Frequently Asked Questions

Validation ensures that the computerized systems are fit for intended use and compliant with applicable regulations.

If there is anything amiss in an FDA-regulated manufacturer’s computer system it could ultimately impact patient safety, product quality and your reputation.

All FDA-regulated manufacturers. Optionally, this can extend to client’s ERP vendors.

ERP Validation Toolkit, a complete package of all the deliverables required for validation. It consists of test scripts, templates and necessary documents and screenshots.

Most Independent verification and validation organizations who provide toolkit services, have documentation containing generic examples only, without software-specific processes and screen shots. Because center work solely with BatchMaster and the ERP systems center know, center toolkit documentation includes expertise on both software and regulatory requirements. Many Validation projects fail to get off the ground because the staff required to do it simply don’t know where to start.  Pre-filled documents give client a great start, answering those panic questions which typify the introduction of a validation project. This head-start takes client along a rapid road to complete validation, saving client’s both time and money! And client have an added advantage of working with a team having dual expertise in his software and regulatory compliance.

“A drug shall be deemed adulterated if: … the methods used in, or the facilities or controls used for, its manufacture, processing, packing, or holding do not conform to or are not operated or administered in conformity with current good manufacturing practice …”. Software Validation confirms that the system and processes are aligned with cGMP guidelines (FDA 21 CFR Part 211, 820)

A standard operating procedure (SOP) manual is a compilation of all the SOPs, documented to ensure that products are consistently produced and controlled according to quality standards

A standard operating procedure, or SOP, is a set of step-by-step instructions compiled by an organization to help workers carry out complex routine operations. SOPs aim to achieve efficiency, quality output and uniformity of performance, while reducing miscommunication and failure to comply with industry regulations.

GMP Validation Center proprietary validation toolkit is a complete package and contains all the deliverables expected as per GAMP 5 guidelines. Test scripts are prepared based on cGMP guidelines defined in Part 210, 211 and Part 820. The Toolkit contains both test and executed scripts based on cGMP requirements and using BatchMaster software processes and screenshots. For deliverable documents, templates are provided where you only have to enter your business-specific information. You use cGMP based test and executed test scripts with your actual items, and provide factual information in the templates for document preparation during software validation. The Validation Center’s intellectual property toolkit remains with you for your continued use and reference.

The process involves 3 phases: Planning, Testing and Summarizing. The initial Planning phase involves gathering information and documenting it, conducting risk assessments, and transferring your SOPs into User Requirement Specifications. Draft, and get approval of, various test scripts like FRS, DQ, IQ, OQ, and documents like the Master Validation Plan. The MVP defines the complete validation strategy and expected deliverables. In the testing phase, test scripts prepared during the planning phase are executed in the production environment, and the results are recorded. In the summary phase, the results of the execution phase are analyzed, approved and archived. Once all phases are complete, you have a complete validated system.

• Master Plan Template
• Risk Assessment Templates and Specifications
• User Requirements Specification for software and FDA cGMP (21 CFR Part 210, 211)
• Installation Qualification Test Scripts (IQ)
• Solution Document Test Scripts (SD)
• Operational Qualification Test Scripts (OQ)
• Performance Qualification Test Scripts (PQ)
• 21 CFR Part 11 Compliance Assessment template and document
• Requirements Trace Matrix and cGMP Trace Matrix
• Migration Plan Template
• Change Request Template
• Disaster Recovery Plan Template
• Validation Summary Document Template
• Validation System Security Plan

SOP services offered by GMP Validation Center are optional services provided to clients who do not have streamlined Risk-based documented processes. Our experts create your SOP’s with the help of your staff. Your SOP design includes information on product, process and regulatory requirements. SOPs are unique to the way you choose to operate your business, and how your software setup options are configured, including policies you may have around pre-filled data on various screens, for example. They need to be very detailed, practically user cheat-sheets, and of course they must be risk-based in accordance with cGMP requirements. SOP services are a specialized project on its own, and the GMP Validation Center provides a full service to guide you through it.

If you choose our complete validation service, the Center will conduct all the Planning and Requirements Capture tasks in cooperation with your staff. The first phase of planning is to review your SOPs.  If you don’t have them documented already, the Center can give you guidance or work with you to create them. Translate company specific SOPs (cGMP, Process, Product) information into URS and risk assessments. Leveraging the validation toolkit, prepare both test and executable scripts and deliverable documents using templates with company specific information. CFR part 11 documents provided with the validation toolkit, along with the scripts and documents described, are compiled as the Master Validation Plan. Remaining information for the Master Validation Plan is entered in the template. And, of course, this service continues through the Execution and Summary Phases.

The initial planning phase activities are divided into two parts: Planning and Requirements Capturing. The first phase of planning is to review your SOPs. The next step is to review & document your physical computer setup, including any new equipment or proposed changes, and resulting in Draft Supplier Audit documents. The Risk Assessments are done next. The Requirements Capturing Phase is where your SOPs are transferred into User Requirement Specifications to drive the testing. This part includes documenting any software customizations required, specifications for new hardware if this is proposed; and lastly reviewing and approving the URSs.

Tasks are performed in the Execution Phase under the categories: Installation Qualification, Operational Qualification, Performance Qualification, and User Acceptance Tests. Note, under Performance Qualification, the item “Verify Concurrent Session & Transactions”.  If you have licenses for 100 users, then the performance needs to be checked with all 100 users logged in and performing work.

In the final phase, once all testing is complete, the Validation Summary Report is finalized. All system changes are reviewed, changes incorporated in client’s SOPs, closing the loop on the complete validation, Validation Summary Report is approved, Performance Qualification tests will be repeated over the next 2-3 months, and Incident Reports collected during that on-going testing. Finally, all documentation is archived both electronically and on paper, to make it easily available to the FDA during a site audit, and of course for your own staff.

Regulatory agency which regulates life science products in the USA is the FDA, in Europe it is ICH, and in Japan and China they have their own regulatory agencies.

“GxP regulated Computerized systems” are defined as the systems that keep information related to Good Manufacturing Practice (GMP), Good Clinical Practice (GCP), Good Laboratory Practice (GLP), Good Distribution Practice (GDP). According to FDA guidelines, a computer-related system is considered to be GxP if it impacts, or has the potential to impact, product quality (safety, quality, integrity, purity or potency).  It is also a GxP system if it performs a function specifically governed by cGMP regulations.

The Food and Drug Administration (FDA) is a regulatory agency in the USA and is a part of the Department of Health and Human Services. Currently it regulates $1 trillion worth of products a year. It ensures the safety of all food except for meat, poultry and some egg products; ensures the safety and effectiveness of all drugs, biological products (including blood, vaccines and tissues for transplantation), medical devices, and animal drugs and feed; and makes sure that cosmetics and medical and consumer products that emit radiation do no harm. Recently, in August 2009, tobacco products have also been included in the list of regulated products.

The cGMP regulations for drugs contain minimum requirements for the methods, facilities, and controls used in manufacturing, processing, and packing of a drug product, and the strength it claims to have.