Pharmaceutical Water
Electrodeionisation (EDI): URS and qualification document flow
The User Requirement Specification is the first document in the qualification set, and the one every later verification traces back to. Pharma4i generates the URS today. The rest of this flow is shown so the scope is clear; those documents are marked Soon and are not produced by the product.
- Generated by Pharma4i today
- Not generated yet — marked Soon
- Connector lines show which documents trace back to the URS.
Qualification document flow for a electrodeionisation (edi).
Your URS is the input to every document to its right. Each requirement carries an ID so verification can be traced back to it.
What is specific to a electrodeionisation (edi)
Design Qualification DQ
Carries CSV-specific content per GAMP 5: the design is reviewed against the software category, the supplier assessment outcome and the data integrity requirements.
Operational Qualification OQ
Carries CSV-specific content per GAMP 5: configured functions, security and access control, audit trail, electronic records and electronic signatures.
PQ Phase 1 — intensive sampling PQ-1
Daily sampling of all points, including each point of use, to establish the system can consistently produce water of the specified quality.
PQ Phase 2 — sanitisation regime PQ-2
Sampling continues at the same frequency while the proposed operating and sanitisation procedures are followed; water may be used in manufacturing at the site's risk once Phase 1 is satisfactory.
PQ Phase 3 — one year, seasonal variation PQ-3
Runs for twelve months so that seasonal changes in feedwater temperature and quality are captured. This is the most commonly underestimated qualification in the industry: the system is not fully qualified until Phase 3 is complete.
Cleaning Validation CV
Acceptance limits derive from the permitted daily exposure (PDE) for the product, not from arbitrary dose or 10 ppm rules; sampling covers worst-case surfaces and hold times.
The document set
| Document | Abbr. | Owner | Purpose | Traces to URS | Status |
|---|---|---|---|---|---|
| User Requirement Specification | URS | user | States what the equipment must do, in verifiable requirements owned by the user. | — | Available |
| Supplier Assessment | SA | user | Assesses the supplier's quality system to set how much of their testing can be leveraged. | — | Soon |
| Quality Risk Assessment | QRA | joint | Identifies risks to product quality and patient safety, and sets qualification scope. | Yes | Soon |
| Functional Specification | FS | supplier | Describes the functions the supplier will provide to satisfy each requirement. | Yes | Soon |
| Design Specification | DS | supplier | Records how those functions are engineered, in detail sufficient to build from. | Yes | Soon |
| Configuration Specification | CS | joint | Records every configurable parameter, user role and workflow setting as applied. | Yes | Soon |
| Design Qualification | DQ | joint | Verifies the proposed design against the URS before fabrication is released. | Yes | Soon |
| Factory Acceptance Test | FAT | supplier | Tests the assembled equipment at the supplier works before shipment. | Yes | Soon |
| Site Acceptance Test | SAT | joint | Repeats critical tests on site after delivery and connection to site services. | Yes | Soon |
| Installation Qualification | IQ | user | Documents that the equipment is installed as specified, with services verified. | Yes | Soon |
| Operational Qualification | OQ | user | Demonstrates the equipment operates across its specified ranges. | Yes | Soon |
| Requirements Traceability Matrix | RTM | user | Maps every requirement to the test that verifies it, and back again. | Yes | Soon |
| PQ Phase 1 — intensive sampling | PQ-1 | user | Two to four weeks of daily sampling at every use point, before water is released for manufacturing. | Yes | Soon |
| PQ Phase 2 — sanitisation regime | PQ-2 | user | A further two to four weeks confirming the routine sanitisation regime holds quality. | Yes | Soon |
| PQ Phase 3 — one year, seasonal variation | PQ-3 | user | One full year of reduced-frequency sampling covering seasonal feedwater variation. | Yes | Soon |
| Cleaning Validation | CV | user | Demonstrates the cleaning procedure removes residues to a health-based limit. | Yes | Soon |
| Validation Summary Report | VSR | user | Concludes the qualification, resolves deviations and releases the equipment for use. | Yes | Soon |
| Periodic Review / Requalification | PR | user | Confirms at intervals that the equipment remains in its qualified state. | Yes | Soon |