Engineering, Project Collaboration, Document Control and Facilities Management Solutions for Life Sciences

Bringing Control to the Complex and Highly Regulated Life Sciences Industry

Solutions for:
  • CFR21 Part 11 Compliance
  • GMP Manufacturing
  • Healthcare Facility Management
  • SOP Distribution
  • Operations and Maintenance
  • Transmittals Management
  • Electronic Signatures
  • Faster System Validation
  • Engineering Drawing Management
  • Outsourced Document Control for Projects

 

Life Sciences companies face a wide variety of challenges, including growing regulatory requirements in both manufacturing operations and clinical trial processes and the importance of documenting  Good Manufacturing Practices (GMP). There is also the need for increased collaboration at different stages of the drug development lifecycle and pressures to shorten time to market.  

McLaren Software's industry leading engineering, project collaboration, document control and facilities management solutions are helping Life Sciences companies meet regulatory requirements, optimize manufacturing and healthcare facilities, and bring safe drugs, medical devices and healthcare to market on time and on budget.

McLaren Software's solutions:

  • Support the design, construction and operations and maintenance of major capital projects in the life sciences and healthcare sectors throughout the project lifecycle.
  • Ensure that all Life Sciences companies meet regulatory requirements, such as 21 CFR Part 11, through documentary evidence and transparent audit trails.
  • Support Life Sciences companies in complying with and providing evidence of GMP guidelines to regulators throughout the manufacturing process.
  • Help Life Sciences companies develop specific Standard Operating Procedures (SOPs) for document management and support the distribution of these throughout organizations.
  • Support healthcare providers in their healthcare facilities management activities
    covering all building design and building services activities.

McLaren Software is a proven, reliable solution with 300,000 users and 15,000 projects and asset operations in 50 countries.  McLaren offers the flexibility of cloud, on premise or privately hosted solutions to meet any business requirement. 

In addition to the application suite, McLaren offers consultancy, training and support services. With more than 20 years of industry and document control experience, McLaren Software's consultancy expertise will ensure that Life Science projects are delivered to the highest standards.