Computer System Validation · Custom GxP Software
Validation thatsurvives the audit.
PharmaEddge is a validation and software consultancy for pharma and biotech. We qualify your systems to GAMP 5 and 21 CFR Part 11, and build the GxP software your quality team actually needs — remote or on-site, anywhere.
Table 1.1 — Record of performance
Computer System Validation
Execution Checklist
- User Requirement SpecificationPASS
- Risk Assessment · FMEAPASS
- IQ / OQ / PQ ProtocolsPASS
- Traceability MatrixPASS
- Validation Summary ReportPASS
Effective: 2026 · Status: RELEASED
- GAMP 5
- Risk-based validation of computerized systems
- 21 CFR PART 11
- FDA electronic records & signatures
- EU ANNEX 11
- EU GMP for computerized systems
- ALCOA+
- Data integrity principles
- PIC/S
- Harmonized GMP inspection guidance
- CSA
- FDA computer software assurance
DOC PE-WEB-001 · SEC 2.0
Validation & Compliance · PAGE 2 OF 9
Validation & compliance services
Every engagement is scoped risk-based: enough rigor to defend in front of any inspector, none of the over-validation that burns your budget.
Standalone, server-based, PLC, HMI and DCS systems validated end-to-end with a risk-based GAMP 5 approach — from planning through release.
Full lifecycle validation of enterprise systems — ERP, LIMS, MES and lab software — including supplier assessment and configuration verification.
Protocol authoring and on-floor execution of installation, operational and performance qualification, with deviation handling and traceability.
System categorization and functional risk assessment using GAMP 5 categories and FMEA, so validation effort lands where the risk actually is.
Audit-trail review, access-control evaluation and ALCOA+ gap assessment across paper and electronic records — with a pragmatic remediation plan.
Site-wide 21 CFR Part 11 and EU Annex 11 gap assessments, remediation roadmaps, and SOP authoring your teams will actually follow.
Documentation review, mock audits and inspection-readiness coaching so an FDA or EMA visit is a walkthrough, not a scramble.
DOC PE-WEB-001 · SEC 3.0
GxP Software · PAGE 3 OF 9
Software built validation-ready.
Most vendors build software, then bolt compliance on. We build the other way around: audit trails, Part 11 e-signatures, and access controls are in the architecture from the first line of code — and the validation package ships with the product.
SYS-01 · EDMS
Electronic Document Management
Controlled documents, versioning, review workflows and e-signatures.
AUDIT TRAIL ✓ E-SIGN ✓ PART 11 ✓
SYS-02 · EQMS
Electronic Quality Management
Deviations, CAPA, change control and complaints in one audit trail.
AUDIT TRAIL ✓ E-SIGN ✓ PART 11 ✓
SYS-03 · LMS
Training Management
Role-based curricula, assessments and training records that hold up in audits.
AUDIT TRAIL ✓ E-SIGN ✓ PART 11 ✓
SYS-04 · LIMS
Laboratory Information Management
Samples, specs, stability and results — with full data lineage.
AUDIT TRAIL ✓ E-SIGN ✓ PART 11 ✓
SYS-05 · HR-01
Attendance & Payroll
GxP-site attendance and payroll, integrated with your access records.
AUDIT TRAIL ✓ E-SIGN ✓ PART 11 ✓
Need something that doesn't exist yet?
Scope a custom buildDOC PE-WEB-001 · SEC 4.0
Method of Execution · PAGE 4 OF 9
How an engagement runs
Five phases, each with a defined deliverable. You always know where the project stands — the same discipline we apply to your systems, applied to ourselves.
PH-01 · VERIFIED
Assess
System inventory, GxP impact assessment and gap analysis. We establish what you have, what regulation touches it, and where it stands.
PH-02 · VERIFIED
Plan
Validation Master Plan and risk-based scope. GAMP 5 categorization and FMEA decide how much rigor each system actually needs.
PH-03 · VERIFIED
Execute
IQ, OQ and PQ protocols authored and executed — deviations investigated and closed, not buried.
PH-04 · VERIFIED
Document
Traceability matrix and validation summary report. Every requirement maps to a test; every test to evidence.
PH-05 · VERIFIED
Sustain
Periodic review, change control support and revalidation triggers, so the validated state survives the next upgrade.
DOC PE-WEB-001 · SEC 5.0
Acceptance Criteria · PAGE 5 OF 9
Acceptance criteria for a validation partner
Hold us to the same standard we hold your systems to. Six criteria, all verified.
Deep domain tenure
AC-1 · PASS25+ years of combined validation experience across pharma, biotech and medical devices — we have seen your system before.
Remote or on-site
AC-2 · PASSFull engagements delivered remotely, on your site, or hybrid — the documentation quality is identical either way.
Right-sized rigor
AC-3 · PASSRisk-based scoping means no over-validation. Category 3 systems get Category 3 effort, not a Category 5 invoice.
Audit-ready documentation
AC-4 · PASSEvery deliverable is written to be read by an inspector, not just filed. Traceable, legible, defensible.
Transparent pricing
AC-5 · PASSFixed-scope packages with deliverables named up front. No day-rate meters running quietly in the background.
Global regulatory coverage
AC-6 · PASSFDA, EMA, CDSCO, PIC/S — one validation package structured to satisfy all the agencies you answer to.
DOC PE-WEB-001 · SEC 6.0
Company Master File · PAGE 6 OF 9
Where compliance meets clarity.
PharmaEddge is a team of validation engineers and software builders who have spent their careers inside regulated manufacturing — writing the protocols, executing the qualifications, and sitting across the table from inspectors.
That experience shaped a simple conviction: compliance documentation should make systems easier to understand, not harder. A good validation package is not a stack of paper — it is the clearest description of how your system works that will ever be written.
We work with pharmaceutical manufacturers, biotech firms, medical device companies and CDMOs, from single-instrument qualifications to site-wide remediation programs.
Company Master File
- Entity
- PharmaEddge Consulting
- Discipline
- CSV · GxP Software
- Delivery
- Remote / On-site
- Coverage
- Worldwide
- Frameworks
- GAMP 5 · Part 11 · Annex 11
- Status
- Accepting engagements
Reviewed & current · 2026
DOC PE-WEB-001 · SEC 7.0
Clarifications · PAGE 7 OF 9
Questions we hear in every kickoff
A single standalone instrument typically runs 2–4 weeks end-to-end; an enterprise system like LIMS or ERP runs 2–4 months depending on configuration depth. The Assess phase gives you a firm timeline before you commit to anything.
Yes — legacy remediation is a large share of our work. GxP-critical spreadsheets can be validated (or replaced with something better), and legacy systems can usually be brought to a defensible state without ripping them out.
Yes. Document authoring, reviews, risk assessments and most software validation run remotely. Activities that need hands on equipment — IQ walks, instrument OQ — we do on-site or guide your team through live.
It is built to be: audit trails, unique user credentials, e-signature manifestation and record protection are core architecture, and every product ships with its own validation package so your part of the compliance burden is already documented.
Both, appropriately. Our method is GAMP 5 risk-based at its core, which is exactly the direction FDA's Computer Software Assurance guidance points: critical thinking and testing where risk lives, less ceremony where it doesn't.
DOC PE-WEB-001 · SEC 8.0
Initiate Engagement · PAGE 8 OF 9
Initiate an engagement
Tell us what system keeps you up before an audit. First consultation is free, and scoped like everything else we do: you leave with a concrete assessment, not a sales pitch.
Direct line
pharmaeddge@gmail.comAttributable. Legible. Contemporaneous. Original. Accurate. — we practice what we validate. Your details are used to reply to you and for nothing else.