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  • Factorytalk

    We are proud to take care of your compliance needs and development.

  • Factorytalk

    We provide rapid returns on investment in quality.

Factorytalk: One-stop compliance services

Factorytalk's Compliance team are experts in helping the regulated industries establish efficient, cost effective quality systems that will pass inspection and produce high quality products.

We review current systems and support you through every step to become more efficient , robust and compliant to stand up to all regulatory challenges.

Compliance steps

GMP ASSESSMENTS:

Factorytalk's GMP assessments analyse all critical aspects of your project, system or facility to ensure that subsequent actions, efforts and investments to meet specific requirements (PIC/s, US FDA etc) are based on a valid assessment, data and criteria to reduce the risk of non-compliance as efficiently as possible. All methods, findings and recommendations will follow and reference directly to the stated GMP requirements based on our proven template.

  • GAP Analysis/ Audits
  • GMP Health Check

IT Strategy : We provide workshops and strategy to determine how you should apply the requirements of Computer Systems Validation and how to develop a corporate IT Strategic Plan / Roadmap that meets your Business Objectives and develops Business Cases for you required IT landscape.



PLANNING SERVICES:

  • User Requirement Specifications: Created by combing a standard and well utilised template together with workshops, high-level business process mapping / re-engineering and selected interviews to ensure that the URS sufficiently documents functional and regulatory requirements and re-engineered to-be processes.
  • Facility / Utility Monitoring: A design review to ensure best engineering practice and GMP requirements are all included in an optimum layout.
  • Validation Master Plans:The start point for a complete life cycle approach following proven and efficient validation practice such as GAMP5 and a risk based approach to validation.
  • Risk Assessments: Practical risk assessments and workshops to determine critical risk controls to be built into the validation program and to show you how to mitigate risk using hands-on exercises based on your real life examples.
  • Compliance  Training & Workshop: We deliver high quality training in all areas of GMP. Our course leaders are highly experienced in their respective fields and we offer standard and bespoke training schedules, tailored to each individual needs.
  • Supplier Audits: Factorytalk's experts conduct audits on your behalf to ensure that your suppliers worldwide are producing materials in accordance with the rules of good manufacturing practice (GMP)

 

IMPLEMENTATION SUPPORT:

  • Project Management: We provide experienced project managers across activities from facility, equipment's and systems to the successful conclusion of the assignment.
  • Validation Services: We offer full validation services including process validation, analytical method validation, cleaning validation, computer validation, equipment qualification. We provide best practice templates for design through to test documentation.
  • QMS Remediation: We review, design and implement / improve any Quality System, including for QA, Manufacturing, Laboratories, and support groups.
  • Enterprise Resource Planning Systems :We provide experts who lead you through all key phases including requirements definition, supplier selection and negotiation, validation and management of the project life cycle from URS to acceptance and handover. (For the purpose of this assignment no product license or product implementation services are proposed)

 

INSPECTION SUPPORT and OPTIMISATION SERVICES:

  • Pre inspection readiness and mock inspections: Our highly experienced experts conduct mock inspections to test your audit preparation and practice; we provide feedback to your management on the readiness of your organisation and facilities and prepare position statements and strategy for dealing with problem areas. We train your teams in inspection best practices.
  • Audit/Inspection support: We help to prepare / review key inspection documents (including presentations) and ensure any weak areas are well covered prior to the inspection date. We offer support on site with highly experienced support teams during the inspection to deal with immediate and follow-up responses and questions as required.
  • Post audit support :We manage any necessary improvements required e.g.. improving quality management systems and risk assessments that might arise from previous findings.
  • Overseas market development and sourcing:We offer targeted searches for suitable cooperative ventures, sales partners and acquisition candidates (M&A).
  • Productivity / process improvement:We help companies analyse and move to more efficient operations such as doubling output with the same number of staff and to complete lean assessments and surveys
  • Supplier Sourcing and Assessments:We ensure that your business investments and partnerships are aligned to the needs of your corporation and that provides realisable value and benefits at the required quality.
Compliance Services:

Technology Solutions: We provide up-front consulting, project management, design, implementation and support services for the leading products to the regulated industries to optimize compliance, quality and production processes.

Offshoring / Insourcing: Our goal is not just to achieve your success but to enhance and boost your baseline performance during the times of highest volumes and pressures.

News / Events
NEW REVISION OF PIC/S GMP GUIDE (PE 009-13) EFFECTIVE ON 1ST JANUARY, 2017

NEW REVISION OF PIC/S GMP GUIDE (PE 009-13) EFFECTIVE ON 1ST JANUARY, 2017 From 1st January, 2017, the new version of PIC/S GMP ...

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