Quality Management Solutions
Quality Management System Design
At Widler & Schiemann, we understand that the scope of your QMS system depends on your sourcing strategy, so we always begin with an assessment of your organization to define the scope of your internal structure and identify current capabilities as well as potential growth opportunities.
With more than 350 SOPs and supporting documents available for customization, WS can provide you with the expertise you need to meet your project deliverables.
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To support SOP and documentation template development, we offer a variety of approaches:
1. Review of existing SOPs against current guidelines and organizational scope.
2. Update existing SOPs or provide missing SOPs in either client or WSQMS format
3. If no company SOPs are available, WSQMS can provide a "starter kit" of SOPs in client or WSQMS format.
4. The same starter kit can also be licensed, which means the SOPs are automatically updated when and if there are regulatory changes.
Project Approach
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Collaboration & Evaluation
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Gap Analysis & QMS Design
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SOP Delivery
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Training Program/Process Improvement
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Extended SOP Support
Quality Management Services
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WSQMS can support you with a comprehensive suite of Quality Management services, including:
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development of a quality strategy
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an annual audit plan
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a quality risk management assessment
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CAPA Management
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Health Care Compliance
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compliance training
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advice on GxP related issues
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These can be provided as individual services supporting your existing company QA or by WSQMS providing a dedicated Head of QA, specially trained in working with start-up companies
Audit
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Global coverage: With our strategic locations and our network of GxP experts and auditors, we can offer audits in all relevant countries
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Focus areas: All quality aspects, including GCP, GVP, GMP, GDP, GLP and ISO13485
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Types of audits: Vendor and Site qualification audits, Sponsor’s internal audits, Vendor and site compliance audits, TMF QC/ completeness audit, Clinical Study Report audit, "for cause" audits
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Approach: An audit plan will outline the scope of the audit and align expectations from sponsor and auditee. After completion of the audit, a comprehensive audit report will detail all findings and recommendations to improve compliance
Inspection Readiness
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QMS Gap Analysis: Review of current and future GxP processes to ensure regulatory compliance as drug development company and Market Authorization Holder.
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TMF Review: Assessment of the pivotal clinical trial(s) documentation
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Mock Inspection: Review, preparation and training of the organization for an inspection by FDA, EMA, MHRA, PMDA, NMPA, including mock inspections on the sponsor, selected vendors and selected clinical sites. An assessment report will indicate all relevant findings and CAPA’s to address.
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Inspection Training: Dedicated training to prepare the Sponsor inspection team and the investigational site(s) for the upcoming inspection (do’s and don’ts)
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On-site Inspection Support: Hands-on support for the duration of the inspection and review of inspection requests and responses.
