Solutions

Labtopia Solutions provides full consulting support to organizations wishing to seek or maintain ISO-based quality systems, NELAC accredited quality systems, GMP quality systems. Labtopia’s consulting services consist of partial or turn-key solutions for every aspect of the quality assurance system. We offer customized solutions based on the client’s scope of work. We provide:

  • Internal Audits
  • Supplier/Vendor Qualification Audits
  • Development of Corrective and Preventive Action Systems
  • Technical Writing
    • Manuals
    • Standard Operating Procedures
    • Work Instructions
  • Document Control
  • Training
  • Complaint Investigations
  • Corrective and Preventive Action Management
  • Interim and Part-Time Quality Assurance Support

Labtopia Solutions’ turn-key quality system implementation process is based upon years of experience and proven methodologies. We follow a standardized approach that has been recognized by the American Society for Quality (ASQ). For companies seeking accreditation or wishing to implement a quality system, we offer the following services:

  • Project Management
  • Gap Assessments
  • Process-Mapping
  • Technical Writing
  • Development of Quality Objectives and Metrics
  • ISO Training / GMP Training
  • Selection of Registrars
  • Assistance during certification audits or inspections

Our professionals have experience within various industries and are experts at deploying quality systems that must meet dual certification schemas or regulatory requirements. Labtopia Solutions’ consultants work with company representatives to establish systems that make sense for the business, while meeting the requirements of a standard or regulation. Labtopia Solutions supports the following industry standards and certifications:

  • ISO 9001
  • ISO 17025
  • ISO 13485
  • 21 CFR Part 210 & 21 CFR Part 211
  • 21 CFR Part 820
  • IPEC:PQG
  • SQF 2000
  • NELAC

In addition, Labtopia Solutions consultants are specialists in quality related database design, configuration and deployment. We have developed requirements, workflows and worked with programmers to create systems within Windows Sharepoint, Lotus Notes and Salesforce® to manage nonconformances, CAPAs, and complaints. In addition, Labtopia Solutions can assist with development of requirements documents for solicitation and purchase of commercial quality enterprise management systems and provide project management for implementation of EDMS and EQMS.