Pharmaceutical Industry Software

Enterprise Quality Management Software for Pharmaceutical

Systek provides software’s for Pharmaceutical Manufacturing Industry, Medical Stores and MR Reporting with the most relevant and recent features available in them.

 Systek Team has strong domain experience in Pharmaceutical Verticals because of constant ERP and Other Software Services provided successfully by us to this Industry. Systek provides SAP Business One along with Add On Modules for taking care of this vertical of business. This is end to end solution for Pharmaceutical Industry. In addition to SAP Business One Standard Modules we develop additional modules to accommodate typical requirements of Pharmaceutical Industry related to Production – Production Planning, Production Scheduling, Quality Control, Stability, Export-Import (EXIM), Transportation, Payroll, Customer and Supplier / Vendor Collaboration, Warehouse Management.

Systek Team has strong domain experience in Pharmaceutical Verticals because of constant ERP and Other Software Services provided successfully by us to this Industry. Systek provides SAP Business One along with Add On Modules for taking care of this vertical of business. This is end to end solution for Pharmaceutical Industry. In addition to SAP Business One Standard Modules we develop additional modules to accommodate typical requirements of Pharmaceutical Industry related to Production – Production Planning, Production Scheduling, Quality Control, Stability, Export-Import (EXIM), Transportation, Payroll, Customer and Supplier / Vendor Collaboration, Warehouse Management.

Systek also provides other Software’s / ERP for Pharmaceutical Industries covering all the Normal Processes and Statutory Requirements like BPR (Batch Process Records), BMR (Batch Manufacturing Records) in order to comply with requirements of Regulatory Standards like FDA, MHRA, etc.

Globally, the Pharmaceutical Industry has the need for timely and accurate manufacturing information that can be Collected, Stored, Retrieved, Analyzed and Reported more readily. The only option for efficiently managing these Batch Records is to automate the process.

Challenges faced in Manual Batch Record Management System
  • Cumbersome and Repetitive Documentation due to similar data appearing at many places
  • Manual data is prone to Human Errors and becomes difficult for cGMP compliance
  • Version Management and Integrity of Templates becomes difficult
  • Retrieval of Records is time consuming
  • Substantial time is spent on Review and Approval Process
  • Maintaining Audit Trails of various processes is tedious

21CFR Part 11 guidelines and automation of Batch Records with the advent of 21 CFR Part 11, the FDA has begun to accept Electronic Batch Records. Since then, more and more manufacturers have recognized the advantages of automating the process of controlling Electronic Batch Records (EBR).

Under cGMP Regulations found in 21 CFR Parts 210 and 211, the Electronic Batch Record (EBR) must demonstrate the accomplishment of every significant step in Production, Packing and Holding of each Batch of a Drug Product. cGMP requires extensive Batch Record Documentation, including Batch Dates, Identity of Major Equipment / Lines Used, Components / Materials Used and their Weights, In-Process and Laboratory Control Results, Complete Labeling Control Record

SAP Business one - systek

Testimonials

"I am very pleased with your Project Management capability. Your team has excellent communication skills and a fast response and turnaround time. Highest work quality. I can say that SYSTEK and the team at Smart Software Solutions is an honest"

Michael Tyson