatory, web-based forms. Even users who rarely process deviations and complaints can easily master this task.
Convenient elementary functions
The elementary functions of CORRECTIVE & PREVENTIVE ACTIONS involve
user and address administration as well as master data management, and
also include functions for data evaluation and creating reports
(e.g. with Crystal Reports).
Parameterizable Workflows
The defined standard workflows can be configured by the user in a very flexible way.
Regulatory Compliance
The mapping of workflows is based on a roles and rights concept which - in combination with the required electronic signature and an audit trail function - implements all the standards of current Good Manufacturing Practices (cGMP) and 21 CFR Part 11.
Multi-Language Capability
CORRECTIVE & PREVENTIVE ACTIONS has been designed as a multi-language system in order to facilitate global system deployment.
|
|
|
| Integration and Interfaces |
|
|
CORRECTIVE & PREVENTIVE ACTIONS can either be used as a stand-alone software system, or as an integrated package within the PAS-X portfolio.
CORRECTIVE & PREVENTIVE ACTIONS is equipped with interfaces to:
- ERP systems (e.g. SAP)
- MES packages from other suppliers
- E-mail systems (e.g. Lotus Notes)
- Document management systems (e.g. Documentum, FileNet)
|
|
