- 2applications: PMS and BSMS
- 12store inventories managed in PMS
- e-signon key actions, with an audit trail
- .NETwith an SQL database
The challenge
Every material and sample has to be accounted for, approved, signed and traceable.
Pharmaceutical stores and laboratories handle materials and samples that must be accounted for at every step. Active ingredients, columns, working standards, equipment and bio-samples are received, requested, issued, transferred, extended or discarded, and each of those actions must be approved, signed by the right person and traceable afterwards.
When this work runs on paper forms and separate records, it is slow, and it is hard to show who did what and when. Teams also need to know the status and storage location of each material or sample at any moment, and they need reports ready for review.
Sun Pharma needed regulated stores and laboratories to work in a controlled, traceable way, with approvals and electronic signatures built into the daily work.
What we built
Catabatic built two applications for Sun Pharma: the Pharmacy Management System (PMS) for store inventories, and the Bio-Sample Management System (BSMS) for bio-samples and studies. Both are built for GxP and designed to meet the requirements of 21 CFR Part 11 for electronic records and electronic signatures.
PMS: Pharmacy Management System
Twelve inventories. Every action listed is signed electronically.
API
Receipt and receipt approval, requisition, issuance, discard request and discard approval.
Columns
Receipt and approval, requisition, issuance, return, transfer and transfer approval, discard request and approval.
Store
Receipt and approval, requisition, issuance, discard request and approval.
CPP IP, CPU IP and MPS IP
Receipt and approval, transfer request and approval, discard request and approval, expiry extension and its approval.
DFL
Receipt and approval, requisition, issuance, transfer and transfer approval, discard request and approval.
Impurity and working standards
Receipt and approval, requisition, issuance, return, transfer and transfer approval, discard request and approval.
Innovator and excipient
Receipt and approval, requisition, issuance, discard request and approval.
Equipment
Receipt and approval, requisition, issuance, transfer and approval, calibration, breakdown, servicing, preventive maintenance, PPV, discard request and approval.
Stability
Receipt and approval, requisition, issuance, discard request and approval.
BSMS: project and sample management (CPP)
Projects, receipts, issuance, inventory, transfers and discards.
Dashboard
Pending notifications and tasks. A user opens a notification and takes the action it needs.
Plan a project
Create a project with its details, matrix, coordinator and supporting information. Bio-sample projects are configured with subjects, groups, timepoints and reconciliation details.
Receipts
Receive clinical bio-samples and blank matrix samples, by scanning or by manual selection. If planned samples do not arrive, the remaining ones are marked missing.
Issuance request and segregation
Request samples or material. Staff segregate the actual samples to issue, and only segregated samples move to issuance.
Analyst inventory
Sample and material status (available, logged in, logged out, consumed) with a logbook of related activity.
Transfer and bulk movement
Move clinical samples between locations or sites with e-signature and destination-side approval. Move several samples together by equipment, location or project.
Discard and extend expiry
Discard samples or a project, or extend expiry, through the approval flow.
Search, reports and audit trail
Find records, view details, export information and follow the history of every activity.
BSMS: study processing (CPU)
Studies, aliquots, separation, segregation, labels and storage.
Dashboard
Notifications and pending study activities for the logged-in user.
Create study and configure aliquots
Create a study and define its aliquot configuration. The study list shows each configured record and its status.
Reconciliation grid
Subjects and timepoints with Yes or No values. Bulk selection is available and single values can still be corrected.
Bleed sheet sync
Sync collection information by period and timepoint, or sync all applicable timepoints at once.
Sample separation
Convert vacutainers to aliquots by barcode scanning for the selected study, period and timepoint. Buffer studies are supported, with an extra aliquot scan where needed.
Sample segregation
Segregate samples for the next activity. If the related separation record is pending approval, the system blocks further processing.
Pouches and labels
Filter, create and print timepoint-wise pouch and label information.
Search, export and storage
Search by study number, period, timepoint, storage, rack, shelf and status. Export list screens to PDF, Excel or ZIP. Every sample keeps its storage location so its movement can be traced.
Built in to every step
Compliance is part of the work, not added afterwards.
Electronic signature
Each key action in PMS is signed electronically by the responsible user. Review, approval, verification and signature are also part of BSMS.
Audit trail
Every transaction is recorded, so users can see who did what and when.
Accountability
Every transaction appears in the accountability record, with multiple reports for each inventory.
Role-based access
Users see only the screens and actions their role allows.
GxP and 21 CFR Part 11
Both applications are built for GxP and designed to meet the requirements of 21 CFR Part 11 for electronic records and electronic signatures.
How it works day to day
- 1
Set up
Projects and studies are created, and subjects, timepoints and aliquots are configured. Users are given roles, so each person sees only what they are allowed to do.
- 2
Receive
Materials are received into the store and approved with an e-signature. Samples are received by scanning or selection, or synced from the bleed sheet. Missing samples are marked.
- 3
Process
Vacutainers are converted to aliquots by barcode scanning. Samples are then segregated for the next activity, and pouches and labels are printed by timepoint.
- 4
Store, issue and transfer
Materials are requested, approved and issued. Samples and materials are transferred, moved in bulk, returned or consumed. Storage location and status stay up to date.
- 5
Close and prove
Expiry is extended or items are discarded through approval. Records can be searched, reports exported to PDF, Excel or ZIP, and the audit trail shows the history of every activity.
In use
Where it runs
Built for Sun Pharma.
Who uses it
Staff in the stores and laboratories. Each user sees only the screens and actions allowed for their role.
Technology
Built on .NET with an SQL database.
Regulated stores and labs to run?
Tell us about your inventories and your approvals. We will reply with how we would build it.