Services and catalog
Validate, qualify, sustain. All with one team.
Eight service lines designed for every stage of the lifecycle: from the supplier's factory to the system in production, the software that simplifies it and the plan that protects it.
Three families
Choose by the problem, not by the regulation.
01 / 03
Systems and data
So every GxP system, spreadsheet and data point is reliable and defensible, and repetitive work gets automated.
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QA·IT
IT quality management
Without an inventory, criticality and QA IT policies, every validation starts from scratch.- GxP inventory
- GAMP 5
- PIC/S PI 011-3
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CSV
System validation (CSV)
LIMS, ERP, MES, SCADA or QMS that must prove they do what they claim.- GAMP 5 Second Edition
- 21 CFR Part 11
- EU GMP Annex 11
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XLS
Excel spreadsheet validation
Spreadsheets that calculate results, yields or stability and that nobody has validated.- GAMP 5
- 21 CFR Part 11
- EU GMP Annex 11
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DEV
Software development
Manual tasks, endless spreadsheets and processes that eat up your team's hours.- Custom software
- Automation
- Smart Inventory
02 / 03
Processes, areas and equipment
To prove that your plant and your processes do what they are supposed to do, every time.
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PV
Process validation
Manufacturing processes that must demonstrate consistent results, batch after batch.- FDA PV Guidance 2011
- EU GMP Annex 15
- ICH Q9(R1)
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C&Q
Qualification, mapping, FAT and SAT
New equipment, cleanrooms, warehouses and cold rooms that need to be qualified.- ISO 14644
- EU GMP Annex 1
- EU GMP Annex 15
03 / 03
Documentation and continuity
So operations are written down, understood and ready for the unexpected.
Full catalog
Everything we can do.
Filter by family or type of work, or search for an activity. Each item takes you to the service that includes it.
47 capabilities
- AssessmentGxP computerized system inventoryIT quality management
- AssessmentGxP criticality classification and GAMP 5 categoryIT quality management
- AssessmentCritical data flow mapping (ALCOA+)IT quality management
- DocumentationQA IT life cycle policiesIT quality management
- DocumentationChange, incident, access and backup proceduresIT quality management
- AssessmentInspection readiness for systemsIT quality management
- DocumentationValidation Master Plan (VMP)System validation (CSV)
- DocumentationURS, FS and DS specificationsSystem validation (CSV)
- AssessmentFunctional risk assessment (ICH Q9)System validation (CSV)
- ExecutionSystem IQ / OQ / PQ protocols and executionSystem validation (CSV)
- DocumentationRequirements traceability matrix (RTM)System validation (CSV)
- AssessmentPart 11 / Annex 11 assessment: audit trail, signatures and accessSystem validation (CSV)
- DocumentationValidation report and GxP releaseSystem validation (CSV)
- ExecutionPeriodic review and revalidationSystem validation (CSV)
- AssessmentSpreadsheet inventory and GxP impact assessmentExcel spreadsheet validation
- ExecutionValidation of spreadsheets with formulas, macros and VBAExcel spreadsheet validation
- ExecutionFormula protection, versioning and access controlExcel spreadsheet validation
- DocumentationChange control for validated spreadsheetsExcel spreadsheet validation
- ExecutionCustom software development for identified processesSoftware development
- ExecutionAutomation of repetitive tasks and reportsSoftware development
- ExecutionTools to organize and consolidate scattered dataSoftware development
- ExecutionDRP Smart Inventory: GxP laboratory inventorySoftware development
- DocumentationValidation-ready development documentation (GAMP 5 Cat. 5)Software development
- AssessmentIdentification of critical parameters and attributes (CPP/CQA)Process validation
- DocumentationProcess validation protocols (PPQ)Process validation
- DocumentationSampling plans and acceptance criteriaProcess validation
- DocumentationStatistical framework and process capabilityProcess validation
- DocumentationContinued process verification programProcess validation
- ExecutionFAT at the supplier's plantQualification, mapping, FAT and SAT
- ExecutionSAT at your siteQualification, mapping, FAT and SAT
- ExecutionIQ / OQ / PQ of equipment and utilitiesQualification, mapping, FAT and SAT
- ExecutionCleanroom classification (ISO 14644 · Annex 1)Qualification, mapping, FAT and SAT
- ExecutionTemperature mapping of warehouses, cold rooms and areasQualification, mapping, FAT and SAT
- DocumentationStatistical analysis of mapping data (hot/cold spots)Qualification, mapping, FAT and SAT
- DocumentationQualification Plan and periodic requalificationQualification, mapping, FAT and SAT
- AssessmentDocumentation gap analysis against GMPSOP development
- DocumentationDocument coding system and hierarchySOP development
- DocumentationMaster SOP templateSOP development
- DocumentationWriting SOPs, work instructions and formsSOP development
- DocumentationDocument Control ProcedureSOP development
- TrainingDocument management trainingSOP development
- AssessmentIT risk and vulnerability assessmentDisaster recovery (DRP)
- AssessmentBusiness impact analysis (BIA) with RTO and RPODisaster recovery (DRP)
- DocumentationBackup and recovery strategiesDisaster recovery (DRP)
- DocumentationDocumented Disaster Recovery PlanDisaster recovery (DRP)
- ExecutionRecovery drills and testingDisaster recovery (DRP)
- TrainingResponse team trainingDisaster recovery (DRP)
We could not find that activity in the catalog. Tell us what you need and we will look into it.
In-house development
If it repeats, automate it.
When we spot a problem or a process that can be simplified, we build the program that solves it. And for day-to-day laboratory work, we have our own product: DRP Smart Inventory.
Explore the service- 1DetectThe manual process or problem holding your team back.
- 2SimplifyFewer steps, fewer errors, no double data entry.
- 3AutomateA custom program that does the repetitive work.
- 4SustainDocumented and ready to validate per GAMP 5.
DRP Smart Inventory
- GxP inventory in one placeMaterials and reagents, standards, equipment, computerized systems and suppliers.
- Expiry dates and alertsStock, calibrations, maintenance and revalidations that never slip through the cracks.
- Full traceabilityAn audit trail for every operation, designed for Part 11 and Annex 11.
- Equipment histories and reportsThe history of every piece of equipment or system, ready for an inspection.
Next step
Be ready for your next
regulatory challenge.
Tell us what you need to validate, qualify or document. In the first conversation we get to know your operation and tell you how we would approach it.