Assessment FrameworkREF: AST-GUIDE-01

About This Assessment & Regulatory Scope

This self-check tool is an exploratory, application-led assessment designed to help laboratory, quality, and manufacturing teams across Ireland and the UK navigate suitable analytical options. It is an advisory tool, not an accredited certification.

What This Self-Check Provides

Exploratory guidance for technical scoping

Preliminary Process Scoping

Identifies whether PAT, NIR, Raman, or powder testing is conceptually suitable for your material stream.

Technology Alignment

Suggests relevant analytical hardware and sampling geometries based on basic laboratory parameters.

Feasibility Consultation Planning

Structures key technical questions prior to submitting real samples for formal bench testing.

Helps streamline your preparation before meeting with our application specialists.

What It Does Not Replace

Formal validation requirements for regulated labs

Not a Formal Regulatory Audit

Does not replace Annex 11, cGMP, or 21 CFR Part 11 validation protocols or compliance sign-offs.

Not a Certified IQ / OQ / PQ Protocol

Installation, operational, and performance qualifications must be executed on-site with certified reference standards.

Not a Guaranteed Analytical Assay

Spectral limits of detection and matrix interferences must be validated empirically in laboratory conditions.

Direct calibration and sample testing are essential prior to line integration.

Need Certified Qualification & On-Site Validation?

Our application engineering team provides formal feasibility studies, chemometric modeling, and compliant lifecycle validation services across Ireland and the UK.

Interactive Assessment Tool

Analytical System Matcher

Complete this four-step diagnostic to receive a tailored configuration summary for your laboratory or manufacturing process.

Step 01 of 04•Operating Industry
Operating Industry
Select the operational setting and regulatory framework of your facility.
Pharmaceutical Manufacturing

Finished dosage forms, OSD & sterile processing

Biopharmaceutical

Upstream cell culture, downstream purification

Chemical & Ingredients

Continuous synthesis, solvent recovery & bulk solids

Security & First Response

Field chemical identification & trace detection