Quality

Q2S, Quality as a Service -
Long term Collaboration (Assignment)

Provide the following services:

• Hire of QP (Qualified Person)
• Hire of Responsible Person (Distribution of pharmaceuticals)
• Hire of department QA / QC Managers
• Hire of project QA Managers
• Hire of Quality Engineer (e.g. Complaint investigations, Risk Management, Change Management)
• Analysis and Reporting – PQR, APR etc.

Provide management and responsibility of a QMS:

• Develop and Maintain a compliant QMS

Compliance

Audit services

EU GMP, GDP, Medical Devices

• Suppliers, Laboratories, internal QA/QC departments, CMO/CRO
• distributors, repackers, transport companies of pharmaceuticals
• EU GMP, EU GDP, MDD/MDR, ISO 13485, 21CFR820, 21CFR210
• IT Processes, In-house IT departments, Software Development Processes
• Due-diligence of QMS organizations and processes

QMS related services

GAP analyses, Establishment, reconstruction, extension of QMS systems

• EU GMP, GDP, MDD/MDR, ISO13485, 21CFR820, 21CFR210 or other regulatory requirements

Validation and qualification services

• Manufacturing, laboratories, administrative systems, HVAC etc.

Serialization and aggregation
Services related to clean rooms / sterile environment

Security

Information Security related services

Records and Information Management

• Routines for Regulatory and Business Critical information

Data Integrity

• Data integrity is a prerequisite for the regulated healthcare industry

GDPR

• Establishment of GDPR framework
• GAP analysis / Improvement of GDPR processes

Project Management

Senior Project Managers

IT system introduction / roll out, e.g.

• SAP R/3
• Movex M3
• EBR
• LIMS
• HR & Payroll

Serialization and aggregation projects

Product Lifecycle Management (PLM)

• Initial conception
• Design control (R&D)
• Industrialization
• Product care
• Product decommissioning

Remote Audits

Why remote audits?

According to current regulations, an audit of the supplier is usually needed as part of the supplier qualification. When the world situation is as it is with travel restrictions, many of these audits cannot be performed. This can be solved with a remote audit, which can be seen as a paper-based audit but with the addition of performing parts of the audit via a web meeting. Many authorities and NB have already switched to this type of inspection. Further benefits of remote audits are that they usually become cheaper (no travel costs) and, if necessary, more auditors can participate (eg experts).

Bruun & Maté has developed a "best practice" on how a remote audit can be done. The main steps are:

1. A risk assessment is performed in collaboration with the customer to evaluate what is important that it is ensured during the audit.
2. A detailed audit plan is prepared and sent to the supplier to ensure that they have the right people in place and have the necessary technical equipment.
3. The remote audit is conducted based on the risk assessment and the documents obtained from the supplier before the audit.
4. An audit report is compiled and the risk analysis is updated with the results of the audit. An assessment is made of whether a subsequent on-site audit needs to be done when it becomes possible to travel again.
5. If an on-site audit is considered necessary, it will be done in areas that could not be inspected during the remote audit. This means that this will be a shorter audit focusing on the areas that need further review according to the risk analysis.

We have several senior auditors who can tailor a solution to suit your needs. If you want help with an audit, please contact us.