Pharma Software Development: What an Offshore Web Team Can and Can't Do

An offshore web team can build a pharma company's marketing sites, HCP portals, event and speaker-program tools, internal dashboards and non-GxP workflow apps, for teams in the US, Europe or elsewhere. It should not build GxP systems, eQMS, LIMS, EDC or 21 CFR Part 11 e-records; those need a validated vendor with a QMS. RAITHub offers the first list, has no pharma clients, and builds nothing on the second.

This guide draws that line clearly, explains the rules that put a system on one side or the other, and shows how to scope offshore web work so it never touches patient data. It is engineering guidance, not a record of shipped pharma work: RAITHub has not built software for a pharmaceutical company, and it says so up front.

What does "GxP" mean, and why does it decide who can build your software?

GxP is shorthand for the "good practice" quality rules in life sciences: good manufacturing practice (GMP), good clinical practice (GCP), good laboratory practice (GLP) and their relatives. A system is GxP-relevant when it creates, changes or stores records that a regulator relies on to judge product quality or patient safety.

Once a system is GxP-relevant, the regulated company must be able to show it was validated: specified, built, tested and controlled under a documented quality process. That duty reaches the software supplier. The EU GMP guide's Annex 11 on computerised systems says the regulated user should take all reasonable steps to ensure a system "has been developed in accordance with an appropriate quality management system", and that the supplier "should be assessed appropriately". It also expects quality-system and audit information about software suppliers to be available to inspectors on request.

A quality management system (QMS) is the documented set of procedures, training records, change control and audit history that lets a vendor prove how its software was made. A general web studio does not run one to pharma standards. RAITHub does not. That single fact decides most of this page.

What do pharma companies commonly outsource to web development teams?

Customer-facing web properties and internal tools whose records are not GxP records. These are ordinary software projects with pharma-specific review steps around the content, not around the code.

• Marketing and corporate sites. Product, disease-awareness and corporate sites. The engineering is standard; what differs is that every page goes through the company's medical, legal and regulatory review (often called MLR review) before it is published.
• HCP portals. Sites for healthcare professionals (HCPs) with registration, professional verification, gated content, consent and preferences. Promotional-content rules differ by market, so the rules engine has to be configurable.
• Event and speaker-program tools. Registration, attendance, speaker contracts and logistics for medical education events. In the US, payments and transfers of value to physicians are reported through the CMS Open Payments programme, so these tools often need a clean export for the team that files those reports.
• Internal dashboards. Sales, marketing, field-force and operations reporting over data that is not a GxP record.
• Non-GxP workflow apps. Content request intake, contract and budget approvals, vendor onboarding, travel and meeting requests: the internal paperwork that is currently a spreadsheet and an email chain.

Which pharma systems need a validated vendor with a quality system?

Anything that creates or holds GxP records, and anything that produces electronic records or signatures that a regulator treats as equivalent to paper. In practice that means these categories, and RAITHub builds none of them:

• GxP systems in general: manufacturing execution, batch records and release, and anything else inside the GMP boundary.
• eQMS (electronic quality management systems): deviations, CAPA (corrective and preventive action), change control, document control and training records.
• LIMS (laboratory information management systems): samples, test results and the chain of custody behind them.
• EDC (electronic data capture) for clinical trials: the systems that record trial data from sites.
• Part 11 e-records and e-signatures: any system where an electronic signature stands in for a handwritten one on a regulated record.

The US rule is 21 CFR Part 11, as explained in FDA guidance. FDA reads its scope narrowly: it applies to records required by the underlying "predicate rules" that are kept in electronic form in place of paper, or relied on electronically for regulated activities, and to electronic signatures meant to be equivalent to handwritten ones. The controls themselves are listed in 21 CFR 11.10, starting with "validation of systems to ensure accuracy, reliability, consistent intended performance, and the ability to discern invalid or altered records", and including secure, computer-generated, time-stamped audit trails.

In Europe the equivalent reference for manufacturing is Annex 11. Its principle is short: "The application should be validated; IT infrastructure should be qualified." It then covers risk management, suppliers, validation, audit trails, security and electronic signatures, which must be permanently linked to their record and include the time and date they were applied. The industry's practical method for all of this is ISPE's GAMP 5 guide (second edition, July 2022), a risk-based approach to GxP computerised systems that encourages regulated companies to make full use of supplier knowledge and documentation. That only works if the supplier has documentation worth using.

General information, not regulatory advice. Whether a particular system is GxP-relevant, and what validation it needs, is a decision for your quality assurance (QA) and regulatory teams. Confirm with your adviser and read the current text from FDA or the European Commission's EudraLex Volume 4.

So what can an offshore web team build for pharma, and what can't it?

Use this table as a first sort, then have your QA team confirm the grey rows.

System	Offshore web team (such as RAITHub)?	Why
Marketing, disease-awareness and corporate sites	Yes	Standard web engineering; your MLR team approves the content
HCP portal: registration, verification, gated content, consent	Yes	Not a GxP record; market rules on promotional content set the gating logic
Event and speaker-program tools	Yes	Operational data; spend exports go to your transparency-reporting team
Internal dashboards over sales, marketing or ops data	Yes	No GxP records in scope
Non-GxP workflow apps (content requests, approvals, onboarding)	Yes	Business process only; your QA team confirms they sit outside the GxP boundary
A dashboard that reads data out of a validated system	Ask QA first	Read-only access may be fine, or may pull the tool into scope
A web form that receives adverse-event or product-complaint reports	Ask QA first	The form can be web work, but reports must flow into your safety or quality system without loss or delay
eQMS: deviations, CAPA, change control, training records	No	GxP records; needs a validated vendor with a QMS
LIMS	No	Laboratory GxP records and data integrity controls
EDC and other clinical-trial data systems	No	Trial data under GCP, typically with Part 11 controls
Anything with Part 11 or Annex 11 electronic signatures	No	Signatures on regulated records need validated systems

The "Ask QA first" rows are where offshore projects go wrong. The honest default is to design the web tool so it hands data to the validated system through a narrow, documented interface and keeps nothing of regulatory weight itself.

How do you scope an offshore pharma web project safely?

Keep patient data out entirely, test on synthetic data, and write the GxP boundary into the contract.

Scoping rule	What it looks like in practice
No patient data, ever	The offshore team has no access to patient records, trial data or safety reports, in production or in copies
Synthetic data for every environment below production	Generated test HCPs and events, clearly marked, with undeliverable email addresses
A written GxP boundary	The statement of work lists the systems in scope and states that none is GxP-relevant, signed off by your QA team
Narrow interfaces to validated systems	Where data must cross into a validated system, one documented API or file drop, owned and tested by that system's vendor
Your access controls, your identity provider	Staff sign in through your single sign-on; the vendor follows your security controls and signs your DPA and SCCs where personal data is involved
Named owners	One person on your side owns regulatory decisions; one owns MLR sign-off for content

Synthetic data should be obviously fake, so it can never be mistaken for, or mixed with, real records. A minimal seed script for a development or staging database:

// seed/synthetic-hcps.ts: development and staging only
type SyntheticHcp = {
  id: string
  name: string
  email: string
  specialty: string
  synthetic: true
}

const SPECIALTIES = ['cardiology', 'oncology', 'dermatology', 'general practice']

export function syntheticHcps(count: number): SyntheticHcp[] {
  if (process.env.APP_ENV === 'production') {
    throw new Error('Synthetic seed must never run against production')
  }
  return Array.from({ length: count }, (_, i) => ({
    id: 'syn-hcp-' + String(i + 1).padStart(4, '0'),
    name: 'Test Clinician ' + (i + 1),
    email: 'hcp' + (i + 1) + '@example.test', // reserved TLD, never deliverable
    specialty: SPECIALTIES[i % SPECIALTIES.length],
    synthetic: true,
  }))
}

The .test top-level domain is reserved for testing by RFC 2606, so a seeded email can never reach a real clinician. The synthetic: true flag lets reports and exports filter test rows out, and the environment check stops the script from running where it should not.

What does an offshore team need from your side to do this well?

Three things that only you can provide: approved content, a clear GxP boundary and fast answers on market rules.

• Approved content and a review calendar. MLR review often sets the release date, not the code. Build the review steps into the schedule.
• Market rules in writing. Which content is promotional in which country, who may see it, and what verification you require. Your regulatory team decides; the developer implements.
• Access to the systems at the edges. Your CRM, identity provider and any validated system the web tool hands data to, through test environments.

Time zones matter less than people expect for this kind of work, because most of it is review-driven. RAITHub works from Dhaka (UTC+6). For US clients it offers a daily 2-hour evening overlap (Dhaka 19:00–21:00, which is 08:00–10:00 in New York in winter). Against a 9:00–18:00 day at both ends, the UK overlap is 3 hours in winter and 4 in summer, and Central Europe is 4 hours in winter and 5 in summer. Everything else runs async with written daily handoffs, and the working week is agreed per client.

Why RAITHub for this

For the web side of pharma only, and for a team that already has QA and regulatory people who will draw the GxP line. RAITHub is a founder-led software studio, founded in 2024 in Dhaka, Bangladesh, working with clients worldwide in English.

• Role-heavy portals, proven elsewhere. Sundor Skin, a B2B wholesale platform, runs on 146 PostgreSQL tables with row-level security, 88 permission codes and 12 staff roles, backed by 530+ automated tests. HCP portals are role and permission problems of the same shape. See the work page.
• Several portals on one platform. TheSkinProof, the founder's own venture rather than a client project, has 5 portals, 217 API endpoints and 750+ tests.
• Health-adjacent, not regulated. RAITHub has built a healthcare scheduling app for a client. It has not shipped a regulated health product, and it has no pharma clients. The health software guide sets out the same position for health products.
• Test-gated releases. Every release runs the automated suite first, which suits content-heavy sites where one broken gate could expose promotional material to the wrong audience. The method is in how RAITHub tests.
• Clear commercial terms. A fixed-scope build or a dedicated monthly team, a written quote after a free 15-minute technical audit, an NDA before detailed discussion, and you own the IP. The models are on the pricing page.

When you don't need us

If the system is on the "No" side of the table, you need a vendor that runs a QMS, supports your validation and can face an audit. RAITHub cannot, and will say so on the first call.

• You need an eQMS, LIMS or EDC. Buy an established validated product and configure it, or hire a specialist life-sciences vendor to extend it.
• You need Part 11 or Annex 11 electronic signatures. That is validated-system work.
• Your procurement requires a certified vendor. RAITHub holds no SOC 2 or ISO 27001 certification and no pharma quality certification.
• The project needs patient data to work. RAITHub's scope for pharma excludes it.
• You want developers placed inside your team under your management. RAITHub offers fixed-scope builds and dedicated teams, not staff augmentation.
• A configured platform will do. Many HCP event and content needs are met by your existing CRM or marketing platform. Custom code makes sense only when that platform cannot handle your market rules or workflows.

How do you start a pharma web project with RAITHub?

Bring a short list of the systems you want built, the markets they serve and the name of the person who owns the GxP boundary. The SaaS and web platform development page describes how RAITHub builds portals and internal tools, and the HealthTech page covers the wider health context. Then book the free 15-minute technical audit. Do not send patient data, trial data or unapproved promotional material in the first message.

You will get a written memo that sorts your list into what RAITHub can build, what needs a validated vendor, and what your QA team should decide first.

Frequently asked questions

Can an offshore team build pharma software?

Yes, for web work outside the GxP boundary: marketing sites, HCP portals, event and speaker-program tools, internal dashboards and non-GxP workflow apps. GxP systems such as eQMS, LIMS and EDC, and anything with Part 11 electronic signatures, need a validated vendor with a quality management system.

Does RAITHub build 21 CFR Part 11 or GxP-validated systems?

No. RAITHub builds no GxP-validated or Part 11 systems, has no pharma clients and has shipped no regulated health product. It builds web portals and internal tools that stay outside the GxP boundary your QA team defines.

What is 21 CFR Part 11?

It is the FDA regulation on electronic records and electronic signatures. It applies to records that FDA predicate rules require, when they are kept electronically in place of paper, and to electronic signatures meant to be equivalent to handwritten ones. Its controls include system validation and secure, time-stamped audit trails.

What is GAMP 5?

GAMP 5 is ISPE's guide to a risk-based approach for GxP computerised systems. The second edition was published in July 2022 and covers modern practices such as iterative development, cloud computing and AI.

Is an HCP portal a GxP system?

Usually not, because registration, verification and content gating do not create GxP records. It becomes a harder question if the portal receives adverse-event reports or feeds a validated system, so ask your QA team to confirm the boundary for your portal.

How do you keep patient data away from an offshore team?

Scope it out in the statement of work, give the team no access to patient, trial or safety data in any environment, and use clearly marked synthetic data for development and testing. Where data must reach a validated system, route it through one documented interface owned by that system's vendor.