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Körber: Data integrity: security through reliable data
Körber can support pharmaceutical companies in achieving best-practice data integrity: ensuring their data are secure and reliable to boost their productivity and achieve faster time-to-market.
The relentless rise of digitization and automation in the life sciences industry for years has generated ever increasing quantities of data that now forms the basis for all decisions, including those with profound effects on product quality and patient safety.
Data integrity in pharmaceutical industry
Because the pharma company and patients must be able to rely on products at all times, data integrity is paramount. It is also a business enabler in making faster and better decisions.
Data integrity is rooted in the concept that if the original data is flawed, everything built on that data is fatally compromised. In a world where almost all products and services now have some data components, this is the most compelling argument for making data integrity a business priority.
“Inadequate data integrity is a threat to companies. We identify risks and point out ways to mitigate them,” says Stefan Münch, Körber’s Business Director for Validation & Quality Management.
Körber’s experts can help pharma clients to master this complexity, to comply with regulatory requirements, and to maintain complete, reliable, correct, and consistent data.
Körber data integrity validation
Körber’s consulting team can analyze and evaluate clients’ existing data integrity maturity to detect potential weaknesses and risks and to define appropriate measures for improvement. Körber’s services are based on expert knowledge of the regulatory requirements of leading international institutions, including the US Food and Drug Administration (FDA), the European Medicines Agency (EMA), the UK-based Medicines and Healthcare products Regulatory Agency (MHRA), the World Health Organization (WHO), and joint Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S).
The Körber data integrity service delivers a series of benefits:
- Using the industry´s best practices to evaluate and optimize your processes
- In-depth and up-to-date knowledge of the relevant regulatory requirements of the FDA, EMA, MHRA, etc.
- Execution of Data Integrity Maturity Assessments to quickly identify potential gaps
- Support for audit and inspection readiness on data integrity through the definition of action and risk mitigation plans
- A pragmatic approach for effective and sustainable results, carried out by highly experienced practitioners
ALCOA in pharma and ALCOA+
Data integrity in pharma guidelines are codified by a plethora of standards and regulatory bodies, including FDA, NIST, IEEE, EU and MHRA. However all are based on ALCOA: an acronym for the original five principles of data integrity.
Körber’s methodology is aligned with the original ALCOA principles that data should be attributable, legible, contemporaneous, original, and accurate, as well as with the expanded ALCOA+ guidelines that emphasize that data should also be complete, consistent, enduring, and constantly available.
Under GxP standards, the ALCOA+ principles apply to all data records: electronic, paper-based, visual and audio.
Just as firms must document the entire batch history, they must also document requirements, such as written specifications for materials or directions for procedures. Firms must also document each change within the reporting requirements that are handled through change control management.
The change control management in pharma must cope with practical and everyday needs to redefine, modify, enhance, or cancel product features in step with scientific and technical development or in response to changing legal or business requirements. In practice, this requires a review and authorization procedure to maintain the system’s validated state.
Change control programs are considered essential elements of pharmaceutical quality assurance systems. Annex 15 of the EU GMP Guidelines defines “change control” as:
“A formal system by which qualified representatives of appropriate disciplines review proposed or actual changes that might affect the validated status of facilities, systems, equipment or processes. The intent is to determine the need for action that would ensure and document that the system is maintained in a validated state.”
Verification – IQ/OQ/PQ
Data integrity also extends to system qualification, including Installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ).
Körber data integrity services include IQ/OQ and PQ services that support firms to achieve and maintain a compliant system. The service assures full compliance and validation with system documentation in approved formats.
The data integrity service is part of a wider Körber Pharma Consulting portfolio of validation services that addresses the full range of regulatory challenges for pharma, biotech, and medtech companies, including:
- Risk management with a risk-based validation approach
- Analysis of the Quality Management System (QMS) regarding validation processes
- Creation of validation strategy and implementation plans to support projects
- Computer System Validation (CSV), including equipment and system qualification
- GAMP® 5 based solutions, using V-model or alternative procedures to suit customer-specific applications
- Creation of Standard Operating Procedures (SOPs) and training management
- Complete audit management and support
- Support for validation of the cloud solutions Infrastructure as a Service (laaS), Platform as a Service (PaaS), and Software as a Service (SaaS)
- On-site support and implementation.
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