16+

countries

86+

customers

203+

projects

40+

yrs of industry experience

About Us

We help companies manage regulatory compliance through seamless integrations of best-of-the-breed DMS, QMS, LMS, ERP and LIMS on cloud or on premise. The integrations and services offer better customer experience and business efficiency.

Our

SOLUTIONS

Print Control Services TM (PCS)

FDA says, "If it isn't written down , then it didn't happen".

Print Control Services consists of two components, Controlled Print Services (CPS) and Issued Print Services (IPS). Prints are completed in real-time and both services are necessary to meet Data Integrity Guidelines (21CFR 211.192, 211.194, 212.50, 212.70.f.vi and EMA Guidance GMP) for regulatory agency audits. This is compatible with cloud and on-premise environment.

Issued Print Services

Issued Print Services TM

IPS allows businesses to seamlessly manage prints and reprints of GxP documents (Example: Validation protocols and Batch records). It also allows reconciliation of executed issued prints and reprints.
Controlled Print Services

Controlled Print Services TM

CPS allows businesses to seamlessly manage prints and reprints of GxP documents (Example: SOPs, WIs). It also allows recall of controlled prints and reprints.
On-Premise Ready

Cloud Ready

On-Premise Ready

On-Premise Ready

Proficio TM

Proficio allows integration of DMS with one or more Learning Management Systems (LMS) either on-premise or cloud. It also enables
bi-directional data exchange in real-time to maintain compliance.

Effortless control

Effortless control

Configurable versus customized
On-Premise Ready

Seamless Experience

Connection with multiple LMSs (could be GxP and non-GxP)
Log every step

Log every step

Easy to implement pre and post approval business rules
On-Premise Ready

Cloud Ready

On-Premise Ready

On-Premise Ready

Synapsys TM

Synapsys solution allows businesses to connect, in real-time with a DMS repository
and Quality Management System (QMS) of choice.

Synapsys

Quick integration

Connect DMS and QMS for end-to-end capability with minimum manual hand-offs
Synapsys

Minimize time & cost

Leverage preconfigured connectors, reducing implementation time and cost.
Synapsys

Always Ready

Synapsys leverages QMS and DMS functionality and creates an exchange of information at the appropriate time and on an as needed basis.
On-Premise Ready

Cloud Ready

On-Premise Ready

On-Premise Ready

Our

SERVICES

Implementation Services

Technology Services - With our 25+ years of regulated industry experience and track record, we specialize in implementation, upgrade and migration services. Examples of technologies include Documentum, TrackWise, M-Files, MasterControl and others.

Validation Services

We are fully equipped and positioned to offer Product Development and full Computer System Validation Life Cycle Management based on SDLC and GAMP5.

Enterprise Content Migration Services

Data migration services - With a vast range of ETL migration tools and frameworks, we offer an end-to-end qualified and repeatable migration services.

Consulting Services

Our experienced professionals are experts and highly capable of providing business process consulting and technology services.

Technology

PARTNERS

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Client

TESTIMONIALS

“OpenText Documentum for Quality and Manufacturing enhanced our regulatory systems with process automation, greater control, better reporting and quick, easy access to documentation.”
-Asia's largest contract research &
manufacturing organization in Lifesciences
“A huge benefit of having integrated Documentum® and TrackWise EQMS® is the ability to have real time visibility into the end to end quality process and associated content which enables prompt action if needed.”
-Leading pharmaceutical company in the USA
Contact Us

Talk to us

Impact Systems, Inc

2116 Braken Ave
Wilmington, DE 19808
USA

Impact Systems Pvt. Ltd.

20, Durve House Society
Pune, Maharashtra 411037
India

Olympia Tech Park
Guindy, Chennai 600042
India

email
info@impactsystems.com