Biotech Upstream
Cell bank and cold storage (−20 °C, −80 °C, LN2): 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 cell bank and cold storage (−20 °c, −80 °c, ln2).
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 cell bank and cold storage (−20 °c, −80 °c, ln2)
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.
Biosafety Containment Verification BCV
Covers room pressure cascade, airlock behaviour, HEPA housing integrity and effluent containment for live organism handling.
Operational Qualification OQ
Carries CSV-specific content per GAMP 5: configured functions, security and access control, audit trail, electronic records and electronic signatures.
Decontamination Cycle Validation DCV
Biological indicator challenge of the vaporised agent or chemical cycle, including inactivation of the live organism handled.
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 |
| Biosafety Containment Verification | BCV | joint | Verifies primary and secondary containment for the biosafety level handled. | Yes | Soon |
| Operational Qualification | OQ | user | Demonstrates the equipment operates across its specified ranges. | Yes | Soon |
| Decontamination Cycle Validation | DCV | user | Validates the decontamination cycle used before maintenance or product changeover. | Yes | Soon |
| Requirements Traceability Matrix | RTM | user | Maps every requirement to the test that verifies it, and back again. | Yes | Soon |
| Performance Qualification | PQ | user | Demonstrates sustained performance with the intended product and process. | 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 |