CAPA MANAGEMENT

Quality process

Corrective and Preventative Actions (CAPA)

CAPA is an excellent Quality Management tool to continuously improve processes and avoid future failures.  All personnel involved in the management of deviations and in CAPAs should aim to identify opportunities for further improvement.To understand how to achieve quality in a regulated industry, you need to know that corrective and preventative actions (CAPA) are essential elements of quality management in GxP environments. The CAPA process is a commonly used tool to achieve operational excellence by identifying and mitigating non-conformances and deviations, both internally and externally. 

The process consists of two key elements: corrective actions and preventative actions. Corrective actions give you the structure in finding root causes of problems and solving those problems. However, preventative actions, like documenting the conditions and solutions for the future, implementing measures for these problems and proofing the effectiveness have a direct impact on the risk profile of a company.

  • Event Mapping / Audit Scheduling
  • Structured Problem Analysis
  • Multidimensional (facetted) Search
  • Smart Follow-up Workflow
  • Effectiveness Check
  • Indicators and Signals

For companies in the life sciences industry a comprehensive quality system which is monitored carefully is critical to stay in business.

 

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The requirements for a risk-based CAPA demand beside a well-documented system which keeps root causes of non-conformances, system failures or process problems on record, include a solid process that corrects the problems, and also prevents them from recurring.

The documentation must identify why something went wrong, or why it may go wrong, and what has been done to ensure that it will not happen again.

CAPA systems can be seen as evidence for  problems and of the company's capability to resolve problems in general. In that way these systems are a preferred target and typically scrutinized at audits or regulatory inspections.

Related Processes

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Audit Management

The increasing complexity and continuous changes in the regulatory environment push organizations to seek a more holistic and highly integrated approach to their audit management processes. Auditing is a vital function within a pharmaceutical company.

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CAPA Management

To understand how to achieve quality in a regulated industry, you need to know that corrective and preventative actions (CAPA) are essential elements of quality management in GxP environments. The CAPA process is a commonly used tool to achieve operational excellence by identifying and mitigating non-conformances and deviations, both internally and externally. 

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Change Control

Change management is specifically designed to evaluate, redesign, and implement new business processes, where processes are defined in standard operating procedures (SOPs). A well implemented change management rewards the company with improved business processes, efficient workflows, decreased project overhead, a better risk profile and an improved company culture. 

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Deviations Management

The management of deviations is not just a GMP concept, it spans the entire product life cycle, including Good Laboratory Practices (GLP) and Good Clinical Practices (GCP) and Process Deviation Management.

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High Content Screening

High-content screening (HCS), also known as high-content analysis (HCA) or cellomics, is a method that is used in early development stages and drug discovery to typically identify substances such as small molecules, peptides, or relevant RNAi that can lead into development candidates for future medicines. 

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Image Annotation

With the development of diagnostic imaging devices, large amounts of digital high-res and 3D images are generated every day. The requirements of effective indexing and searching image are growing rapidly. Image annotation is an effective way for content-based image retrieval. 

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CRO Collaboration

The last few years have seen tremendous consolidation in both the pharmaceutical and contract research industries. The impact among pharma companies has created a heightened demand for productivity. 

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Remote Image Analysis

Imaging data in diagnostics and research is growing at an unprecedented rate, coming from all kinds of sources. The con-focal and high-resolution microscopy, artificial intelligence, and any other new computer-tomographic (CT) technologies create vast amount of data. When researchers start to collaborate over distances with imaging centers, using diagnostic services over internet connections, the bandwidth and computation power easily exceeds the capabilities in remote areas. 

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Inspection Management

Regulatory agencies conduct routine inspections during active studies. In this case, documentation must be available and complete, ensuring that the study was conducted following the protocol using the principles of Good Clinical Practices (GCP).

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SOP Management

Life science organizations developing or manufacturing pharmaceutical products will typically create, maintain and execute large amounts of standard operational procedures (SOP). The solid change control and deployment of SOPs are a fundamental to achieve compliance excellence.

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Raw Data Management

A clear understanding of how RAW DATA is defined, recorded, and retained in the laboratory record is essential when it comes to compliance with the Good Laboratory Practices regulations. RAW DATA in laboratories occur in various fluctuating formats and versions in a large amount of laboratory devices, LIMS and quality management systems. 

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Training Management

Post implementation training services relate often to process changes. With training services implementations are ready for success. The Learning Management System (LMS) typically handles the processes related to ramp-up and adoption planning after larger implementations. 

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eTMF and Archiving
To comply with regulatory government policies, clinical research organizations need to keep records of essential documents that are stored in the trial master files (TMF). The TMF allows independent auditors and regulatory authorities to monitor and evaluate the quality of the data produced by a clinical study.
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INDUSTRIES

Biotech

The broad concept of “biotechnology” or also known as "BioTech" encompasses a wide range of procedures. The global market for the biotechnology market is primarily driven by technologies like DNA sequencing, nano-biotechnology, tissue engineering and regeneration, cell-based assay, PCR technology, and others. Explore the flexible solutions for emerging BioTech

 

Pharma

The pharmaceutical industry develops drugs or devices to diagnose, cure, treat or prevent diseases. Pharmaceutical companies produce both generic and branded drugs. Pharmaceutical drugs are subjected to various laws and regulations that deal with patenting, testing, safety, efficacy and marketing. Pharmaceutical drugs are intended for human or veterinary use presented in their finished dosage form. Learn more about the Process excellence of biomedion in Big Pharma.

 

CRO

A contract research organization (CRO) is a company that offers services to the pharmaceutical and biotechnology industries. These companies partner with various companies and organize and conduct clinical trials to test the new molecule before obtaining approval. Contract manufacturing organizations (CMO) offer manufacturing services, with volume capabilities ranging from small amounts for preclinical R&D to larger volumes necessary for clinical trial purposes and commercialization. See how biomedion enables functional service provision with CROs.

 

CMO

A contract manufacturing organization (CMO) is an organization that serves the pharmaceutical industry and provides clients with comprehensive services, from drug development to manufacturing. Outsourcing to a CMO allows the pharmaceutical clients to expand their technical resources, without increased overhead. Arivis offers solid solutions for contract manufacturing.

 

GLP Laboratory

Third-Party Laboratories for GLP Testing, contract testing laboratories. Pharmaceutical manufacturers contract out any quality control testing, will need a licensed laboratory, certified as a GMP or GLP. The GLP laboratories are designed to protect scientific data integrity, and to provide the EPA or FDA with a clear and auditable record of open-ended research studies. With a biomedion you are committed to integrity with contract testing laboratories.

 

Diagnostic Microscopy

Microscopes have enabled researchers to conduct in-depth academic and exploratory research. The biomedical research and engineering sector is driving innovation by microscopy techniques to produce better and more informative images of cellular functions, including internal images of cells.