When electing to outsource commissioning, qualification and/ or validation, a key consideration is which type of external partner to engage. Companies commonly have four options – partnering with a recruitment firm, hiring individual contractors, utilising an integrated project delivery firm, or working with a dedicated validation service provider. Each model has unique pros and cons relating to costs, risks, capabilities, and experience. This article will examine the core benefits and potential pitfalls of outsourcing validation to the different types of external organisations. Key questions to ask when evaluating partners will also be explored to help guide decisions appropriate to a company’s specific needs and priorities.
Using a Recruitment Firm
Potential Benefits:
- Time savings- Recruitment firms expedite the sourcing of qualified contract staff, leveraging candidate searching software and a pool of existing candidates for efficient ad-hoc role filling.
- Scalability and flexibility to meet changing demands- Recruitment firms can quickly search for more people matching your requirements due to an existing pool of candidates.
- Recruitment firms with specialised recruitment consultants recruiting for quality assurance and validation roles can provide benefits over in-house recruitment as recruiters become attuned to the skills required for a specific role type.
Potential Risks:
- Recruitment firms lacking in-house on-the-job expertise may pose a risk of hiring lower-quality contractors. To address this, assessing the credentials and on-the-job experience of the hiring team is advisable.
- Lack of end-to-end validation resources, capabilities and equipment beyond contractor hiring.
Engaging Individual Contractors
Potential Benefits:
- Cost savings: Engaging individual contractors can result in cost savings by avoiding overhead costs compared to other methods.
- Culture fit: Companies handling the engagement of contractors themselves may have a deeper insight into the company culture, aiding in the identification of candidates who are a good cultural fit.
- Companies with their in-house recruitment process can build up their own list of qualified candidates that they can keep on file for other job vacancies.
- Potentially more control over the recruitment process compared to other methods.
Potential Risks
- Insufficient internal expertise may lead to the placement of low-quality contractors.
- If there is no internal recruitment department, time losses due to the increased workload of the hiring process can occur.
- UK companies hiring contractors are responsible for determining if the contractor should be inside or outside IR35. This additional administrative burden can make hiring contractors less attractive for some companies. Some companies may be particularly deterred from hiring contractors due to the complexities of assessing IR35 status. This could potentially limit the diversity of contractors they hire.
Partnering with a Project Delivery Firm
Potential Benefits:
- Validation bundled with construction/ fit-out services means there are fewer potential vendors to deal with, streamlining the process for large projects.
- Time benefits- Project delivery firms can save time in the hiring process for qualified contract staff, providing efficiency benefits.
- Material, time, and cost wastage can be minimised due to the collaborative approach of the project delivery firm. Project resources are acquired on an as-needed basis.
- Consultants from project delivery firms have expertise in a wide range of industries, including pharmaceuticals, allowing for innovative problem-solving approaches.
- If you are a UK company, you have to worry about IR35 if using the project delivery firm’s internal staff.
Potential Risks:
- Minor deviations from key requirements during the validation process can sometimes be overlooked, especially if the EPC contract has already been signed with the contractor to fulfil the full scope of work without specifying the details of the validation process. This approach may lead to unintended time and cost risks filtering back to the client.
- Costs associated with project delivery firms may be higher due to profit margins, and companies should weigh these against the benefits.
Partnering with a Specialized Validation Service Provider
Potential Benefits:
- Time benefits- Specialised providers can save time sourcing qualified contract staff as they already have a pool of internal staff for projects.
- Deep expertise: Profound knowledge in validation within specialised providers can lead to the placement of knowledgeable personnel, with a thorough expertise assessment during initial interviews.
- Focus on knowledge transfer: It is often important to ensure that the knowledge of external experts is coherently transferred to internal staff so that knowledge becomes increasingly in-house over time. Some validation service providers, such as BPV, have working practices to ensure that this knowledge transfer is part of the service package through providing structured handovers, personalised articles and training if needed.
- End-to-end capabilities covering the full validation lifecycle can mean these providers can get to know your equipment and support you in future should you need it, which can reduce the number of vendors.
- Innovation and Resources: Specialised providers often have a keen awareness of validation-specific technological and regulatory updates that they can share with their clients.
- UK companies won’t have to worry about IR35 if you choose to use the validation service provider’s internal staff. This can be a great option for ensuring compliance with IR35 regulations while also benefiting from the expertise of the provider’s knowledgeable staff.
Potential Risks:
- Higher costs associated with specialised providers should be evaluated through a thorough cost-benefit analysis over an extended period.
- Specialist and not generalists: Some specialised validation service providers may have limitations on the services they can provide and may only be experts in certain types of validation, such as process validation, but not in cleaning validation or sterile environment validation. Companies need to evaluate their specific validation needs and ensure that the chosen provider has the necessary expertise to meet those needs.
Conclusion
While cost will always be a factor, it is important not to let it be the sole decision driver. Taking the time to thoroughly assess internal capabilities and needs, along with evaluating the expertise and experience of potential partners, will lead to the best long-term outcome. Conducting due diligence and cost-benefit analysis of the various options will provide the insights needed to make the right strategic choice for successful validation delivery.
See below for a checklist of questions to ask yourself as part of your cost-benefit analysis:
- What is the internal capability of my company to carry out validation with confidence?
- Do I or my company know what good looks like?
- How certain am I that my company is following the most up-to-date and compliant protocols?
- What would be the impact of hiring someone who didn’t have an up-to-date knowledge of validation or efficient working practices?
- How much time do I or the hiring manager have to source a quality candidate alongside other responsibilities?
- How specialised is the firm I am looking at for validating the specific piece of equipment?
- How much experience do the validation engineers who are employed by the firm have?
- What is the experience level of the validation engineers employed by the firm?
Bio Products Validation is a specialised provider of validation services to the UK and Ireland Life Science industries. Should you need assistance in determining if working with a validation service provider is right for your business please reach out to our friendly team using the contact form here.
