One of the most important choices a life sciences or healthcare organization makes during its ERP journey is choosing a NetSuite implementation partner. The system that the organization will use over the next ten years is shaped by the partner's configuration choices, design decisions, and domain knowledge—or lack thereof.
However, the majority of businesses spend more time assessing the ERP platform than the partner who will put it into use. It is necessary to reverse that ratio.
Why choosing a partner is a matter of compliance
A less-than-ideal implementation partner creates a system with reporting restrictions and efficiency gaps in unregulated industries. It can result in a system with compliance gaps in regulated industries, such as workflow controls that are present in the design but not in the configuration, audit trail flaws, and traceability issues.
These gaps are found by organizations at the worst possible time—during audits, investor diligence reviews, or IPO preparation. Correct configuration during implementation is far less expensive and disruptive than remediation in a live system with transaction history.
It is not a preference to select a partner with true industry depth. It is a risk management requirement for organizations that are subject to regulations.
The distinction between an industry-specific partner and a NetSuite partner
NetSuite implementation partners number in the hundreds. The majority are competent, certified, and will provide an operational ERP. Whether the partner has extensive, up-to-date experience in your particular regulatory environment is a crucial distinction for regulated organizations.
A partner with ten years of experience in retail and food and beverage implementations might have produced outstanding work in those areas. Specialty pharmacies, CDMO operations, and pharmaceutical manufacturing do not benefit from that experience. The frameworks for compliance differ. The operational processes are not the same. There is a difference in audit exposure.
FDA cGMP requirements, 21 CFR Part 11 compliance, DSCSA traceability requirements, HIPAA data handling, and SOX controls in regulated environments are just a few of the client-facing experiences that an industry-specific partner can offer. They have set up lot traceability for companies that have undergone that investigation, so they don't need to investigate what an FDA investigator looks for in a lot trace.
Things to consider during the assessment procedure
Five criteria should be used to evaluate a NetSuite implementation partner for regulated life sciences or healthcare work.
History of vertical implementation. In your particular subsector, how many implementations has the company finished? Ask for a list. The specific regulated industry experience of the team working on your project is more important than the firm's overall NetSuite experience.
Expertise at the consultant level. In particular, who will be in charge of your project? What is the history of each one's application in regulated settings? Your project shouldn't be managed remotely while junior resources handle the configuration; instead, senior consultants with regulated industry depth should be available.
Familiarity with compliance frameworks. In the implementation design, how does the partner handle SOX controls, cGMP requirements, and 21 CFR Part 11? A partner who truly understands compliance will provide a precise, thorough response. A generalist will explain how they generally approach compliance.
The ability to deliver validation. Implementation deliverables for regulated organizations go beyond configuration documentation. A comprehensive regulated implementation package includes audit trail configuration guides, IQ/OQ/PQ templates, and validation protocols. Does the partner have any examples from previous engagements?
Post-launch model. After go-live, how does the relationship between the partners look? Growing regulated organizations continue to require optimization work, managed services, and enhancement services. When changes are required, a partner without a post-go-live service model leaves the company without continuity.
Reference checks that demonstrate competence
In a regulated setting, a reference check for a NetSuite implementation partner should include more information than just whether the project was completed on schedule and within budget.
Specifically, find out: During the implementation design, how did the partner handle compliance requirements? Did the partner find any compliance gaps during the project, or did they find them after go-live? When the implementation scope was impacted by regulatory requirements, how did the partner react? If the client were to repeat the selection process, what would they do differently?
Speaking with a client who underwent an FDA audit, investor diligence review, or SOX audit following the partner's implementation is the most illuminating reference check. What you need to know is how the system fared under that scrutiny and how the partner helped the organization through it.
Structure of contracts and engagements
The engagement structure should outline the consultants assigned to the project, the minimum level of experience required for each role, how scope modifications and additions related to compliance are handled, what validation deliverables are part of the base scope, and what the post-go-live support model entails.
When the scope is clearly defined, fixed-fee implementations are typical and suitable. They are less suitable when the scope may be expanded by compliance requirements in ways that were not entirely anticipated at the beginning of the project. Before the project starts, the scope-change procedure should be agreed upon and documented.
Warning signs in the partner selection procedure
The inability to provide specific references in your vertical, a standard implementation methodology that ignores compliance requirements, validation deliverables that are not part of the base scope, a proposal that ignores data migration validation, and a team structure that does not specify which consultants will be on the project are all warning signs that a partner might not be the best fit for a regulated engagement.
Depending on which frameworks apply to your organization, a partner is not ready to implement for a regulated business if they are unable to explain how their implementation strategy handles 21 CFR Part 11, FDA audit trail requirements, or DSCSA traceability.