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CSols, Inc.

Deployment and Validation of a Global Manufacturing LIMS

CSols staff performed multiple roles over a two- year period assisting the pharmaceutical company with the implementation and validation of a global LIMS. Critical roles performed by several members of CSols staff included:

  • Global LIMS Project Consultant
  • Consulting for Prototype Assessment
  • Making Recommendations for resolving Design Challenges
  • Assessment of Global Stability Requirements
  • Site Deployment Planning
  • Management of the US Validation Team
  • Development of the Master Validation Plan
  • Development of Risk Analysis and Assessment Plan
  • Liaison between the pharmaceutical company and the LIMS Vendor
  • Participation as a Validation Consultant
  • Regional Site Deployment Management in Europe

The client’s objectives included the following:

  • Implement a multi-lingual, global LIMS solution which would standardize processes throughout sites in the UK, Ireland, Italy and Spain;
  • The solution must be 21CFR Part 11 compliant. The validation will be based on the GAMP 4 model;
  • The LIMS system must improve interfaces, such as the SAP and Chromatography interfaces.
  • The solution will facilitate Controlled Worksheets, provide multi-language Certificates of Analyses, and produce Annual Product Reviews.

In order to achieve these objectives the clients faced the following challenges:

  • Lack of business and technical resources to manage and execute the validation process;
  • Aggressive timelines;
  • Much of the infrastructure for the system would be located, remotely, in the United Kingdom, and various sites throughout Europe.

CSols’ Role & Expertise:

The CSols team managed the project, starting with the initial project organizational meetings with the stakeholders, throughout the gathering of User Requirements, creation of Validation Plan and its execution. The CSols Project Manager traveled globally, and participated in all key meetings at all Regional LIMS Meetings, training workshops, and discussions with the pharmaceutical client.

The CSols Project Manager participated in evaluation of the EU LIMS prototypes at the US Headquarters, in the prototype workshops at the client’s European sites, and in solving the site design challenges.

The CSols team brought organization and action to the project. Acting as a liaison between the client and the software manufacturer, CSols was able to quickly identify configuration, customization, and process issues and bring about a timely resolution, keeping the project progressing, with deliverables as close to timelines as possible. The expertise in script authoring provided a standard to which future scripts would adhere; thus, giving a highly desirable uniformity and consistency to the validation documents.

CSols was intimately involved with all discovered bugs and their resolution within the customized software during the implementation and testing of the system. CSols used our product expertise and communication skills to provide the needed link between Thermo Electron and the client.

In conjunction with other project personnel, CSols developed site deployment plans which addressed all the site specific activities needed to move the developed LIMS into production on schedule. These plans addressed areas such as:

  • Static Data Loading
  • Data Migration
  • Training
  • Validation
  • SOPs
  • Staffing levels

CSols performed the role of the Site Deployment Manager. As such, we were responsible for working with the regional leads to ensure accurate completion of the site deployment plans.

CSols Validation Consultants used their product knowledge to successfully execute many of the OQ scripts and to perform a “dry” run of many PQ scripts, ensuring the smooth execution of those scripts once delivered to the client.

Project Description:

Perform workflow analysis and optimization services for the client as a precursor to the implementation of a LIMS system.

The process involved the following steps:

  • Interviewed 35 key stakeholders from the representative groups (labs and customers).
  • Performed as-is and to-be workflow analysis workshops for all five QO (Quality Operations) laboratories (a total of 11 four-hour workshops) and documented the findings in two reports. During the workshops, CSols recommended solutions for improving overall laboratory efficiency and effectiveness.
  • Performed an assessment of all existing software solutions used by the laboratories and recommended which ones should be eliminated and/or changed as a result of a LIMS implementation.
  • Developed a LIMS implementation strategy document for the Toronto site which would maximize the probability of success based on CSols experience.
  • Developed a LIMS User Requirements Specification for the client to be used for evaluating potential LIMS vendors.

Client Objectives:

Client’s objectives were to partner with an experienced LIMS vendor to provide:

  • An understanding of LIMS and how the laboratory workflows and processes would change as the result of a LIMS implementation.
  • A LIMS implementation strategy for the Toronto site which would maximize the probability of a successful LIMS implementation. The site has had three unsuccessful LIMS implementation attempts in the past.

Client Challenges & Problems:

  • As stated above, the Toronto site has had three unsuccessful LIMS implementation attempts in the past. As a result, the word “LIMS” has a culturally negative stigma at Monsanto.
  • As a result of not having a LIMS, the laboratory processes are all paper-based and the laboratories create and manage a large amount of paperwork on a daily basis.
  • Since they have no LIMS experience, the Toronto site is at a disadvantage when discussing and negotiating LIMS-related issues with their United States and France colleagues.
  • Also, as a result of not having a LIMS, they were not quite sure which standalone systems would need to be retired and which ones would need to be retained.

CSols Role & Expertise:

The two CSols associates assigned to the project brought well over 30 years of combined experience with LIMS programming and system management and working in GxP regulated environments to the table.

CSols role was twofold:

  • Subject Matter Experts: Act as LIMS subject matter experts while leading the to-be workflow workshops, and drafting the LIMS Implementation Strategy document and the User Requirements Specification document.
  • Business Analysts: Analyze the client’s laboratory processes from all business perspectives (e.g. procurement, internal costing, compliance, manufacturing, stability, records, information technology, batch release, biostatistics, etc…). Communicate potential LIMS implementation issues to the client. For example, CSols determined that the client would have to modify their process of labor costing if they wish to implement the industry standard SAP interface.

How was CSols able to help?

Because of CSols’ LIMS implementation, instrument interfacing, and systems integration experience, CSols gave the client a much needed “roadmap” or “vision” into the future; that is, what it would be like working in an automated laboratory.