GxP Quality Auditing

We can conduct audits for:

- Routine internal audits against regulatory standards of GMP and GCP

1. -Inspection readiness / 3rd Party Audit preparation and support
   

2. -Gap analysis audits to build focussed compliance improvement programmes
   

GxP Quality Systems

We have experience across the Development to Operations Value Chain, covering Regulatory Affairs pre & post approval, Clinical, through to front-end GMP operational management.

What differentiates us is our ability to build Quality Management Systems Thinking across the drug development through to manufacturing interface. To build your Quality Road Map for processes and controls from regulatory affairs submission & approval, document & records management & control, registration status management & tracking - right to the releasing QP - multiple interfaces all requiring customer satisfaction.

Compliance Improvement

Whether you are major Pharma or small research unit, we are able to evaluate your minimum QMS requirements and recommend and implement improvements that will deliver inspection readiness, 3rd Party Audit approval or internal requirements.

1. •For example, we recently supported a small clinical research unit to prepare for a GCP Sponsor audit; we were able to conduct a GCP gap-analysis, chair the audit-preparation meetings, align SOPs for improved process management, develop a risk-register, so that the client unit had a clear benchmark of their GCP capability and received a successful Sponsor audit.
   

Compliance Leadership - Independent, Authoritative

QMSPharma has the leadership experience and knowledge to take on the strategic Quality Roles of Chief Quality/Compliance Officer / non-Executive Director, required by such as ISO9001 / ICH Q10 and Corporate Governance models.

1. •Are you a small-medium Pharma who wants to focus on building your portfolio, but don’t have the know-how or resources to employ a full-time Quality role, or need an interim Quality Lead for a large-scale programme?
   

2. •Why not outsource this key role to us? We have the experience of implementing a fit-for-purpose Quality Governance operating model that would meet such as ICHQ10 and other QMS models.
   

3. •We can lead the implementation of your new QMS, project-manage Quality Management Plans, Chair Quality Compliance Committees with full independence - which would certainly leverage your corporate governance processes.
   

4. •Our experience is in both ‘in-house’ and ‘transitioning’ activities to new / outsourced models - including setup, tools, practical advice, audit and oversight for quality management, all of which underpins the programme during that vital transition stage to reach steady state.
   

QMS Pharma have the knowledge, experience and know-how to deliver simple, effective end to end Quality Management Systems across all these interfaces - whether for one department or one company.

1. •Do you want to differentiate to win service contracts to major Pharma?
   

2. •Do you want to simplify your processes to achieve a competitive cost-base?
   

3. •Do you want to reduce risk, reduce waste and improve customer satisfaction?
   

4. •Do you need us to lead your compliance governance?
   

Email us now for a free consultation on our services and ideas!