Software Requirements

Specification
for

Regulatory Information
Management System
Version 1.0

Prepared by: Zahid Mashhood

Date: November 18th, 2016.

Software Requirements Specification for Regulatory Information Management

System
Page 1

Current System
Business Development department submits request for product
registration, to Regulatory Affairs (RA) department by manually filling-in
Product Information Sheet (PIS). The PIS contains all necessary information
required for the product registration process. RA department drafts the
dossiers, and then submits the request for product registration to Ministry of
Health (MOH) Islamabad through Form-5, and Form-5D. If MOH meetings
discuss the submitted product of Pharma, and it makes progress, the RA
department updates the products status in Product Registration Control Sheet
(PRCS). PRCS contains key information about each registered/un-registered
product.
During the dossier preparation, RA requires product references from
previous MOH Meeting-Minutes; RA has to search more than 250 files for any
reference availability.
RA department maintains the whole above defined process manually,
which is difficult to update, and time consuming.

Proposed System
We propose RIMS a central Regulatory Information Management
System that acts as a single source of information which, accurately tracks all
regulatory activities, automates the entire registration and tracking process.
Business Development (BD) officer will initiate process by entering
product information in RIMS, master records will be created where List of
Values (LOVs) are required; for instance, the dosage form, therapeutic class,
packing type, and etc. The system will auto assign a reference number to the
submitted request; all the tracking process will be monitored through this autoassigned reference number. The request will be approved by the Head of BD,
and then will be forwarded to RA department.
RA department will attach the dossier file in MS-Word format and enter
the date of the product registration request in the system. The dossiers will be
sent to MOH; if the product is registered or unregistered, RA will update
information in RIMS, e.g. the registration number, reg. date, reg. expiry date,

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System
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pack size, and product packaging, etc. Likewise, if the product is deferred for
registration or rejected, RA will update the status and reason for rejection of
the product in RIMS.
RIMS will provide us basic product reports based on master data and
transaction like;

Dosage Form
Therapeutic Class
Under-registration
Registered
Rejected
Status and,
Near reg. expiry.

We propose a solution for searching for any text values in MoH meetings
minute files within RIMS or by any other 3rd party Regular Expression search
utility.

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