21 CFR Part 11
Electronic records & signatures
Signing re-enters the password (and authenticator code when enabled), records the meaning and reason, and binds a hash of the record.
RENOVA-RDX · Pharma R&D and Regulatory
Every product, from first trial to registration, on one record.
RENOVA-RDX is pharmaceutical R&D software that keeps data collection, formulation, analytical methods, stability, QA and regulatory affairs on the product they belong to, so the dossier is built from the same records the lab produced and a registered product stays locked until a variation is approved.
- Stage 1Data collection
- Stage 2Materials
- Stage 3Lab trials
- Stage 4Pilot scale
- Stage 5Approved formula
- Stage 6Method validation
- Stage 7Authority file
- Stage 8Stability
- Stage 9Registered
Each stage is decided from real records, such as three passing pilot batches or an approved validation. Registration locks the approved composition and methods.
- 9
- Lifecycle stagesData collection to registered
- 10
- Product tabsEvery record opens inside the product
- 5
- Stability study typesAccelerated to preservative efficacy
- 5
- CTD modulesSeeded on every dossier
End to End
From the First Monograph to the Last Variation
Each department works on the same product record, so a formula, a method or a stability result entered once is the one the regulatory team cites.
- Collect referencesData Collection
- Order materialsPurchasing
- Run trialsFormulation
- Develop & validateAnalysis
- Put on stabilityStability
- Approve & releaseQA
- Compile dossierRegistration
- Record approvalsApprovals
- Change by variationVariation
The Modules
Eight Modules, Shown in the Real Application
Pick a module to see its screen. Every screenshot is taken from RENOVA-RDX running on demo data.
01 / 08
Data Collection
A product cannot start formulation until its references are in.
- Product documents: references, monographs and papers
- Reference product with originator, label link and patent expiry
- Readiness check: an accepted pharmacopoeia monograph and formulation reference
- AI research that suggests sources for the team to accept
02 / 08
Formulation
Numbered trials, scale-up and approved formula versions in one place.
- Formulation requests and numbered lab-scale trials with trial history
- Versioned formulation templates and master checklists copied onto each trial
- Pilot and production scale-up; three passing pilot batches before approval
- Formula versions that must total 100% w/w, excipient compatibility, tech transfer
03 / 08
Analysis
Methods developed, validated and handed to QC on the same product.
- Analysis requests and method trials: column, mobile phase, wavelength, dissolution
- ICH Q2(R2) method validation with acceptance criteria and pass/fail per parameter
- Specifications that stability OOS and OOT are evaluated against
- Method of analysis as a numbered document, method transfer to QC
04 / 08
Stability
Studies, pull points and results checked against the specification.
- Accelerated, long-term, in-use, on-going and preservative efficacy studies
- Monthly plan and pull schedule per study and batch
- Time-point results flagged out of specification or out of trend
- Shelf-life estimate from long-term data; a failure raises a formulation request
05 / 08
QA
The approved product definition, and what happens to it on the market.
- Composition, finished product specification and method of analysis
- Leaflet, primary and secondary packaging, manufacturing process
- Process validation and product release decisions
- Complaints, recalls and a per-product audit trail
06 / 08
Registration
Every submission and approval for every market, on the product.
- Dossiers per country and authority with a CTD Module 1–5 checklist
- Submission sequences with dates and authority references
- Naming, pharmacovigilance, scientific, soft and hard file submissions
- Importing plans, bioequivalence studies, approvals and licences
07 / 08
Variation
After registration, change goes through a variation, not an edit.
- Variation requests classified by configurable type
- Requirement templates per type, copied as a checklist onto each request
- Multi-stage approval from draft through review to approved
- An approved variation authorises the new formula or method version
08 / 08
Quality Events
Deviations, CAPA and change control beside the R&D records they touch.
- Deviations, OOS and OOT investigations by type and severity
- CAPAs and their actions, through to an effectiveness check
- Change controls with impact assessments and implementation tasks
- Training records per employee and SOP, with validity dates
Method Validation
A validated method is a record, not a binder
Each validation lists its ICH Q2(R2) parameters with the acceptance criterion, the result and a pass or fail. Once approved it is signed and locked, and the method of analysis it supports becomes read-only for QC.
- Specificity, linearity, range, accuracy, precision, LOD, LOQ, robustness, system suitability.
- A linearity helper turns x/y points into slope, intercept and r².
- Signatures shown on the record, with their meaning and time.
Stability
Stability results that check themselves
Every time-point result is compared with the effective specification and with the trend of earlier points. Long-term data gives a shelf-life estimate, and a failing result can be sent back to formulation as a new formulation request.
- Out of specification against the registered limits.
- Out of trend against a 99% prediction interval.
- Shelf life from the one-sided 95% confidence bound, capped as ICH Q1E allows.
Audit Trail
Who changed what on this product, and why
Every create, update and delete on a regulated record is written in the same transaction as the change, with the user, the time, the fields that changed and the reason. The product page shows its own trail.
- Before and after values for every changed field.
- A reason is required to change or delete a regulated record.
- Deleted records are kept, with who deleted them and why.
Inspection Ready
What a Regulatory Reviewer Checks, and How the Records Answer It
Does Module 3 match the formula on file?
Formula versions, the trials behind them and the pilot batches that passed sit on the same product the dossier is filed for.
Are the methods validated and controlled?
Each method of analysis links to its ICH Q2 validation, and an approved validation is signed and locked.
Does stability support the shelf life?
Results are checked for OOS and OOT as they are entered, and the shelf-life estimate comes from the long-term data itself.
Was the registered product changed?
Once a licence is approved, composition and methods are read-only; a new version needs an approved variation.
Global Compliance
Built Around the Guidelines Reviewers Apply
The technical controls in RENOVA-RDX map to the regulations and guidelines below. Each card names the control that answers it.
EU GMP Annex 11
Computerised systems
Role-based access per module, an audit trail written in the same transaction as each change, and account lockout after repeated failed sign-ins.
ALCOA+
Data integrity
Every write is attributed to a user and time, approved records are locked, and deletes keep the record with a reason instead of erasing it.
ICH Q1A(R2) & Q1E
Stability testing and evaluation
Five study types, OOS and OOT flags on every result, and a shelf-life estimate with the Q1E extrapolation limit.
ICH Q2(R2)
Analytical procedure validation
Validation parameters with acceptance criteria and pass/fail, plus a linearity regression with slope, intercept and r².
ICH M4 · CTD
Common Technical Document
Each dossier starts with a Module 1–5 checklist and tracks its submission sequences and authority references.
ICH Q8(R2)
Pharmaceutical development
Versioned development reports beside the trials, excipient compatibility studies and scale-up batches they summarise.
ICH Q10
Pharmaceutical quality system
Deviations listed on each product, CAPA with an effectiveness check, and change control with impact assessments.
Post-Approval Variations
Registered = locked
An approved licence makes composition and methods read-only; a new formula or method version needs an approved variation.
GAMP 5
Risk-based validation
Validated by the Corpex team with a risk-based approach and IQ, OQ and PQ documentation; see CSV services.
Designed to the expectations of
- US FDAUnited States
- EMAEuropean Union
- MHRAUnited Kingdom
- PIC/SInspection co-operation scheme
- WHOWorld Health Organization
- ICHHarmonised guidelines
Compliance belongs to the validated system and the procedures around it. RENOVA-RDX supplies the technical controls, and the Corpex validation team documents them for your inspection. RENOVA-RDX tracks dossiers and sequences; it does not publish eCTD files to an authority gateway.
R&D and Regulatory Affairs
One R&D Record for Every Market You File In
A registration dossier is only as good as the records behind it. RENOVA-RDX keeps those records with the product, works alongside CORPEX-LIMS for QC data and CORPEX eQMS for document control and change management, and is validated like any other GxP system through computer system validation (CSV). See the wider suite on the regulatory affairs software and pharmaceutical software solutions pages.
Any authority, any market
Dossiers are recorded per country and authority, so one product can carry national, regional and renewal filings side by side.
Many companies, one portfolio
Products sit under their owner company, and every list can be filtered by company and product.
Your servers, implemented with you
Runs on your servers or private cloud; configuration, data migration, training and validation by the Corpex team.
See a Product Go From Trial to Registration
Book a demo and we will walk one product through formulation, method validation, stability and its dossier with you.
Request a DemoRENOVA-RDX — Frequently Asked Questions
What is RENOVA-RDX used for?
RENOVA-RDX is pharmaceutical R&D software that manages formulation, analytical methods, stability studies and regulatory affairs for one or more products across multiple dosage forms, so R&D and regulatory teams work from the same records instead of separate spreadsheets and folders.
Does RENOVA-RDX handle eCTD publishing or submission to health authority gateways?
RENOVA-RDX manages dossier compilation, registration tracking, renewal alerts and correspondence tracking with authorities, with eCTD support readiness built in. It does not publish to or submit through a specific health authority's electronic gateway — confirm the publishing and submission tools your target markets require with your regulatory team.
How does RENOVA-RDX support stability studies for CTD submissions?
The Stability module schedules pull points and chamber monitoring, tracks degradation trends, and produces shelf-life data compliant with ICH guidelines — the evidence a CTD Module 3 quality section needs to support a claimed shelf life.
Can RENOVA-RDX integrate with our QC lab and quality system?
Yes. RENOVA-RDX is part of the CORPEX platform, so Certificates of Analysis and specification data from CORPEX-LIMS, and SOPs and change records from CORPEX eQMS, connect to the same product record without re-keying.
Is RENOVA-RDX validated for GxP use?
RENOVA-RDX implementations are validated through CORPEX's computer system validation (CSV) service — a Validation Master Plan, IQ/OQ/PQ execution and traceability from user requirements to test evidence — so the system is inspection-ready at go-live.
Does RENOVA-RDX support national registration authority requirements?
Yes. Dossiers are recorded per country and authority, each starting from the CTD Module 1 to 5 checklist with its submission sequences, while the Registration and Approvals tabs track naming, pricing, scientific and quality approvals and licences for whichever national authority the product is filed with.