Services

We are providing following CSV Validation services but is not limited to:

•  PLC/HMI/IPC/SCADA System Validation

• Control system and Software Validation

• Computerized System Validation

• EMS (Environment Management System) & BMS (Building Management System) Validation

• Warehouse Management System Validation

• Manufacturing Execution System Validation

• Laboratory Software and Analytical Software Validation service

• Excel sheet/Spread sheet Development and Validation (as per 21 CFR Part 11)

• Any type Customized Software Validation 

• CSV Validation documents review

Our Validation protocols is as per current GAMP guideline and fulfill 21 CFR, Part 11 Compliances.

We put our unique combination of leading industries knowledge, breadth of experience and proven process for you- providing information you need to deliver safe, effective and quality products every time. 

Compliance to the regulations is becoming a global and complex scenario putting incease demands on a company`s time and recourse. Pharmaceuticals, Biotechnology and mediccal device manufacturing must observe national and international legislation to incease product safety and ensure the health of consumers.

HURDLES IN THE WAY OF COMPLIANCE

• How to balance the ongoing changes in the indusry and the implementation of the new technologies with the need for Compliance ?

• How to find time and resources to stay up to date with regulatory developments and to be constantly prepared for an inspection ?

• How to meet consumer demand for high quality standards at good prices in soughed economies.

excel / spread sheet development & validation

Spreadsheets in regulated industries

Using speradsheets in a regulated envirornment for GxP Purposes whether as an operator interface, as a data manipulation tool or for data storage, it comes with a lot of responsibility through how so ever simple it may appear to use.

Log-on security for the application and spreadsheets, independent audit trail, electronic signatures, data security, authorizations are the key implications of the rule 21 CFR Part 11.

laboratory software validation 

In January 2002, the FDA issued the general principles of software validation. This guidence applies to any computerized system and software in the life science industry that is used to automate device design, testing, component acceptance, manufacturing, labelling, packing, distribution or complaint handling for quaility system.

In addition, Computer System that are use to create, modify and maintain electronic records and to manage electronic signatures are also subject to validation requirements.

Rules and regulation for Laboratory systems can be found in 21 CFR 211 (Good Manufacturing Practice), 21 CFR 58 (Good Laboratory Practice), 21 CFR 820 (Quality System regulation for Medical devices), 21 CFR Part 11

The FDA  considers software validation to be confirmation by examination and provision of objective evidence that software specifications conform the user needs and intended uses and that particular requirements implemented through software can be consistently fulfilled.