Validation Outsourcing: Getting the Most Out of Your Client–Contractor Relationship - - BioPharm International


Validation Outsourcing: Getting the Most Out of Your Client?Contractor Relationship

BioPharm International

Step 1. Be prepared for the contractor's arrival. Take appropriate measures to ensure the space provided to the contractor is conducive to project work. Ensure that computers are set up and have network connections and email, that access cards are available, and necessary supplies are on hand on the first day.

Step 2. Cultivate trust and commitment to the project by establishing a good, two-way communication channel between the project manager and the contractor.

Step 3. Conduct a tour of the work area and the plant. At the start of the project, be sensitive to contractor needs in their new work environment. In larger facilities, a single plant tour may be insufficient.

Step 4. Introduce the contractor to both the validation staff and the others who are involved in the project.

Step 5. Provide general training material to the contractor. Focus on providing training material on daily operations, such as the validation master plan, templates for protocols, and gowning procedures. We have all read standard operating procedures that left us confused or that are forgotten until we are actually using the procedure. It is important that clients focus on specific procedures that are used in later stages of the outsourcing project.

Step 6. Share your organizational charts. Project charts that show your company's hierarchy visually summarize staff roles; provide a guide for contractors when they need to determine appropriate communication channels; and inform contractors about key project players.

Project implementation. At this point, hours or days have been well spent crafting a solid, up-front foundation for the contractor. The objective of the project implementation phase is twofold: Delineate project needs, and provide further validation or project-specific training.

Step 1. Reiterate the proposal. Confirm that the contractor understands your expectations. Review equipment lists, deadlines, and milestones.

Step 2. Discuss the significance of the project: Is the validation a small-scale effort, or is it a corporate-wide goal? This determination influences other aspects of the project.

Step 3. Identify project dependencies; that is, inform the contractor of the people who directly affect the validation effort, typically through lateral relationships. Ensure that the contractor has met these people and knows how to contact them.

Step 4. Allocate time and staff to provide training. A contractor can review the material received and be trained "in the trenches" on specific procedures.

Step 5. To avoid delays, inform the contractor where equipment is stored and how to sign out equipment.

Step 6. Take a backseat. Let contractors do their jobs; that's what you pay them for.

Project maintenance. As a validation effort unfolds, there are victories and causalities, but the momentum of the project must continue at a quick pace. People need to stay motivated, positive, and excited about their work and validation. Project participants turn to their leader for support. Success tips for orchestrating project maintenance include

  • Take a backseat, but be a backseat driver. Keep aware of the progress and direction of the project.
  • Stay involved and communicate. Engaging in face-to-face discussions with a contractor can provide you with deeper insight into the details of the validation project.
  • Continue to foster the necessary lateral relationships (project dependencies). As the project unfolds, so do the relationships.
  • Energize staff by stating and restating the benefits of the contractor's effort. Focus on the benefit of the finished project.
  • Use mishaps and deviations as opportunities to reflect and learn.
  • Give recognition when deserved. Encouragement - a simple "good job" - can motivate the whole team.

Guiding Successful Projects This four-phase outsourcing strategy has several steps that can occur simultaneously, driven by the time scheduled for the project. But information from each step is important to your company and to the outcome of the project. By capturing the information from each step, you ensure that you know your contract and contractor and that you are aware of the project progress at each stage.

Experience teaches that successful validation efforts - those that maintain regulatory compliance - are achieved by orderly and timely commencement and continued project management. Staffing a validation department, however, can be difficult if qualified candidates are limited. Too few personnel or staff without the proper experience will affect the polished plan you want. As many companies have discovered, the capabilities of validation contractors can be used to supplement your current staff and facilitate successful validation projects. BPI

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